Clinical trial NCT03856879: High-quality COPD Care for People With Immune Dysfunction Through Proactive E-consults
Official title: AdvanCing High-quality COPD Care for People With Immune Dysfunction by Implementing EVidence-based Management Through Proactive E-consults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD
HIV/AIDS
Keywords: Chronic obstructive pulmonary disease
intervention studies
randomized controlled trial
provider satisfaction
patient satisfaction
E-consult
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: VA Puget Sound Health Care System
name: Washington D.C. Veterans Affairs Medical Center
name: VA Eastern Colorado Health Care System
name: University of Colorado, Denver
name: VA Greater Los Angeles Healthcare System
name: Atlanta VA Medical Center
name: Yale University
name: VA Connecticut Healthcare System
name: Corporal Michael J. Crescenz VA Medical Center
name: VA Tennessee Valley Health Care System
First posted: 2019-02-27
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Providers will be randomly assigned to the intervention or control group, stratified by site, provider type and panel size.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: % of COPD care recommendations received by patients of enrolled providers
timeFrame: 6 months following provider/patient appointment
Secondary outcomes:
measure: Patient health-related quality of life
timeFrame: 6 weeks following provider/patient appointment
Other outcomes:
measure: HIV provider satisfaction with specialty-care support
timeFrame: 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.
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System
state: Colorado
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
city: Washington, D.C.
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Atlanta VA Health Care System
state: Georgia
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville VA Medical Center
state: Tennessee
Study officials:
affiliation: VA Puget Sound Health Care System
name: David H. Au, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System
name: Kristina A. Crothers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System
name: Christian D. Helfrich, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: