Chronic Obstructive Pulmonary Disease (COPD)CAPTURENCT03653611
The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 2)
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 6 sites in United States.
Trial summary
This is a qualitative research exploration engaging clinical staff at all levels from 10 Practice-Based Research Networks (PBRNs) serving US patient populations of differing gender, racial, ethnic, urban/rural and socio-economic blends, in the incorporation of a one-page, five-item questionnaire with selective PEF… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- On-site Practice Assessment, Clinical Staff Questionnaires and Patient Opinion Surveys
- How many people
- 196 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Jul 2018to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Practices participating in Aim 2, will be selected by each of their 5 affiliated PBRNs based upon willingness to participate and variability of primary care practice type within the PBRN. Differences in practice size, staffing, ownership, prior quality improvement engagement, geography, patient population socioeconomic status (SES) or languages spoken are among the among the selection criteria the PBRNs will utilize to choose.
Who may be able to join
- Clinician Participants:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with availability and all study procedures for the duration of the study by the 10 practices (through PBRN recruitment) and their up to 15 clinicians within (through informed consent).
- Male or female, aged 45 - 80 years
- Patient participants [200 participants enrolled in Aim 1 of the CAPTURE Study for an opinion survey]:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 45 - 80 years.
Who cannot join
- Clinician participants: current employment at practices participating in aims 1 and/or 3
- Clinician participants: from practices providing fewer than 2 clinician participants
- Patient participants: meeting the exclusion criteria for aims 1 and 3 (above)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
High Plains Research Network
Aurora, Colorado, 80054
Atrium Healthcare
Charlotte, North Carolina, 28207
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
About this study
Official title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
This is a qualitative research exploration engaging clinical staff at all levels from 10 Practice-Based Research Networks (PBRNs) serving US patient populations of differing gender, racial, ethnic, urban/rural and socio-economic blends, in the incorporation of a one-page, five-item questionnaire with selective PEF measurement (CAPTURE).
Read the detailed description
This is a prospective, multi-center qualitative study engaging clinical staff at all levels from primary care practices serving US patient populations of differing gender, racial, ethnic, urban/rural and socio-economic blends.
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.
This study will assess, using the RE-AIM approach, how real-word primary care practices might potentially use CAPTURE to: a) identify target populations (Reach); b) appraise optimal targeted respiratory history and symptoms consistent with clinically significant COPD (Effectiveness); c) integrate into practice workflow (Adoption); d) deliver changes and improvements to COPD care within the scope of real-world clinical practice (Implementation); and e) persist in use and quality over time (Maintenance).
Approximately 150 clinicians from 10 participating primary care practices will undergo detailed implementation investigation of the CAPTURE case finding model for clinically significant COPD. In addition, 200 enrolled participants will complete a 10-minute written CAPTURE opinion survey.
Using the RE-AIM framework and consistent phased qualitative analyses, this aim ascertains reach, impact, adoption, implementation and maintenance primary care feasibility recommendation characteristics of CAPTURE via pooled assessment of prescriber clinical staff, non-prescriber clinical staff, CAPTURE-eligible patients and local PBRN clinical quality improvement expertise from 10 primary care practices across 5 US regions.
- Being tested
- On-site Practice Assessment, Clinical Staff Questionnaires, Patient Opinion Surveys, Modular online COPD Education, COPD in Primary Care/CAPTURE Introduction Focus Groups
- Keywords
- COPD, CAPTURE, Chronic Obstructive Pulmonary Disease
- 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.
On-site Practice AssessmentOther
The assessment takes place in three parts; the pre-observation practice overview (conducted with the 2 practice clinicians - 60 minutes), the ½ day practice workflow observation (observation by one member of the Aim 2 research team of common and testing areas used for the respiratory patient). There is no patient engagement and no collection of patient-specific identification or health information), and the post-observation practice summary (conducted with the same 2 practice clinicians - 30 minutes).
