COPDACHIEVENCT03856879
High-quality COPD Care for People With Immune Dysfunction Through Proactive E-consults
A study testing Proactive E-consult in people with COPD and HIV/AIDS, run by Seattle Institute for Biomedical and Clinical Research at 7 sites in United States.
Trial summary
This study examines an intervention to promote effective, evidence-based care and de-implement inappropriate therapies for COPD in HIV-infected (HIV+) patients. The intervention facilitates specialist support of primary care, which includes infectious disease (ID) physicians who serve as the primary care providers… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- What is being tested?
- Proactive E-consult
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 May 2019to 31 May 2025
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providers:
- Outpatient infectious disease providers at one of the seven local sites participating in this study.
- Patients:
- HIV+ patients with COPD treated by providers enrolled in the study.
Who cannot join
- Providers:
- Trainees
- Patients:
- Significant cognitive dysfunction, language barriers or severe psychiatric disorder, impairing ability to participate in surveys and interviews.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Atlanta VA Health Care System
Atlanta, Georgia, 30033
VA Eastern Colorado Health Care System
Denver, Colorado, 80012
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Nashville VA Medical Center
Nashville, Tennessee, 37212
VA Connecticut Healthcare System
New Haven, Connecticut, 06111
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
About this study
Official title: AdvanCing High-quality COPD Care for People With Immune Dysfunction by Implementing EVidence-based Management Through Proactive E-consults
This study examines an intervention to promote effective, evidence-based care and de-implement inappropriate therapies for COPD in HIV-infected (HIV+) patients. The intervention facilitates specialist support of primary care, which includes infectious disease (ID) physicians who serve as the primary care providers (PCP) for their HIV+ patients in the ID clinic. Rather than relying on referral-driven specialty care which may be a barrier to access, pulmonologists will proactively support ID providers to manage a population of HIV+ patients with COPD, delivering real-time evidence-based recommendations tailored to the individual HIV+ patient in the form of an E-consult.
Read the detailed description
Emerging data support that barriers to high quality COPD care are likely accentuated in HIV+ persons. Taken together, decreased recognition of smoking, lack of referral for pulmonary evaluation, worse symptoms and greater exacerbation rates point towards low quality of care for COPD in HIV+ patients. Our preliminary data supports that COPD is inadequately managed in HIV+ patients. These data demonstrate that current management of COPD in HIV+ patients do not adhere to guidelines, that ICS may be over-prescribed and long-acting bronchodilators under-utilized, and support the need to improve evidence-based COPD care in HIV+ patients. Appropriate use of COPD therapies is particularly important for HIV+ patients, as side effects and toxicities could be more harmful in HIV+ patients, given their concomitant multimorbidity and polypharmacy. In summary, an intervention to improve the evidence-based delivery of COPD care can improve outcomes for HIV+ patients. Benefits may extend beyond COPD-related measures. Appropriate use of COPD controller medications can decrease symptoms and exacerbations, and improve health-related quality of life. Our proposed study to has a high potential to substantially improve the quality of care for COPD and patient-centered outcomes for a large number of HIV+ Veterans.
This study tests an intervention to promote effective, evidence-based care and de-implement inappropriate therapies for COPD in HIV+ patients. The intervention facilitates specialist support of primary care, which includes infectious disease (ID) physicians who serve as the primary care providers (PCP) for their HIV+ patients in the ID clinic. Rather than relying on referral-driven specialty care, which may be a barrier to access, pulmonologists will proactively support ID providers to manage a population of HIV+ patients with COPD, delivering real-time evidence-based recommendations tailored to the individual HIV+ patient. The investigators will leverage the Department of Veterans Affairs (VA) clinical and informatics infrastructures to communicate between intervention-team members developing the recommendations (using VA Extension for Community Health Outcomes [ECHO]) and to patients' clinical providers through the electronic health record (EHR) as an E-consult. To limit the burden on the provider, the intervention team will draft recommendations as preliminary orders for providers to review. To preserve their autonomy, the provider has the discretion to endorse (sign), modify or cancel the orders.
This study uses a two-arm cluster randomized controlled trial intervention design grounded in the chronic care model with outcomes evaluated using the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework. The investigators will evaluate barriers and facilitators of optimal COPD care for HIV+ patients, and of effective adoption, implementation and maintenance of the proactive E-consult program, guided by the Consolidated Framework for Implementation Research (CFIR).
