INcreasing Statin Prescribing in HIV Behavioral Economics REsearch

NCT03687060 | Unknown

• 1 other identifier: 1U01HL142104-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 8

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.

Conditions

HIV; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in proportion of PLWH with cardiovascular risk factors seen by a physician receiving statin therapy

  12 months

Study Arms (3)

Organization Level

OTHER

Behavioral: Knowledge assessment

Provider Level

OTHER

Behavioral: Knowledge assessment; Behavioral: Education Intervention; Behavioral: Provider Feedback

Patient Level

OTHER

Behavioral: Knowledge assessment

Interventions

Knowledge assessment BEHAVIORAL

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.

Organization Level; Patient Level; Provider Level

Education Intervention BEHAVIORAL

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.

Provider Level

Provider Feedback BEHAVIORAL

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.

Provider Level

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• unable to provide written, informed consent
• not at participating clinic

Sponsors & Collaborators

• University of California, Los Angeles: lead
• RAND: collaborator
• Olive View-UCLA Education & Research Institute: collaborator

Study Sites (8)

JWCH Institute

Commerce, California, 90040, United States

Location

Antelope Valley Health Center

Lancaster, California, 93535, United States

Location

Watts Health Center

Los Angeles, California, 90002, United States

Location

Oasis Clinic

Los Angeles, California, 90059, United States

Location

To Help Everyone Health and Wellness Centers

Los Angeles, California, 90062, United States

Location

Venice Family Clinic

Santa Monica, California, 90405, United States

Location

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

Tarzana Treatment Centers, Inc.

Tarzana, California, 91356, United States

Location

Related Publications (19)

• Feinstein MJ, Bahiru E, Achenbach C, Longenecker CT, Hsue P, So-Armah K, Freiberg MS, Lloyd-Jones DM. Patterns of Cardiovascular Mortality for HIV-Infected Adults in the United States: 1999 to 2013. Am J Cardiol. 2016 Jan 15;117(2):214-20. doi: 10.1016/j.amjcard.2015.10.030. Epub 2015 Nov 6.

  PMID: 26639041 BACKGROUND

• Aberg JA, Sponseller CA, Ward DJ, Kryzhanovski VA, Campbell SE, Thompson MA. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised, double-blind, superiority trial. Lancet HIV. 2017 Jul;4(7):e284-e294. doi: 10.1016/S2352-3018(17)30075-9. Epub 2017 Apr 13.

  PMID: 28416195 BACKGROUND

• Masia M, Bernal E, Robledano C, Padilla S, Lopez N, Martinez E, Gutierrez F. Long-term effects of an intensive intervention in HIV-infected patients with moderate-high atherosclerotic cardiovascular risk. J Antimicrob Chemother. 2014 Nov;69(11):3051-6. doi: 10.1093/jac/dku269. Epub 2014 Jul 18.

  PMID: 25038306 BACKGROUND

• Freiberg MS, Chang CC, Kuller LH, Skanderson M, Lowy E, Kraemer KL, Butt AA, Bidwell Goetz M, Leaf D, Oursler KA, Rimland D, Rodriguez Barradas M, Brown S, Gibert C, McGinnis K, Crothers K, Sico J, Crane H, Warner A, Gottlieb S, Gottdiener J, Tracy RP, Budoff M, Watson C, Armah KA, Doebler D, Bryant K, Justice AC. HIV infection and the risk of acute myocardial infarction. JAMA Intern Med. 2013 Apr 22;173(8):614-22. doi: 10.1001/jamainternmed.2013.3728.

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  PMID: 27398770 BACKGROUND

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  PMID: 27613562 BACKGROUND

• Ladapo JA, Richards AK, DeWitt CM, Harawa NT, Shoptaw S, Cunningham WE, Mafi JN. Disparities in the Quality of Cardiovascular Care Between HIV-Infected Versus HIV-Uninfected Adults in the United States: A Cross-Sectional Study. J Am Heart Assoc. 2017 Nov 14;6(11):e007107. doi: 10.1161/JAHA.117.007107.

  PMID: 29138182 BACKGROUND

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  PMID: 18728716 BACKGROUND

• Lubloy A. Factors affecting the uptake of new medicines: a systematic literature review. BMC Health Serv Res. 2014 Oct 20;14:469. doi: 10.1186/1472-6963-14-469.

  PMID: 25331607 BACKGROUND

• Doroodchi H, Abdolrasulnia M, Foster JA, Foster E, Turakhia MP, Skelding KA, Sagar K, Casebeer LL. Knowledge and attitudes of primary care physicians in the management of patients at risk for cardiovascular events. BMC Fam Pract. 2008 Jul 8;9:42. doi: 10.1186/1471-2296-9-42.

  PMID: 18611255 BACKGROUND

• Trinkley KE, Malone DC, Nelson JA, Saseen JJ. Prescribing attitudes, behaviors and opinions regarding metformin for patients with diabetes: a focus group study. Ther Adv Chronic Dis. 2016 Sep;7(5):220-8. doi: 10.1177/2040622316657328. Epub 2016 Aug 11.

  PMID: 27583122 BACKGROUND

• Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding Statin Use in America and Gaps in Patient Education (USAGE): an internet-based survey of 10,138 current and former statin users. J Clin Lipidol. 2012 May-Jun;6(3):208-15. doi: 10.1016/j.jacl.2012.03.003.

  PMID: 22658145 BACKGROUND

• Fung V, Sinclair F, Wang H, Dailey D, Hsu J, Shaber R. Patients' perspectives on nonadherence to statin therapy: a focus-group study. Perm J. 2010 Spring;14(1):4-10. doi: 10.7812/tpp/09-090.

  PMID: 20740125 BACKGROUND

• Wei MY, Ito MK, Cohen JD, Brinton EA, Jacobson TA. Predictors of statin adherence, switching, and discontinuation in the USAGE survey: understanding the use of statins in America and gaps in patient education. J Clin Lipidol. 2013 Sep-Oct;7(5):472-83. doi: 10.1016/j.jacl.2013.03.001. Epub 2013 Mar 13.

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• Aarons GA. Mental health provider attitudes toward adoption of evidence-based practice: the Evidence-Based Practice Attitude Scale (EBPAS). Ment Health Serv Res. 2004 Jun;6(2):61-74. doi: 10.1023/b:mhsr.0000024351.12294.65.

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MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Allison Diamant, MD, MSHS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• William Cunningham, MD, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stepped-wedge cluster randomized trial

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 27, 2018
• Study Start: March 4, 2019
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)