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Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.

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Date
2010-10-12
Authors
Heisler, Michele
Hofer, Timothy P
Klamerus, Mandi L
Schmittdiel, Julie
Selby, Joe
Hogan, Mary M
Bosworth, Hayden B
Tremblay, Adam
Kerr, Eve A
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Abstract
BACKGROUND: Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen. METHODS: In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates. DISCUSSION: Integration of the three intervention elements--proactive identification, adherence counseling and medication intensification--is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care. TRIAL REGISTRATION: The ClinicalTrials.gov registration number is NCT00495794.
Type
Journal article
Subject
Antihypertensive Agents
Biomarkers
Blood Pressure
California
Cholesterol, LDL
Clinical Protocols
Cluster Analysis
Diabetes Mellitus
Drug Prescriptions
Health Maintenance Organizations
Hemoglobin A, Glycosylated
Humans
Hypertension
Insurance, Pharmaceutical Services
Medication Adherence
Pharmacists
Practice Patterns, Physicians'
Primary Health Care
Research Design
Time Factors
Treatment Outcome
United States
United States Department of Veterans Affairs
Permalink
https://hdl.handle.net/10161/4380
Published Version (Please cite this version)
10.1186/1745-6215-11-95
Publication Info
Heisler, Michele; Hofer, Timothy P; Klamerus, Mandi L; Schmittdiel, Julie; Selby, Joe; Hogan, Mary M; ... Kerr, Eve A (2010). Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study. Trials, 11. pp. 95. 10.1186/1745-6215-11-95. Retrieved from https://hdl.handle.net/10161/4380.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Bosworth

Hayden Barry Bosworth

Professor in Population Health Sciences
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)  at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Cha
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