Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03856879 |
| Other study ID # |
1U01HL142103-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 21, 2019 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Seattle Institute for Biomedical and Clinical Research |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 (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.
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.
