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

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ClinicalTrials.gov Identifier: NCT03856879
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
VA Puget Sound Health Care System
Bronx Veterans Medical Research Foundation, Inc
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
Baylor College of Medicine
Michael Debakey Veterans Affairs Medical Center
Yale University
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE February 27, 2019
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE May 21, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
% of COPD care recommendations received by patients of enrolled providers [ Time Frame: 6 months following provider/patient appointment ]
% 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03856879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
Patient health-related quality of life [ Time Frame: 6 weeks following provider/patient appointment ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 26, 2019)
HIV provider satisfaction with specialty-care support [ 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. ]
Baseline and follow-up self-report surveys (all participating providers) and interviews (sample of providers)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE High-quality COPD Care for People With Immune Dysfunction Through Proactive E-consults
Official Title  ICMJE AdvanCing High-quality COPD Care for People With Immune Dysfunction by Implementing EVidence-based Management Through Proactive E-consults
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Providers will be randomly assigned to the intervention or control group, stratified by site, provider type and panel size.
Masking: Single (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.
Primary Purpose: Health Services Research
Condition  ICMJE
  • COPD
  • HIV/AIDS
Intervention  ICMJE Behavioral: Proactive E-consult
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.
Study Arms  ICMJE
  • No Intervention: Usual care
    Providers in this arm will provide usual care to their HIV+ patients with COPD.
  • Experimental: Proactive E-consult
    Providers in this arm will receive proactive E-consults with expert recommendations for COPD care prior to appointments with HIV+ patients with COPD.
    Intervention: Behavioral: Proactive E-consult
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
504
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Janaki M Torrence, MS 206-277-1548 ext 61548 Janaki.Torrence@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03856879
Other Study ID Numbers  ICMJE 1U01HL142103-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seattle Institute for Biomedical and Clinical Research
Study Sponsor  ICMJE Seattle Institute for Biomedical and Clinical Research
Collaborators  ICMJE
  • VA Puget Sound Health Care System
  • Bronx Veterans Medical Research Foundation, Inc
  • 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
  • Baylor College of Medicine
  • Michael Debakey Veterans Affairs Medical Center
  • Yale University
  • VA Connecticut Healthcare System
Investigators  ICMJE
Principal Investigator: 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
PRS Account Seattle Institute for Biomedical and Clinical Research
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP