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INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03687060
Recruitment Status : Active, not recruiting
First Posted : September 27, 2018
Last Update Posted : January 21, 2022
Sponsor:
Collaborators:
RAND
Olive View-UCLA Education & Research Institute
Information provided by (Responsible Party):
Allison L. Diamant, University of California, Los Angeles

Study Description
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Brief Summary:
Cardiovascular disease is a major cause of morbidity and mortality among people living with HIV. Recent studies have demonstrated that patients with HIV experience a 50-100% increased risk of myocardial infarction and stroke compared to HIV-uninfected persons. They also face higher risks of stroke, sudden death, and heart failure. However, evidence-based statin therapy-which is safe in this population and highly effective at reducing cardiovascular risk-is under-prescribed. The investigators propose a multi-level intervention to increase evidence-based statin prescribing by addressing barriers at these levels. The implementation intervention includes two strategies: (1) tailored education at the leadership, provider, and patient levels, and (2) behavioral economics-informed feedback for providers.

Condition or disease Intervention/treatment Phase
HIV Cardiovascular Diseases Behavioral: Knowledge assessment Behavioral: Education Intervention Behavioral: Provider Feedback Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Stepped-wedge cluster randomized trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Behavioral Economics and Implementation Research to Reduce Cardiovascular Risk in HIV-Infected Adults
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Organization Level Behavioral: Knowledge assessment
Investigators will conduct semi-structured interviews with medical directors, clinical leadership and all participating physicians to gain insight on knowledge about and barriers to prescribing statins for people living with HIV. People living with HIV will participate in focus groups.
Provider Level Behavioral: Knowledge assessment
Investigators will conduct semi-structured interviews with medical directors, clinical leadership and all participating physicians to gain insight on knowledge about and barriers to prescribing statins for people living with HIV. People living with HIV will participate in focus groups.

Behavioral: Education Intervention

Education intervention will be adapted from the the findings of these interviews and focus groups.

Clinics will be randomized to receive the "education intervention and feedback" implementation strategies at different times.

Medical directors and providers will receive a brief educational intervention about cardiovascular disease risk in people living with HIV. Providers will additionally receive a web-based survey before and after the education intervention.

Patients will receive pamphlets tailored to the effects of cardiovascular disease treatment for people living with HIV.


Behavioral: Provider Feedback
Six months after the education intervention, providers will receive monthly emails with feedback regarding their rates of prescribing statins, with language targeted at increasing motivation to prescribe by leveraging social norms and self-image.
Patient Level Behavioral: Knowledge assessment
Investigators will conduct semi-structured interviews with medical directors, clinical leadership and all participating physicians to gain insight on knowledge about and barriers to prescribing statins for people living with HIV. People living with HIV will participate in focus groups.


Outcome Measures
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Primary Outcome Measures :
  1. Change in proportion of PLWH with cardiovascular risk factors seen by a physician receiving statin therapy [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 40 years
  • have been diagnosed with HIV
  • LDL ≥ 190, diabetes and LDL ≥ 70
  • or 10-year ASCVD risk ≥ 7.5%
  • or history of heart attack, stroke, or peripheral vascular disease
  • care for patients with HIV at least 1/2 day each week (physicians)
  • work at participating clinics (physicians)

Exclusion Criteria:

  • unable to provide written, informed consent
  • not at participating clinic
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687060


Locations
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United States, California
JWCH Institute
Commerce, California, United States, 90040
Antelope Valley Health Center
Lancaster, California, United States, 93535
Watts Health Center
Los Angeles, California, United States, 90002
Oasis Clinic
Los Angeles, California, United States, 90059
To Help Everyone Health and Wellness Centers
Los Angeles, California, United States, 90062
Venice Family Clinic
Santa Monica, California, United States, 90405
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342
Tarzana Treatment Centers, Inc.
Tarzana, California, United States, 91356
Sponsors and Collaborators
University of California, Los Angeles
RAND
Olive View-UCLA Education & Research Institute
Investigators
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Principal Investigator: Joseph Ladapo, MD, PhD University of California, Los Angeles
Principal Investigator: William Cunningham, MD, MPH University of California, Los Angeles
More Information
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Publications:

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Responsible Party: Allison L. Diamant, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03687060    
Other Study ID Numbers: 1U01HL142104-01 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases