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

NCT03856879 | Completed DMC

• 1 other identifier: 1U01HL142103-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 7

Brief 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 (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.

Conditions

COPD; HIV/AIDS

Keywords

Chronic obstructive pulmonary disease; intervention studies; randomized controlled trial; provider satisfaction; patient satisfaction; E-consult

Outcome Measures

Primary Outcomes (1)

• % 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.

  6 months following provider/patient appointment

Secondary Outcomes (1)

• Patient health-related quality of life

  6 weeks following provider/patient appointment

Other Outcomes (1)

• HIV provider satisfaction with specialty-care support

  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.

Study Arms (2)

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.

Behavioral: Proactive E-consult

Interventions

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.

Proactive E-consult

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• VA Puget Sound Health Care System: collaborator
• Washington D.C. Veterans Affairs Medical Center: collaborator
• VA Eastern Colorado Health Care System: collaborator
• University of Colorado, Denver: collaborator
• VA Greater Los Angeles Healthcare System: collaborator
• Atlanta VA Medical Center: collaborator
• Yale University: collaborator
• VA Connecticut Healthcare System: collaborator
• Corporal Michael J. Crescenz VA Medical Center: collaborator
• VA Tennessee Valley Health Care System: collaborator

Study Sites (7)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

VA Eastern Colorado Health Care System

Denver, Colorado, 80012, United States

Location

VA Connecticut Healthcare System

New Haven, Connecticut, 06111, United States

Location

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Atlanta VA Health Care System

Atlanta, Georgia, 30033, United States

Location

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Nashville VA Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Acquired Immunodeficiency Syndrome; Patient Satisfaction

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• David H. Au, MD, MS

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

• Kristina A. Crothers, MD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

• Christian D. Helfrich, PhD, MPH

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study staff conducting patient surveys and evaluating quality of COPD care will be blinded to intervention/control assignment of the patient's provider.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Providers will be randomly assigned to the intervention or control group, stratified by site, provider type and panel size.

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 27, 2019
• Study Start: May 21, 2019
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)