Chronic Obstructive Pulmonary Disease (COPD)CAPTURENCT03583099

The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3)

A study testing COPD plus CAPTURE education and patient-level information and COPD Education Only in people with Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A prospective, multicenter study including a cross-section validation to define sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant Chronic Obstructive Pulmonary Disease (COPD), and its impact on clinical care across a broad range of primary care settings in a… Read more about this study

Who is it for?: Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: COPD plus CAPTURE education and patient-level information and COPD Education Only
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,004 participants
Where: 9 sitesUnited States
Study dates: 12 Oct 2018to 7 Apr 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 45 - 80 years
4. Able to read and speak English or Spanish

Who cannot join

1. Previous clinician provided diagnosis of COPD
2. Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days
3. Participants unable to perform spirometry due to any of the following conditions within the past 30 days
Chest surgery
Abdominal surgery
Eye surgery
Heart attack
Stroke

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

High Plains Research Network
Aurora, Colorado, 80054
Circuit Clinical
Buffalo, New York, 14203
Atrium Healthcare
Charlotte, North Carolina, 28207
Cook County Hospital
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
Duke University
Durham, North Carolina, 27701
LANet
Los Angeles, California, 90802
COPD Foundation
Miami, Florida, 33134
Oregon Rural Practice-based Research Network (ORPRN)
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care

Read the detailed description

This is a large prospective, multi-center study explore the impact of the CAPTURE tool on clinical care and patient outcomes across a broad range of primary care settings in a cluster randomized controlled clinical trial.

The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD.

The CAPTURE study will enroll approximately 5,000 patients across 100 participating primary care clinics associated with practice-based research networks (PBRNs). Participants will be assessed with the CAPTURE Tool and have research spirometry testing.

Participating primary care practices will be randomized in a 1:1 fashion to one of the following interventions:

Arm 1: Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education (CAPTURE+ COPD education).
Arm 2: Practice clinicians will receive basic COPD education only (COPD education) and will be blinded to patient-level CAPTURE information.

A predefined subgroup of participants will undergo longitudinal follow-up at 12 months to determine the impact of the CAPTURE Tool on clinical care and patient outcomes. Participant reported data will be collected through in-person visits, telephone and mail-based methodologies, depending upon practice site preferences and feasibility. Clinic site data will also be collected from the medical record to assess for changes in practice-level care.

Primary outcome measure changes have been made in this ClinicalTrials.gov record because a planned part of the primary outcome measure was inadvertently missing from the initial draft of the protocol. It has been added to this ClinicalTrials.gov record to align with the most recent IRB-approved protocol. Secondary outcome measure changes were initiated as driven by the literature and advances in accepted methods of management and categorization of patients with COPD. An additional secondary outcome measure was added due to the COVID-19 pandemic. The changes have been made in ClinicalTrials.gov to align with the most recent IRB-approved protocol.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: COPD plus CAPTURE education and patient-level information, COPD Education Only
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COPD plus CAPTURE education and patient-level informationOther
Basic COPD Education plus CAPTURE education and patient-level CAPTURE information will be provided to all practice personnel randomized to the 'CAPTURE + COPD Education' arm.
COPD Education OnlyOther
Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.

Study groups in NCT03583099
Study group	Role	What they receive
COPD Education	Active comparator	Practice clinicians will receive basic COPD education only. Receives: Other: COPD Education Only
CAPTURE + COPD Education	Experimental	Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education. As the second aim address the optimal format for delivering practice CAPTURE education this will be incorporated at the sites randomized to this arm. Receives: Other: COPD plus CAPTURE education and patient-level information

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD
Proportion of CAPTURE+ participants who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months

Secondary outcomes (149)

Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below.
Proportion of CAPTURE+ participants currently smoking at the baseline visit who have any of the components of the Aim 3 primary endpoint: 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
OR
1. clinical counseling or recommendation for smoking cessation, 2) referral to a smoking cessation program, 3) referral to a smoking quit line, 4) newly prescribed medication for smoking cessation.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral for, or Complete Pulmonary Rehabilitation.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive Clinician Counseling or Recommendation for Smoking Cessation
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Smoking Cessation Program
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Capture Positive Participants Currently Smoking at Baseline Who Referral to a Smoking Quit Line
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Newly Prescribed Medication for Smoking Cessation.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants
The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact.
CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (<350 L/min for males,<250 L/min for females). Higher values = higher likelihood of COPD.
The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months.
Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change.
The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Who Experience Exacerbations.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Exacerbation is defined as acute respiratory illness requiring antibiotic/steroid during follow-up.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with clinically significant COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. (composite endpoint)
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Clinical Spirometry Testing
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD With a New Diagnosis of COPD
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD With a Referral to a Specialist for Respiratory Evaluation/Treatment
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Pulmonary Rehabilitation.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Who Receive a Recommendation for or Administration of Influenza Vaccination
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with spirometric COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Referred for or Completion of Clinical Spirometry Testing
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD With a New Diagnosis of COPD.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Referred to a Specialist for Respiratory Evaluation/Treatment
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Who Are Referred for or Complete Pulmonary Rehabilitation.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Who Receive a Recommendation for or Administration of Influenza Vaccination.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Who Meet Any of the Components of the Primary Endpoint
Proportion of participants with Mild COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Referred for or Completion of Clinical Spirometry Testing
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD With a New Diagnosis of COPD
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Referred to a Specialist for Respiratory Evaluation/Treatment
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Referred for or Completion of Pulmonary Rehabilitation.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Who Received a Recommendation or Administration of Influenza Vaccination.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with preserved ratio, impaired spirometry (PRISm) who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Clinical Spirometry Testing.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With New Diagnosis of COPD.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred to a Specialist for Respiratory Evaluation/Treatment
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Pulmonary Rehabilitation.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Receive a Recommendation for or Administration of Influenza Vaccination.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Meet Any of the Components of the Primary Endpoint.
Proportion of participants with symptomatic non-obstructed (SNO) meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC<0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Clinical Spirometry Testing.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.
The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) With a New Diagnosis of COPD
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.
The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.
The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred to a Specialist for Respiratory Evaluation/Treatment
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.
The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Pulmonary Rehabilitation.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.
The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Who Receive a Recommendation or Administration of Influenza Vaccination.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.
The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of CAPTURE+ participants enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of CAPTURE+ participants enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Newly Diagnosed With COPD
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Newly Diagnosed With COPD
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Have Received a Recommendation for, or Administration of Influenza Vaccination
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled Before March 20, 2019
The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact.
CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (<350 L/min for males,<250 L/min for females). Higher values = higher likelihood of COPD.
The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months.
Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change.
The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Measured: Baseline to 12 months
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled on or After March 20, 2019
The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact.
CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (<350 L/min for males,<250 L/min for females). Higher values = higher likelihood of COPD.
The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months.
Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change.
The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Exacerbations.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low peak expiratory flow (PEF), defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Exacerbation is defined as acute respiratory illness requiring antibiotic/steroid during follow-up.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Exacerbations.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low peak expiratory flow (PEF), defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Meet Any of Components of the Primary Endpoints.
Proportion of participants with clinically significant COPD enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 Who Meet Any of Components of the Primary Endpoints.
Proportion of participants with clinically significant COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 a New Diagnosis of COPD
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description)
Clinically significant COPD = post-bronchodilator FEV1/FVC <0.7, plus: 1) FEV1 < 60% predicted or 2) > 1 exacerbation like event in the last year.
The generalized estimating equation (GEE) model for the Proportion:
Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome.
EUC proportion = intercept. Intervention proportion = intercept + slope.
Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)
When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Measured: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Enrolled After August 13, 2020 Who Receive a Recommendation for or Administration of Influenza Vaccination
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
Proportion of participants with spirometric COPD enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
Proportion of participants with spirometric COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description)
Spirometric COPD: post-bronch FEV1/FVC <0.7. If only pre-bronch spirometry is available and FEV1/FVC < 0.65, subject will be considered to have COPD.
The generalized estimating equation (GEE) model for the Proportion:
Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome.
EUC proportion = intercept. Intervention proportion = intercept + slope.
Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)
When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment (Abbreviated as Proportion in the Description)
Spirometric COPD: post-bronch FEV1/FVC <0.7. If only pre-bronch spirometry is available and FEV1/FVC < 0.65, participant will be considered to have COPD.
The generalized estimating equation (GEE) model for the Proportion:
Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome.
EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)
When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline to 12 months
Proportion of Mild COPD Participants Enrolled Before 3/20/2019 With Any of :1) Clinical Spirometry Referral, 2) New COPD Diagnosis, 3) Newly Prescribed Respiratory Medication, 4) Respiratory Specialist Referral, 5) Referral/Completion of Pulmonary Rehab
Respiratory medication = long acting bronchodilator or anti-inflammatory
Mild COPD = post-bronch FEV1/FVC<0.7 plus 1) FEV1 ≥ 60% and 2) No prior COPD exacerbation
The generalized estimating equation (GEE) model for the Proportion:
Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) aren't based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome
EUC proportion = intercept. Intervention proportion = intercept + slope Intervention - EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)
When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcome between subjects in same practice
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
Proportion of participants with mild COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description)
Mild COPD = post-bronch FEV1/FVC<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
The generalized estimating equation (GEE) model for the Proportion:
Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are on the scale from 0% to 100%. Ie. 50.0 = 50% met outcome.
EUC proportion = intercept. Intervention proportion = intercept + slope.
Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference).
When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description)
Mild COPD = post-bronchodilator FEV1/FVC<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
The generalized estimating equation (GEE) model for the Proportion:
Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome
EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)
When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication (Abbreviated as Proportion in the Description)
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Mild COPD = post-bronchodilator FEV1/FVC<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD
The generalized estimating equation (GEE) model for the Proportion:
Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome
EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)
When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and c
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With New Diagnosis of COPD
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With New Diagnosis of COPD
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description)
Preserved ratio, impaired spirometry (PRISm) = participants without spirometrically defined COPD who have post-bronch FEV1 < 80% predicted.
The generalized estimating equation (GEE) model for the Proportion:
Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits are not based on raw data proportions. Reported units are on the scale from 0% to 100%. Ie. 50.0 = 50% met outcome.
EUC proportion = intercept. Intervention proportion = intercept + slope.
Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference).
When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for the different numbers of subjects in practices and correlation of outcomes in the same practice.
Measured: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with symptomatic non-obstructed (SNO) enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description)
SNO = post-bronch FEV1/FVC ≥ 0.7 and post-bronch FEV1 ≥ 80% predicted and a COPD Assessment Test (CAT) score ≥ 10. The CAT is scored 0-40. Higher score = more severe COPD
The generalized estimating equation (GEE) model for the Proportion:
Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits not based on raw data proportions. Reported units are on the scale from 0% - 100%. Ie. 50 = 50% met outcome
EUC proportion = intercept. Intervention proportion = intercept + slope
Intervention - EUC proportion = slope. Ie 10 = Intervention met outcome 10% > EUC (absolute difference)
When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for the different numbers of subjects in practices and correlation of outcomes in the same practice
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Received Over-the-counter Patches/Gum for Smoking Cessation
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Who Experience Hospitalizations
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Number of Enrolled CAPTURE+ Participants Who Experience Mortality
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Hospitalizations
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Hospitalizations
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Number of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Mortality.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months
Number of CAPTURE+ Participants Enrolled After March 20, 2019 Who Experience Mortality.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.
CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 20187 Apr 2023

