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CompletedNCT03856879ClinicalTrials.gov record

High-quality COPD Care for People With Immune Dysfunction Through Proactive E-consults

COPD · HIV/AIDS

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 89 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
346 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion criteria:

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.

Exclusion Criteria:

Providers:

• Trainees

Patients:

• Significant cognitive dysfunction, language barriers or severe psychiatric disorder, impairing ability to participate in surveys and interviews.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Single masked
Usual care

Providers in this arm will provide usual care to their HIV+ patients with COPD.

Proactive E-consult

Providers in this arm will receive proactive E-consults with expert recommendations for COPD care prior to appointments with HIV+ patients with COPD.

Behavioral: Proactive E-consult

Proactive E-consult BEHAVIORAL

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

% of COPD Care Recommendations Received by Patients of Enrolled Providers

Time frame: Within 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. We will report percentage of actionable care recommendations received by the patient out of the total recommendations sent across all patients, using "Number" as the measure type.

Secondary measures

Patient Health-related Quality of Life

Time frame: 6 weeks following provider/patient appointment

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.

Other measures

HIV Provider Satisfaction With Specialty-care Support

Time frame: Baseline: prior to intervention roll-out. Follow-up: after exposure to intervention (defined as having received at least 2 E-consults), up to 3 years.

Baseline and follow-up self-report surveys (all participating providers) and interviews (sample of providers)

Results are posted in the registry.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (7)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

7 locations

VA Greater Los Angeles Healthcare SystemLos Angeles, California, United StatesStatus unknown
VA Eastern Colorado Health Care SystemDenver, Colorado, United StatesStatus unknown
VA Connecticut Healthcare SystemNew Haven, Connecticut, United StatesStatus unknown
Washington DC VA Medical CenterWashington D.C., District of Columbia, United StatesStatus unknown
Atlanta VA Health Care SystemAtlanta, Georgia, United StatesStatus unknown
Philadelphia VA Medical CenterPhiladelphia, Pennsylvania, United StatesStatus unknown
Nashville VA Medical CenterNashville, Tennessee, United StatesStatus unknown

Study team and timeline

Lead sponsor
Seattle Institute for Biomedical and Clinical Research
Study start
May 21, 2019 Actual
Primary completion
May 31, 2025 Actual
Study completion
May 31, 2025 Actual
First posted
Feb 27, 2019 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

AdvanCing High-quality COPD Care for People With Immune Dysfunction by Implementing EVidence-based Management Through Proactive E-consults

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026