Clinical Staff QuestionnairesOther
Written or on-line questionnaires are provided to participating and consented staff personnel at two practice levels -- Non-Prescribing clinical (also known as "support") staff and Prescribing (PR) clinical (also known as "provider") staff.
Patient Opinion SurveysOther
200 Eligible participants will complete a one-time 5 to 10 minute CAPTURE opinion survey.
Modular online COPD EducationOther
Access to free, COPD on-line, continuing education is provided for all clinical staff at each practice. Each module will take 20 minutes or less. Aim 2 clinician participant access and completion of COPD education modules is assessed by clinician questionnaires and focus group item response over 12 months (between months 2 and 14 of Aim 2 timeline).
COPD in Primary Care/CAPTURE Introduction Focus GroupsOther
Two 45 to 60-minute focus group discussions occur at each Aim 2 practice. Focus groups are informed by practice demographics, practice assessment data, as well as patient opinion from CAPTURE surveys and past CAPTURE study. Focus group candidate themes and prompts are developed for non-prescribing clinical staff (NPR) and prescribing clinical staff (PR) and are presented at separate on-site focus group sessions to allow more detailed discussion of role responsibility in the context of daily practice workflow.
| Study group | Role | What they receive |
|---|---|---|
| Clinician Participants | Two Aim 2 practices are selected by each of their 5 affiliated PBRNs based upon willingness to participate and variability of primary care practice type within the PBRN. Differences in practice size, staffing, ownership, prior quality improvement engagement, geography, patient population socioeconomic status (SES) or languages spoken are among the among the selection criteria the PBRNs will utilize to choose. Receives: Other: On-site Practice Assessment; Other: Clinical Staff Questionnaires; Other: Modular online COPD Education; Other: COPD in Primary Care/CAPTURE Introduction Focus Groups | |
| Patient Participants | 200 patients, who are enrolled in Aim 1 (approximately 40 from each PBRN) will be invited to take a CAPTURE opinion survey Receives: Other: Patient Opinion Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary care clinician perspective on implementing CAPTURE into primary care practice.
Primary care clinician perspective on implementing CAPTURE will be assessed using the RE-AIM approach in two focus group sessions consisting of clinical staff self-reporting current clinical practices, the process for implementing a new tool into practice and review of the CAPTURE tool.
Measured: Baseline to 2 years
Secondary outcomes (11)
Primary care clinician knowledge about respiratory care at the provider level.
Primary care clinician knowledge will be assessed using a questionnaire to self report about knowledge and beliefs regard Chronic Obstructive Pulmonary Disease (COPD) and COPD management.
Measured: Baseline to 2 years
Primary care clinician knowledge about respiratory care at the provider level.
Primary care clinician knowledge will be assessed using two focus groups to self report on the staff's knowledge regarding respiratory care.
Measured: Baseline to 2 years
Primary care clinician attitudes and beliefs regarding respiratory care and communication within their current practice.
Primary care clinician attitudes and beliefs will be assessed using a questionnaire to self report respiratory care in their current practice.
Measured: Baseline to 2 years
Primary care clinician self-efficacy in provider-specific respiratory clinical care.
Primary care clinician self-efficacy will be assessed using two focus groups to self report on the staff's perspective regarding self-efficacy of provider-specific respiratory practices.
Measured: Baseline to 2 years
Primary care clinician attitudes and beliefs about clinical quality improvement and communication within their current practice.
Primary care clinician attitudes and beliefs regarding quality improvement and communication within their current practice will be assessed using two focus groups to self report attitude and beliefs.
Measured: Baseline to 2 years
Existing COPD Clinical care operations within a variety of primary care practices.
COPD clinical care operations at various practices will be assessed using two focus groups to self report current COPD clinical care operations within primary care clinicians own practices.
Measured: Baseline to 2 years
Existing COPD Clinical care operations within a variety of primary care practices.
Details of COPD clinical care operations at various practices will be assessed using a questionnaire to self report current COPD clinical care operations within primary care clinicians own practices.
Measured: Baseline to 2 years
Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.
