Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.
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 articleSubject
Antihypertensive AgentsBiomarkers
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
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https://hdl.handle.net/10161/4380Published Version (Please cite this version)
10.1186/1745-6215-11-95Publication 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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Show full item recordScholars@Duke
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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