First posted11 Jul 2018
Study start12 Oct 2018
Primary completion7 Apr 2023
Study completion7 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participating primary practices will be randomized to one of 2 arms. * Arm 1: Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education (CAPTURE+ COPD education). * Arm 2: Practice clinicians will receive basic COPD education only (COPD education).
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 2,004 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03583099
Sponsor's protocol ID: 1803019032-3
Other IDs: R01HL136682-01
Acronym: CAPTURE
Status last verified: Sep 2024
First submitted: 5 Mar 2018
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.
PubMed 35514131

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
cfMSC Stem Cell Therapy Targeting COPD
Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)

All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
ClinicalTrials.gov ID: NCT03583099
Acronym / sponsor ID: CAPTURE / 1803019032-3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,004 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), University of Michigan, National Jewish Health, Wake Forest University Health Sciences, Duke University, High Plains Research Network, L.A. Net Community Health Resource Network, Oregon Health and Science University, University of Kentucky, University of Minnesota, COPD Foundation
Study start: 12 Oct 2018 (actual)
Primary completion: 7 Apr 2023 (actual)
Study completion: 7 Apr 2023 (actual)
First posted: 11 Jul 2018 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD.

Participating primary care practices will be randomized in a 1:1 fashion to one of the following interventions:

Arm 1: Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education (CAPTURE+ COPD education).
Arm 2: Practice clinicians will receive basic COPD education only (COPD education) and will be blinded to patient-level CAPTURE information.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: Participating primary practices will be randomized to one of 2 arms. * Arm 1: Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education (CAPTURE+ COPD education). * Arm 2: Practice clinicians will receive basic COPD education only (COPD education).

Arm	Type	Receives
COPD Education	Active comparator	Other: COPD Education OnlyPractice clinicians will receive basic COPD education only.
CAPTURE + COPD Education	Experimental	Other: COPD plus CAPTURE education and patient-level informationPractice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education. As the second aim address the optimal format for delivering practice CAPTURE education this will be incorporated at the sites randomized to this arm.

