INSPIRE: INcreasing Statin Prescribing in HIV Behavioral Economics REsearch

Sponsor

University of California, Los Angeles (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03687060

Collaborator

RAND (Other), Olive View-UCLA Education & Research Institute (Other)

Enrollment

Locations

Arms

47.9

Anticipated Duration (Months)

9.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Stepped-wedge cluster randomized trialStepped-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 :

Mar 4, 2019

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Other: Provider Level

Behavioral: Knowledge assessment

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.

Other: Patient Level

Behavioral: Knowledge assessment

Outcome Measures

Primary Outcome Measures

Change in proportion of PLWH with cardiovascular risk factors seen by a physician receiving statin therapy [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	JWCH Institute	Commerce	California	United States	90040
2	Antelope Valley Health Center	Lancaster	California	United States	93535
3	Watts Health Center	Los Angeles	California	United States	90002
4	Oasis Clinic	Los Angeles	California	United States	90059
5	To Help Everyone Health and Wellness Centers	Los Angeles	California	United States	90062
6	Venice Family Clinic	Santa Monica	California	United States	90405
7	Olive View-UCLA Medical Center	Sylmar	California	United States	91342
8	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

Principal Investigator: Joseph Ladapo, MD, PhD, University of California, Los Angeles
Principal Investigator: William Cunningham, MD, MPH, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Allison L. Diamant, Principal Investigator, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT03687060

Other Study ID Numbers:

1U01HL142104-01

First Posted:

Sep 27, 2018

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Jan 21, 2022