Pulmonary Disease, Chronic ObstructiveNCT02725294
Understanding Patient Management of COPD Exacerbations
An observational study of Pulmonary Disease, Chronic Obstructive, run by VA Puget Sound Health Care System.
Trial summary
This observational study will examine the care-seeking behaviors of Veterans with chronic obstructive pulmonary disease (COPD) to see whether patients' perceived need for care or lack of access to care leads to delays in getting care for COPD exacerbations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- This is an observational study without an intervention
- How many people
- 436 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic obstructive pulmonary disease (COPD) who receive care at the VA Puget Sound Health Care System in Seattle, WA or the VA Eastern Colorado Health Care System in Denver, CO. Informal caregivers (ie. family member or friend) to the Veteran subject will also be included
Who may be able to join
- COPD diagnosis
- Spirometry showing FEV1/VC<0.70
- COPD exacerbation treated with prednisone and/or antibiotics, or that resulted in a visit to the emergency department or hospitalization in the previous 12 months
- English speaking
- Access to telephone
- Identified by Veteran patient as informal caregiver
Show all 9Show fewer
- English speaking
- Access to telephone
- >=18 years old
Who cannot join
- nursing home resident
- institutionalized, imprisoned
- life expectancy < 1 year
- Informal Caregiver Cohort:
About this study
This observational study will examine the care-seeking behaviors of Veterans with chronic obstructive pulmonary disease (COPD) to see whether patients' perceived need for care or lack of access to care leads to delays in getting care for COPD exacerbations. Participants complete a baseline in-person visit and receive calls every two weeks for one year to monitor for COPD exacerbations. Detailed information about each exacerbation and time to care are obtained. A sample of participants and their caregivers participate in in-depth interviews. Approximately half the participants will also use a remote inhaler monitor to record their albuterol inhaler use to see if this approach can identify early exacerbations. Results from this study will be used to develop an intervention that will assist Veterans in the early identification, evaluation, and treatment of exacerbations, and will be integrated with the VA primary care team.
Read the detailed description
Prompt treatment of chronic obstructive pulmonary disease (COPD) exacerbations with oral steroids and/or antibiotics, ideally within 3 days of onset of symptoms, can decrease the severity and duration of exacerbations and may reduce the risk of COPD hospitalizations. This observational study will examine Veterans' care-seeking behaviors and will focus on patients' perceived need for care and perceived access to care and whether these factors delay seeking care for COPD exacerbations, increasing the risk for hospitalizations. This study will also evaluate one approach of identifying early exacerbations through the use of a remote inhaler monitoring system.
This observational cohort study enrolled 412 Veterans with COPD at high-risk for exacerbations. As of March 2019, 246 participants have completed the 1 year follow-up; 133 are in follow-up. The Specific Aims are: 1) Examine the barriers to seeking care for COPD exacerbations or worsening breathing; 2) Test the use of a real-time remote inhaler monitor to identify early exacerbations.
All participants attended one in-person baseline visit to complete spirometry and baseline questionnaires. Participants are contacted every 2 weeks for 1 year using an interactive voice response system that screens for COPD exacerbations with 4 yes/no questions. Participants with a positive screen are called back by research staff to obtain additional detailed information on the exacerbation and how it was treated. Data analysis will examine whether access to care and baseline factors are associated with a delay in treatment.
The participants enrolled at two sites: 252 participants at VA Puget Sound in Seattle, WA and 160 participants at the VA Eastern Colorado in Denver, CO. For Aim 1, 60 participants who reported a COPD exacerbation (either hospitalized, seen in the emergency department, treated as outpatients, or did not seek treatment) participated in in-depth semi-structured interviews by a trained research staff to understand how they responded to their worsening symptoms and decided whether to seek care. 24 caregivers for these Veterans were interviewed about their perspective on the exacerbation event.
In Aim 2, 145 participants from Aim 1 used an inhaler monitor with their albuterol inhaler during the 12-month follow-up period, which transmits real-time data about their daily inhaler use. Data analysis will measure whether a change in albuterol use can predict patient reported COPD exacerbations to determine the appropriate cut-offs that can be used in a future intervention trial.
These aims will provide detailed information on how best to intervene to ensure prompt identification and treatment of COPD exacerbations. New health care delivery approaches will assist Veterans in early identification of exacerbations and provide early access to care that can be integrated into the VA primary care, emergency medicine and pulmonary specialty care settings.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- This is an observational study without an intervention
- Keywords
- exacerbation, access to care, telemedicine
- 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.
This is an observational study without an interventionOther
Not applicable. This is an observational study without an intervention.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Veterans with COPD who are cared for at VA Puget Sound Health Care System (Seattle, WA) or VA Eastern Colorado (Denver, CO) who are at high risk for a COPD exacerbation based on an exacerbation treated with prednisone or antibiotics in the year preceding enrollment. Receives: Other: This is an observational study without an intervention | |
| Informal Caregiver for COPD patients | Informal caregiver (ie. family member, friend, etc.) for the patient with COPD who is participating in the COPD patients cohort. Receives: Other: This is an observational study without an intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision to seek care
All participants with at least one exacerbation will be included in this analysis. Individuals could have both treated or untreated exacerbations and the unit of analysis will be each patient-exacerbation event. The outcome will be whether the patient sought treatment (yes/no) for their COPD exacerbation.
Measured: Determined for each exacerbation event during the 1-year follow-up period
Secondary outcomes (1)
Treatment delay
Only patients with ≥1 treated exacerbation during follow-up will be included in this analysis. A patient could have more than one exacerbation, and the unit of analysis will be each patient-exacerbation event
Measured: Determined for each treated exacerbation event during the 1-year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2019 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Collaborators
- VA Eastern Colorado Health Care System, VA Palo Alto Health Care System
- Responsible party
- Principal investigator, Vincent S. Fan, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725294
- Sponsor's protocol ID
- 00874
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2016
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Locke ER, Thomas RM, Simpson TL, Fortney JC, Battaglia C, Trivedi RB, Gylys-Colwell J, Swenson ER, Edelman JD, Fan VS. Cognitive and Emotional Responses to Chronic Obstructive Pulmonary Disease Exacerbations and Patterns of Care Seeking. Ann Am Thorac Soc. 2024 Apr;21(4):559-567. doi: 10.1513/AnnalsATS.202303-287OC.
PubMed 37966313Locke ER, Young JP, Battaglia C, Simpson TL, Trivedi R, Simons C, Fortney JC, Hebert P, Swenson ER, Edelman J, Fan VS. Care-seeking and delay of care during COPD exacerbations. NPJ Prim Care Respir Med. 2022 Feb 15;32(1):7. doi: 10.1038/s41533-022-00269-9.
PubMed 35169140
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Patient Management of COPD Exacerbations
- ClinicalTrials.gov ID
- NCT02725294
- Acronym / sponsor ID
- 00874
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- exacerbation, access to care, telemedicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 436 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Collaborators
- VA Eastern Colorado Health Care System, VA Palo Alto Health Care System
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 31 Mar 2016 (estimated)
- 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 observational study will examine the care-seeking behaviors of Veterans with chronic obstructive pulmonary disease (COPD) to see whether patients' perceived need for care or lack of access to care leads to delays in getting care for COPD exacerbations. Participants complete a baseline in-person visit and receive calls every two weeks for one year to monitor for COPD exacerbations. Detailed information about each exacerbation and time to care are obtained. A sample of participants and their caregivers participate in in-depth interviews. Approximately half the participants will also use a remote inhaler monitor to record their albuterol inhaler use to see if this approach can identify early exacerbations. Results from this study will be used to develop an intervention that will assist Veterans in the early identification, evaluation, and treatment of exacerbations, and will be integrated with the VA primary care team.
Detailed description
Prompt treatment of chronic obstructive pulmonary disease (COPD) exacerbations with oral steroids and/or antibiotics, ideally within 3 days of onset of symptoms, can decrease the severity and duration of exacerbations and may reduce the risk of COPD hospitalizations. This observational study will examine Veterans' care-seeking behaviors and will focus on patients' perceived need for care and perceived access to care and whether these factors delay seeking care for COPD exacerbations, increasing the risk for hospitalizations. This study will also evaluate one approach of identifying early exacerbations through the use of a remote inhaler monitoring system.
This observational cohort study enrolled 412 Veterans with COPD at high-risk for exacerbations. As of March 2019, 246 participants have completed the 1 year follow-up; 133 are in follow-up. The Specific Aims are: 1) Examine the barriers to seeking care for COPD exacerbations or worsening breathing; 2) Test the use of a real-time remote inhaler monitor to identify early exacerbations.