Primary care clinician attitudes and beliefs regarding screening and diagnostic assessment strategies and communication within their current practice will be assessed using two focus groups to self report attitude and beliefs.
Measured: Baseline to 2 years
Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.
Primary care clinician attitudes and beliefs regarding screening and diagnostic assessment strategies and communication within their current practice will be assessed using a prescriber questionnaire to self report attitude and beliefs.
Measured: Baseline to 2 years
Patient comprehension of CAPTURE tool instructions and questions.
Patient comprehension of CAPTURE tool instructions and questions will be assessed using a CAPTURE opinion survey to self report comprehension.
Measured: Baseline to 2 years
Patient ease of completion of the CAPTURE tool.
Patients' ease of completion of the CAPTURE tool will be assessed using a CAPTURE opinion survey to self report ease of completion.
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start30 Jul 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, 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 Minnesota, University of Kentucky, COPD Foundation
- Responsible party
- Sponsor
- Investigators
- Fernando J Martinez, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653611
- Sponsor's protocol ID
- 1803019032-2
- Other IDs
- R01HL136682-01
- Acronym
- CAPTURE
- Status last verified
- Jul 2022
- First submitted
- 26 Jun 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. 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
- NCT03653611
- Acronym / sponsor ID
- CAPTURE / 1803019032-2
- Keywords
- COPD, CAPTURE, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 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 Minnesota, University of Kentucky, COPD Foundation
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a qualitative research exploration engaging clinical staff at all levels from 10 Practice-Based Research Networks (PBRNs) serving US patient populations of differing gender, racial, ethnic, urban/rural and socio-economic blends, in the incorporation of a one-page, five-item questionnaire with selective PEF measurement (CAPTURE).
Detailed description
This is a prospective, multi-center qualitative study engaging clinical staff at all levels from primary care practices serving US patient populations of differing gender, racial, ethnic, urban/rural and socio-economic blends.
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.
This study will assess, using the RE-AIM approach, how real-word primary care practices might potentially use CAPTURE to: a) identify target populations (Reach); b) appraise optimal targeted respiratory history and symptoms consistent with clinically significant COPD (Effectiveness); c) integrate into practice workflow (Adoption); d) deliver changes and improvements to COPD care within the scope of real-world clinical practice (Implementation); and e) persist in use and quality over time (Maintenance).
Approximately 150 clinicians from 10 participating primary care practices will undergo detailed implementation investigation of the CAPTURE case finding model for clinically significant COPD. In addition, 200 enrolled participants will complete a 10-minute written CAPTURE opinion survey.
Using the RE-AIM framework and consistent phased qualitative analyses, this aim ascertains reach, impact, adoption, implementation and maintenance primary care feasibility recommendation characteristics of CAPTURE via pooled assessment of prescriber clinical staff, non-prescriber clinical staff, CAPTURE-eligible patients and local PBRN clinical quality improvement expertise from 10 primary care practices across 5 US regions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinician Participants | – | Other: On-site Practice Assessment, Other: Clinical Staff Questionnaires, Other: Modular online COPD Education, Other: COPD in Primary Care/CAPTURE Introduction Focus GroupsTwo Aim 2 practices are selected by each of their 5 affiliated PBRNs based upon willingness to participate and variability of primary care practice type within the PBRN. Differences in practice size, staffing, ownership, prior quality improvement engagement, geography, patient population socioeconomic status (SES) or languages spoken are among the among the selection criteria the PBRNs will utilize to choose. |
| Patient Participants | – | Other: Patient Opinion Surveys200 patients, who are enrolled in Aim 1 (approximately 40 from each PBRN) will be invited to take a CAPTURE opinion survey |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Practices participating in Aim 2, will be selected by each of their 5 affiliated PBRNs based upon willingness to participate and variability of primary care practice type within the PBRN. Differences in practice size, staffing, ownership, prior quality improvement engagement, geography, patient population socioeconomic status (SES) or languages spoken are among the among the selection criteria the PBRNs will utilize to choose.