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 45 - 80 years
4. Able to read and speak English or Spanish

Key exclusion criteria (8 listed)

1. Previous clinician provided diagnosis of COPD
2. Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days
3. Participants unable to perform spirometry due to any of the following conditions within the past 30 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COPD plus CAPTURE education and patient-level informationBasic COPD Education plus CAPTURE education and patient-level CAPTURE information will be provided to all practice personnel randomized to the 'CAPTURE + COPD Education' arm.	Other	CAPTURE + COPD Education
COPD Education OnlyPractice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.	Other	COPD Education

Primary outcome

Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD
Time frame: Baseline to 12 months
Proportion of CAPTURE+ participants who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

149 secondary outcomes

Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination.
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below.
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral for, or Complete Pulmonary Rehabilitation.
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive Clinician Counseling or Recommendation for Smoking Cessation
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Smoking Cessation Program
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Capture Positive Participants Currently Smoking at Baseline Who Referral to a Smoking Quit Line
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Newly Prescribed Medication for Smoking Cessation.
Time frame: Baseline to 12 months
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants
Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Who Experience Exacerbations.
Time frame: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Who Meet Any of the Components of the Primary Endpoint.
Time frame: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Clinical Spirometry Testing
Time frame: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD With a New Diagnosis of COPD
Time frame: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD With a Newly Prescribed Respiratory Medication
Time frame: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD With a Referral to a Specialist for Respiratory Evaluation/Treatment
Time frame: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Pulmonary Rehabilitation.
Time frame: Baseline to 12 months
Proportion of Participants With Clinically Significant COPD Who Receive a Recommendation for or Administration of Influenza Vaccination
Time frame: Baseline to 12 months
Proportion of Participants With Spirometric COPD Who Meet Any of the Components of the Primary Endpoint.
Time frame: Baseline to 12 months
Proportion of Participants With Spirometric COPD Referred for or Completion of Clinical Spirometry Testing
Time frame: Baseline to 12 months
Proportion of Participants With Spirometric COPD With a New Diagnosis of COPD.
Time frame: Baseline to 12 months
Proportion of Participants With Spirometric COPD With Newly Prescribed Respiratory Medication
Time frame: Baseline to 12 months
Proportion of Participants With Spirometric COPD Referred to a Specialist for Respiratory Evaluation/Treatment
Time frame: Baseline to 12 months
Proportion of Participants With Spirometric COPD Who Are Referred for or Complete Pulmonary Rehabilitation.
Time frame: Baseline to 12 months
Proportion of Participants With Spirometric COPD Who Receive a Recommendation for or Administration of Influenza Vaccination.
Time frame: Baseline to 12 months
Proportion of Participants With Mild COPD Who Meet Any of the Components of the Primary Endpoint
Time frame: Baseline to 12 months
Proportion of Participants With Mild COPD Referred for or Completion of Clinical Spirometry Testing
Time frame: Baseline to 12 months
Proportion of Participants With Mild COPD With a New Diagnosis of COPD
Time frame: Baseline to 12 months
Proportion of Participants With Mild COPD With a Newly Prescribed Respiratory Medication
Time frame: Baseline to 12 months
Proportion of Participants With Mild COPD Referred to a Specialist for Respiratory Evaluation/Treatment
Time frame: Baseline to 12 months
Proportion of Participants With Mild COPD Referred for or Completion of Pulmonary Rehabilitation.
Time frame: Baseline to 12 months
Proportion of Participants With Mild COPD Who Received a Recommendation or Administration of Influenza Vaccination.
Time frame: Baseline to 12 months
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Meet Any of the Components of the Primary Endpoint.
Time frame: Baseline to 12 months

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	1,118	802
Enhanced Usual Care: COPD Education	886	613

Primary outcome: Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD

Time frame: Baseline to 12 months. Number (95% Confidence Interval). Unit: percent

Measure	Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results n = 226	Enhanced Usual Care: COPD Education n = 161
Value	45.9 (38.3 to 53.6)	41.9 (34.0 to 49.7)

Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results vs Enhanced Usual Care: COPD Education: Difference in proportion: 4.0 (95% CI -6.9 to 15.0), p = 0.47, generalized estimating equation contrast

149 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AE)s occurring at the Baseline Visit only were collected for all participants, per study protocol. Mortality data was only collected via medical records from Baseline to 12 months in individuals identified as CAPTURE+ at baseline. Note that, in contrast, the primary analysis population required completion of the 12-month follow-up survey, which required them to be alive at 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	0 of 1,118 (0%)	0 of 1,118 (0%)	2 of 331
Enhanced Usual Care Arm: COPD Education	0 of 886 (0%)	0 of 886 (0%)	2 of 225

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35514131Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

Not yet recruitingPhase 1/2
cfMSC Stem Cell Therapy Targeting COPD
Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fernando J Martinez, MD, MS principal investigator

Weill Medical College of Cornell University

MeiLan Han, MD, MS principal investigator

University of Michigan

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03583099, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.