This study involves the recruitment and enrollment of two populations: providers and patients. Providers will be recruited at the beginning of the study; providers that enroll will be randomly chosen to either provide usual care (control) or to receive E-consults for their HIV+ patients with COPD (intervention). Patients of enrolled providers will be recruited after attending an appointment with their provider. Enrolled patients will be asked to complete a set of surveys, and some patients will be offered the opportunity to participate in an interview about their care.
- Being tested
- Proactive E-consult
- Keywords
- Chronic obstructive pulmonary disease, intervention studies, randomized controlled trial, provider satisfaction, patient satisfaction, E-consult
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Acquired Immunodeficiency Syndrome, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive E-consultBehavioural
E-consult recommendations and orders will be developed by a panel of pulmonologists and will address a range of care elements for patients with COPD.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Providers in this arm will provide usual care to their HIV+ patients with COPD. |
| Proactive E-consult | Experimental | Providers in this arm will receive proactive E-consults with expert recommendations for COPD care prior to appointments with HIV+ patients with COPD. Receives: Behavioral: Proactive E-consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of COPD care recommendations received by patients of enrolled providers
% of COPD care recommendations received by the patient, examined collectively for each patient and individually by type of recommendation (e.g. use of spirometry, long acting bronchodilator, smoking cessation, vaccination, etc.) to assess the overall quality of COPD care.
Measured: 6 months following provider/patient appointment
Secondary outcomes (1)
Patient health-related quality of life
Patient-reported health-related quality of life on the Medical Outcomes 12-item short form (SF-12), a patient self-report survey. This survey is a 12-item scale with two subscales (mental and physical components). Summary scores range from 0-100, with higher scores reflecting better health.
Measured: 6 weeks following provider/patient appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start21 May 2019
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Providers will be randomly assigned to the intervention or control group, stratified by site, provider type and panel size.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Washington D.C. Veterans Affairs Medical Center, VA Eastern Colorado Health Care System, University of Colorado, Denver, VA Greater Los Angeles Healthcare System, Atlanta VA Medical Center, Yale University, VA Connecticut Healthcare System, Corporal Michael J. Crescenz VA Medical Center, VA Tennessee Valley Health Care System
- Responsible party
- Sponsor
- Investigators
- David H. Au, MD, MS, Principal investigator, VA Puget Sound Health Care SystemKristina A. Crothers, MD, Principal investigator, VA Puget Sound Health Care SystemChristian D. Helfrich, PhD, MPH, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856879
- Sponsor's protocol ID
- 1U01HL142103-01
- Acronym
- ACHIEVE
- Status last verified
- Jun 2025
- First submitted
- 20 Feb 2019
- Last updated
- 30 Jul 2025
- 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AdvanCing High-quality COPD Care for People With Immune Dysfunction by Implementing EVidence-based Management Through Proactive E-consults
- ClinicalTrials.gov ID
- NCT03856879
- Acronym / sponsor ID
- ACHIEVE / 1U01HL142103-01
- Keywords
- Chronic obstructive pulmonary disease, intervention studies, randomized controlled trial, provider satisfaction, patient satisfaction, E-consult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Washington D.C. Veterans Affairs Medical Center, VA Eastern Colorado Health Care System, University of Colorado, Denver, VA Greater Los Angeles Healthcare System, Atlanta VA Medical Center, Yale University, VA Connecticut Healthcare System, Corporal Michael J. Crescenz VA Medical Center, VA Tennessee Valley Health Care System
- Study start
- 21 May 2019 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 27 Feb 2019 (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 study examines an intervention to promote effective, evidence-based care and de-implement inappropriate therapies for COPD in HIV-infected (HIV+) patients. The intervention facilitates specialist support of primary care, which includes infectious disease (ID) physicians who serve as the primary care providers (PCP) for their HIV+ patients in the ID clinic. Rather than relying on referral-driven specialty care which may be a barrier to access, pulmonologists will proactively support ID providers to manage a population of HIV+ patients with COPD, delivering real-time evidence-based recommendations tailored to the individual HIV+ patient in the form of an E-consult.