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with availability and all study procedures for the duration of the study by the 10 practices (through PBRN recruitment) and their up to 15 clinicians within (through informed consent).
- Male or female, aged 45 - 80 years
- Patient participants [200 participants enrolled in Aim 1 of the CAPTURE Study for an opinion survey]:
- Provision of signed and dated informed consent form.
Key exclusion criteria (3 listed)
- Clinician participants: current employment at practices participating in aims 1 and/or 3
- Clinician participants: from practices providing fewer than 2 clinician participants
- Patient participants: meeting the exclusion criteria for aims 1 and 3 (above)
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 |
|---|---|---|
| On-site Practice AssessmentThe assessment takes place in three parts; the pre-observation practice overview (conducted with the 2 practice clinicians - 60 minutes), the ½ day practice workflow observation (observation by one member of the Aim 2 research team of common and testing areas used for the respiratory patient). There is no patient engagement and no collection of patient-specific identification or health information), and the post-observation practice summary (conducted with the same 2 practice clinicians - 30 minutes). | Other | Clinician Participants |
| Clinical Staff QuestionnairesWritten or on-line questionnaires are provided to participating and consented staff personnel at two practice levels -- Non-Prescribing clinical (also known as "support") staff and Prescribing (PR) clinical (also known as "provider") staff. | Other | Clinician Participants |
| Patient Opinion Surveys200 Eligible participants will complete a one-time 5 to 10 minute CAPTURE opinion survey. | Other | Patient Participants |
| Modular online COPD EducationAccess to free, COPD on-line, continuing education is provided for all clinical staff at each practice. Each module will take 20 minutes or less. Aim 2 clinician participant access and completion of COPD education modules is assessed by clinician questionnaires and focus group item response over 12 months (between months 2 and 14 of Aim 2 timeline). | Other | Clinician Participants |
| COPD in Primary Care/CAPTURE Introduction Focus GroupsTwo 45 to 60-minute focus group discussions occur at each Aim 2 practice. Focus groups are informed by practice demographics, practice assessment data, as well as patient opinion from CAPTURE surveys and past CAPTURE study. Focus group candidate themes and prompts are developed for non-prescribing clinical staff (NPR) and prescribing clinical staff (PR) and are presented at separate on-site focus group sessions to allow more detailed discussion of role responsibility in the context of daily practice workflow. | Other | Clinician Participants |
Primary outcome
Primary care clinician perspective on implementing CAPTURE into primary care practice.
Time frame: Baseline to 2 years
Primary care clinician perspective on implementing CAPTURE will be assessed using the RE-AIM approach in two focus group sessions consisting of clinical staff self-reporting current clinical practices, the process for implementing a new tool into practice and review of the CAPTURE tool.
11 secondary outcomes
Primary care clinician knowledge about respiratory care at the provider level.
Time frame: Baseline to 2 years
Primary care clinician knowledge about respiratory care at the provider level.
Time frame: Baseline to 2 years
Primary care clinician attitudes and beliefs regarding respiratory care and communication within their current practice.
Time frame: Baseline to 2 years
Primary care clinician self-efficacy in provider-specific respiratory clinical care.
Time frame: Baseline to 2 years
Primary care clinician attitudes and beliefs about clinical quality improvement and communication within their current practice.
Time frame: Baseline to 2 years
Existing COPD Clinical care operations within a variety of primary care practices.
Time frame: Baseline to 2 years
Existing COPD Clinical care operations within a variety of primary care practices.
Time frame: Baseline to 2 years
Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.
Time frame: Baseline to 2 years
Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.
Time frame: Baseline to 2 years
Patient comprehension of CAPTURE tool instructions and questions.
Time frame: Baseline to 2 years
Patient ease of completion of the CAPTURE tool.
Time frame: Baseline to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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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 principal investigator
Weill Medical College of Cornell University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 6 sites in United States.
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 8 inclusion and 3 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary care clinician perspective on implementing CAPTURE into primary care practice. (time frame: Baseline to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2023.