Proactive E-consults for COPD in HIV/AIDS Patients

(ACHIEVE Trial)

No longer recruiting at 8 trial locations

Overseen By John R Kundzins, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Institute for Biomedical and Clinical Research

Disqualifiers: Cognitive dysfunction, Language barriers, Psychiatric disorder

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for people with COPD, a lung disease causing breathing problems, who also have HIV. It tests a system where lung specialists provide real-time advice to HIV doctors through electronic consultations (E-consults). Participants are divided into two groups: one receiving proactive E-consults and the other receiving usual care. Suitable candidates for the trial are HIV-positive individuals with COPD who are treated by their regular HIV doctor. As an unphased trial, this study offers a unique opportunity to enhance care by integrating specialist advice into regular treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for HIV+ patients with COPD?

Research has shown that electronic consultations (e-consults) hold promise for improving COPD care in patients with HIV. While specific safety details are not provided, e-consults generally pose low risk, as they focus on communication and advice rather than direct medical procedures.

Previous studies have found that e-consults enhance healthcare by offering timely, evidence-based advice, making them user-friendly for both patients and healthcare providers. No major issues have been reported directly from using e-consults for managing COPD care.

This approach leverages existing technology to enhance communication between specialists and primary care providers, suggesting it is safe for participants. However, like any new care method, it requires ongoing monitoring and feedback to ensure continued safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Proactive E-consult approach for COPD in HIV/AIDS patients because it leverages expert recommendations tailored to each patient before their doctor visits. Unlike the usual care, which relies on standard protocols, this method aims to enhance personalized care by integrating specialist insights directly into the treatment plan. By potentially improving communication and decision-making between general providers and specialists, it could lead to more effective management of COPD symptoms in this vulnerable population.

What evidence suggests that proactive E-consults are effective for COPD in HIV+ patients?

Research has shown that proactive online consultations can improve care for COPD (a lung disease that makes breathing difficult) in people living with HIV. In this trial, some providers will receive proactive E-consults with expert recommendations for COPD care before appointments with HIV+ patients with COPD. Specifically, patients who received this support had better outcomes after hospital visits for COPD. In these cases, expert advice helped primary care doctors make quick, informed decisions. This proactive approach allowed doctors to provide personalized care tailored to each patient’s needs. Primary care providers also found this method practical and acceptable. Overall, proactive online consultations have shown promise in improving COPD management for those living with HIV. ^{1 2 4 6 7}

Who Is on the Research Team?

Christian D. Helfrich, PhD, MPH

Principal Investigator

VA Puget Sound Health Care System

Kristina A Crothers, MD

Principal Investigator

VA Puget Sound Health Care System

David H Au, MD, MS

Principal Investigator

VA Puget Sound Health Care System

Are You a Good Fit for This Trial?

This trial is for HIV+ patients with Chronic Obstructive Pulmonary Disease (COPD) who are treated by outpatient infectious disease providers at one of the seven local sites in this study. It excludes those with significant cognitive dysfunction, language barriers, or severe psychiatric disorders that impair survey and interview participation.

Inclusion Criteria

Patients: HIV+ patients with COPD treated by providers enrolled in the study.

Providers: Outpatient infectious disease providers at one of the seven local sites participating in this study.

Exclusion Criteria

Providers: Trainees

I do not have severe mental health issues that would prevent me from understanding or participating in surveys and interviews.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Providers receive proactive E-consults with expert recommendations for COPD care prior to appointments with HIV+ patients with COPD

6 months

E-consults provided prior to patient appointments

Follow-up

Participants are monitored for satisfaction and quality of care after receiving E-consults

up to 3 years

Baseline and follow-up surveys and interviews

What Are the Treatments Tested in This Trial?

Interventions

• Proactive E-consult

Trial Overview The study tests a proactive E-consult system where pulmonologists give real-time, tailored advice to infectious disease physicians managing HIV+ patients with COPD. This aims to improve care quality without relying on traditional referrals.

How Is the Trial Designed?

Group I: Proactive E-consult Experimental Treatment 1 Intervention

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

Group II: Usual care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

Trials

55

Recruited

13,700+

VA Tennessee Valley Health Care System

Collaborator

Trials

5

Recruited

1,400+

VA Puget Sound Health Care System

Collaborator

Trials

67

Recruited

225,000+

Washington D.C. Veterans Affairs Medical Center

Collaborator

Trials

45

Recruited

18,500+

VA Eastern Colorado Health Care System

Collaborator

Trials

55

Recruited

26,200+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Corporal Michael J. Crescenz VA Medical Center

Collaborator

Trials

31

Recruited

9,900+

VA Connecticut Healthcare System

Collaborator

Trials

86

Recruited

8,800+

Nashville VA Medical Center

Collaborator

Trials

4

Recruited

770+

VA Greater Los Angeles Healthcare System

Collaborator

Trials

53

Recruited

8,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10528346/

Design and methods of a randomized trial testing ... A randomized trial testing Advancing Care for COPD in People Living with HIV by Implementing Evidence-Based Management Through Proactive E-consults (ACHIEVE)

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03856879

Study Details | NCT03856879 | High-quality COPD Care ... This study examines an intervention to promote effective, evidence-based care and de-implement inappropriate therapies for COPD in HIV-infected (HIV+) patients.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36472622/

Primary Care Provider Experience With Proactive E- ... We tested a novel intervention, INtegrating Care After Exacerbation of COPD (InCasE), that improved patient outcomes after hospitalization for COPD.

4. researchgate.net researchgate.net/publication/372536902_Design_and_methods_of_a_randomized_trial_testing_advancing_care_for_COPD_in_people_living_with_HIV_by_implementing_evidence-based_management_through_proactive_E-consults_ACHIEVE

Design and methods of a randomized trial testing ... To address this gap, we are conducting the study, "Advancing care for COPD in people living with HIV by Implementing Evidence-based management ...

5. journal.copdfoundation.org journal.copdfoundation.org/jcopdf/id/1413/Primary-Care-Provider-Experience-With-Proactive-E-Consults-to-Improve-COPD-Outcomes-and-Access-to-Specialty-Care

Proactive Pulmonary E-Consult Acceptable for Primary Care Key Results: We conducted 10 interviews and 37 PCPs completed surveys. PCPs perceived InCasE to be acceptable and feasible. Facilitators included the proactive ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425001557

Protocol for a pragmatic trial to enhance quality safety, and ... Among these, high-quality evidence shows that proactive electronic consultations to primary care providers can improve COPD care quality and ...

7. jmir.org jmir.org/2022/8/e38663

Proactive Electronic Visits for Smoking Cessation and ... The purpose of this study was to preliminarily evaluate an integrated asynchronous smoking cessation and COPD screening e-visit (electronic ...