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

Primary Purpose

COPD, HIV/AIDS

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proactive E-consult
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COPD focused on measuring Chronic obstructive pulmonary disease, intervention studies, randomized controlled trial, provider satisfaction, patient satisfaction, E-consult

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Greater Los Angeles Healthcare System
  • VA Eastern Colorado Health Care System
  • VA Connecticut Healthcare System
  • Washington DC VA Medical Center
  • Atlanta VA Health Care System
  • Philadelphia VA Medical Center
  • Nashville VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Proactive E-consult

Arm Description

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

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

Outcomes

Primary Outcome Measures

% 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.

Secondary Outcome Measures

Patient health-related quality of life
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.

Full Information

First Posted
February 20, 2019
Last Updated
August 16, 2023
Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
VA Puget Sound Health Care System, Washington D.C. Veterans Affairs Medical Center, VA Eastern Colorado Health Care System, University of Colorado, Denver, VA Greater Los Angeles Healthcare System, Atlanta VA Medical Center, Yale University, VA Connecticut Healthcare System, Corporal Michael J. Crescenz VA Medical Center, Nashville VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03856879
Brief Title
High-quality COPD Care for People With Immune Dysfunction Through Proactive E-consults
Acronym
ACHIEVE
Official Title
AdvanCing High-quality COPD Care for People With Immune Dysfunction by Implementing EVidence-based Management Through Proactive E-consults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
VA Puget Sound Health Care System, Washington D.C. Veterans Affairs Medical Center, VA Eastern Colorado Health Care System, University of Colorado, Denver, VA Greater Los Angeles Healthcare System, Atlanta VA Medical Center, Yale University, VA Connecticut Healthcare System, Corporal Michael J. Crescenz VA Medical Center, Nashville VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, HIV/AIDS
Keywords
Chronic obstructive pulmonary disease, intervention studies, randomized controlled trial, provider satisfaction, patient satisfaction, E-consult

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Providers will be randomly assigned to the intervention or control group, stratified by site, provider type and panel size.
Masking
Outcomes Assessor
Masking Description
Study staff conducting patient surveys and evaluating quality of COPD care will be blinded to intervention/control assignment of the patient's provider.
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Providers in this arm will provide usual care to their HIV+ patients with COPD.
Arm Title
Proactive E-consult
Arm Type
Experimental
Arm Description
Providers in this arm will receive proactive E-consults with expert recommendations for COPD care prior to appointments with HIV+ patients with COPD.
Intervention Type
Behavioral
Intervention Name(s)
Proactive E-consult
Intervention Description
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.
Primary Outcome Measure Information:
Title
% of COPD care recommendations received by patients of enrolled providers
Description
% 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.
Time Frame
6 months following provider/patient appointment
Secondary Outcome Measure Information:
Title
Patient health-related quality of life
Description
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.
Time Frame
6 weeks following provider/patient appointment
Other Pre-specified Outcome Measures:
Title
HIV provider satisfaction with specialty-care support
Description
Baseline and follow-up self-report surveys (all participating providers) and interviews (sample of providers)
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H. Au, MD, MS
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristina A. Crothers, MD
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian D. Helfrich, PhD, MPH
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
VA Eastern Colorado Health Care System
City
Denver
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
VA Connecticut Healthcare System
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06111
Country
United States
Facility Name
Washington DC VA Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Atlanta VA Health Care System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Philadelphia VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Nashville VA Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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