Detailed description
Emerging data support that barriers to high quality COPD care are likely accentuated in HIV+ persons. Taken together, decreased recognition of smoking, lack of referral for pulmonary evaluation, worse symptoms and greater exacerbation rates point towards low quality of care for COPD in HIV+ patients. Our preliminary data supports that COPD is inadequately managed in HIV+ patients. These data demonstrate that current management of COPD in HIV+ patients do not adhere to guidelines, that ICS may be over-prescribed and long-acting bronchodilators under-utilized, and support the need to improve evidence-based COPD care in HIV+ patients. Appropriate use of COPD therapies is particularly important for HIV+ patients, as side effects and toxicities could be more harmful in HIV+ patients, given their concomitant multimorbidity and polypharmacy. In summary, an intervention to improve the evidence-based delivery of COPD care can improve outcomes for HIV+ patients. Benefits may extend beyond COPD-related measures. Appropriate use of COPD controller medications can decrease symptoms and exacerbations, and improve health-related quality of life. Our proposed study to has a high potential to substantially improve the quality of care for COPD and patient-centered outcomes for a large number of HIV+ Veterans.
This study tests an intervention to promote effective, evidence-based care and de-implement inappropriate therapies for COPD in HIV+ patients. The intervention facilitates specialist support of primary care, which includes infectious disease (ID) physicians who serve as the primary care providers (PCP) for their HIV+ patients in the ID clinic. Rather than relying on referral-driven specialty care, which may be a barrier to access, pulmonologists will proactively support ID providers to manage a population of HIV+ patients with COPD, delivering real-time evidence-based recommendations tailored to the individual HIV+ patient. The investigators will leverage the Department of Veterans Affairs (VA) clinical and informatics infrastructures to communicate between intervention-team members developing the recommendations (using VA Extension for Community Health Outcomes [ECHO]) and to patients' clinical providers through the electronic health record (EHR) as an E-consult. To limit the burden on the provider, the intervention team will draft recommendations as preliminary orders for providers to review. To preserve their autonomy, the provider has the discretion to endorse (sign), modify or cancel the orders.
This study uses a two-arm cluster randomized controlled trial intervention design grounded in the chronic care model with outcomes evaluated using the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework. The investigators will evaluate barriers and facilitators of optimal COPD care for HIV+ patients, and of effective adoption, implementation and maintenance of the proactive E-consult program, guided by the Consolidated Framework for Implementation Research (CFIR).
This study involves the recruitment and enrollment of two populations: providers and patients. Providers will be recruited at the beginning of the study; providers that enroll will be randomly chosen to either provide usual care (control) or to receive E-consults for their HIV+ patients with COPD (intervention). Patients of enrolled providers will be recruited after attending an appointment with their provider. Enrolled patients will be asked to complete a set of surveys, and some patients will be offered the opportunity to participate in an interview about their care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Providers will be randomly assigned to the intervention or control group, stratified by site, provider type and panel size.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Providers in this arm will provide usual care to their HIV+ patients with COPD. |
| Proactive E-consult | Experimental | Behavioral: Proactive E-consultProviders in this arm will receive proactive E-consults with expert recommendations for COPD care prior to appointments with HIV+ patients with COPD. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatient infectious disease providers at one of the seven local sites participating in this study.
- HIV+ patients with COPD treated by providers enrolled in the study.
Key exclusion criteria (4 listed)
- Trainees
- Significant cognitive dysfunction, language barriers or severe psychiatric disorder, impairing ability to participate in surveys and interviews.
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 |
|---|---|---|
| Proactive E-consultE-consult recommendations and orders will be developed by a panel of pulmonologists and will address a range of care elements for patients with COPD. | Behavioural | Proactive E-consult |
Primary outcome
% of COPD care recommendations received by patients of enrolled providers
Time frame: 6 months following provider/patient appointment
% of COPD care recommendations received by the patient, examined collectively for each patient and individually by type of recommendation (e.g. use of spirometry, long acting bronchodilator, smoking cessation, vaccination, etc.) to assess the overall quality of COPD care.
1 secondary outcome
Patient health-related quality of life
Time frame: 6 weeks following provider/patient appointment
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 30 Jul 2025.
- 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.
David H. Au, MD, MS principal investigator
VA Puget Sound Health Care System
Kristina A. Crothers, MD principal investigator
VA Puget Sound Health Care System
Christian D. Helfrich, PhD, MPH principal investigator
VA Puget Sound Health Care System
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive E-consult in people with COPD and HIV/AIDS, run by Seattle Institute for Biomedical and Clinical Research at 7 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 4 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: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
% of COPD care recommendations received by patients of enrolled providers (time frame: 6 months following provider/patient appointment). 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 30 Jul 2025; AzTrials last refreshed its copy on 27 Oct 2026.