All participants attended one in-person baseline visit to complete spirometry and baseline questionnaires. Participants are contacted every 2 weeks for 1 year using an interactive voice response system that screens for COPD exacerbations with 4 yes/no questions. Participants with a positive screen are called back by research staff to obtain additional detailed information on the exacerbation and how it was treated. Data analysis will examine whether access to care and baseline factors are associated with a delay in treatment.
The participants enrolled at two sites: 252 participants at VA Puget Sound in Seattle, WA and 160 participants at the VA Eastern Colorado in Denver, CO. For Aim 1, 60 participants who reported a COPD exacerbation (either hospitalized, seen in the emergency department, treated as outpatients, or did not seek treatment) participated in in-depth semi-structured interviews by a trained research staff to understand how they responded to their worsening symptoms and decided whether to seek care. 24 caregivers for these Veterans were interviewed about their perspective on the exacerbation event.
In Aim 2, 145 participants from Aim 1 used an inhaler monitor with their albuterol inhaler during the 12-month follow-up period, which transmits real-time data about their daily inhaler use. Data analysis will measure whether a change in albuterol use can predict patient reported COPD exacerbations to determine the appropriate cut-offs that can be used in a future intervention trial.
These aims will provide detailed information on how best to intervene to ensure prompt identification and treatment of COPD exacerbations. New health care delivery approaches will assist Veterans in early identification of exacerbations and provide early access to care that can be integrated into the VA primary care, emergency medicine and pulmonary specialty care settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Other: This is an observational study without an interventionVeterans with COPD who are cared for at VA Puget Sound Health Care System (Seattle, WA) or VA Eastern Colorado (Denver, CO) who are at high risk for a COPD exacerbation based on an exacerbation treated with prednisone or antibiotics in the year preceding enrollment. |
| Informal Caregiver for COPD patients | – | Other: This is an observational study without an interventionInformal caregiver (ie. family member, friend, etc.) for the patient with COPD who is participating in the COPD patients cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic obstructive pulmonary disease (COPD) who receive care at the VA Puget Sound Health Care System in Seattle, WA or the VA Eastern Colorado Health Care System in Denver, CO. Informal caregivers (ie. family member or friend) to the Veteran subject will also be included
Key inclusion criteria (9 listed)
- COPD diagnosis
- Spirometry showing FEV1/VC<0.70
- COPD exacerbation treated with prednisone and/or antibiotics, or that resulted in a visit to the emergency department or hospitalization in the previous 12 months
- English speaking
- Access to telephone
Key exclusion criteria (4 listed)
- nursing home resident
- institutionalized, imprisoned
- life expectancy < 1 year
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 |
|---|---|---|
| This is an observational study without an interventionNot applicable. This is an observational study without an intervention. | Other | COPD patients, Informal Caregiver for COPD patients |
Primary outcome
Decision to seek care
Time frame: Determined for each exacerbation event during the 1-year follow-up period
All participants with at least one exacerbation will be included in this analysis. Individuals could have both treated or untreated exacerbations and the unit of analysis will be each patient-exacerbation event. The outcome will be whether the patient sought treatment (yes/no) for their COPD exacerbation.
1 secondary outcome
Treatment delay
Time frame: Determined for each treated exacerbation event during the 1-year follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Derived from this study: PubMed 37966313Locke ER, Thomas RM, Simpson TL, Fortney JC, Battaglia C, Trivedi RB, Gylys-Colwell J, Swenson ER, Edelman JD, Fan VS. Cognitive and Emotional Responses to Chronic Obstructive Pulmonary Disease Exacerbations and Patterns of Care Seeking. Ann Am Thorac Soc. 2024 Apr;21(4):559-567. doi: 10.1513/AnnalsATS.202303-287OC.
- Derived from this study: PubMed 35169140Locke ER, Young JP, Battaglia C, Simpson TL, Trivedi R, Simons C, Fortney JC, Hebert P, Swenson ER, Edelman J, Fan VS. Care-seeking and delay of care during COPD exacerbations. NPJ Prim Care Respir Med. 2022 Feb 15;32(1):7. doi: 10.1038/s41533-022-00269-9.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by VA Puget Sound Health Care System.
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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Decision to seek care (time frame: Determined for each exacerbation event during the 1-year follow-up period). 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 NCT02725294, which also lists 2 linked publications.
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 2 Apr 2019.