INcreasing Statin Prescribing in HIV Behavioral Economics REsearch
NCT ID: NCT03687060
Last Updated: 2023-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2019-03-04
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Organization Level
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
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.
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.
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
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* not at participating clinic
40 Years
ALL
No
Sponsors
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RAND
OTHER
Olive View-UCLA Education & Research Institute
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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Allison L. Diamant
Principal Investigator
Principal Investigators
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Allison Diamant, MD, MSHS
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
William Cunningham, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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JWCH Institute
Commerce, California, United States
Antelope Valley Health Center
Lancaster, California, United States
Watts Health Center
Los Angeles, California, United States
Oasis Clinic
Los Angeles, California, United States
To Help Everyone Health and Wellness Centers
Los Angeles, California, United States
Venice Family Clinic
Santa Monica, California, United States
Olive View-UCLA Medical Center
Sylmar, California, United States
Tarzana Treatment Centers, Inc.
Tarzana, California, United States
Countries
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References
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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.
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.
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.
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.
Stein JH. Management of Lipid Levels and Cardiovascular Disease in HIV-Infected Individuals: Just Give Them a Statin? Top Antivir Med. 2016 Dec-2017 Jan;23(5):169-73.
Thompson-Paul AM, Lichtenstein KA, Armon C, Palella FJ Jr, Skarbinski J, Chmiel JS, Hart R, Wei SC, Loustalot F, Brooks JT, Buchacz K. Cardiovascular Disease Risk Prediction in the HIV Outpatient Study. Clin Infect Dis. 2016 Dec 1;63(11):1508-1516. doi: 10.1093/cid/ciw615. Epub 2016 Sep 9.
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.
Jin J, Sklar GE, Min Sen Oh V, Chuen Li S. Factors affecting therapeutic compliance: A review from the patient's perspective. Ther Clin Risk Manag. 2008 Feb;4(1):269-86. doi: 10.2147/tcrm.s1458.
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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.
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.
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.
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.
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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Other Identifiers
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