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

dc.contributor.author Heisler, Michele
dc.contributor.author Hofer, Timothy P
dc.contributor.author Klamerus, Mandi L
dc.contributor.author Schmittdiel, Julie
dc.contributor.author Selby, Joe
dc.contributor.author Hogan, Mary M
dc.contributor.author Bosworth, Hayden B
dc.contributor.author Tremblay, Adam
dc.contributor.author Kerr, Eve A
dc.coverage.spatial England
dc.date.accessioned 2011-06-21T17:30:25Z
dc.date.issued 2010-10-12
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/20939913
dc.identifier 1745-6215-11-95
dc.identifier.uri https://hdl.handle.net/10161/4380
dc.description.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.
dc.language eng
dc.language.iso en_US
dc.publisher Springer Science and Business Media LLC
dc.relation.ispartof Trials
dc.relation.isversionof 10.1186/1745-6215-11-95
dc.subject Antihypertensive Agents
dc.subject Biomarkers
dc.subject Blood Pressure
dc.subject California
dc.subject Cholesterol, LDL
dc.subject Clinical Protocols
dc.subject Cluster Analysis
dc.subject Diabetes Mellitus
dc.subject Drug Prescriptions
dc.subject Health Maintenance Organizations
dc.subject Hemoglobin A, Glycosylated
dc.subject Humans
dc.subject Hypertension
dc.subject Insurance, Pharmaceutical Services
dc.subject Medication Adherence
dc.subject Pharmacists
dc.subject Practice Patterns, Physicians'
dc.subject Primary Health Care
dc.subject Research Design
dc.subject Time Factors
dc.subject Treatment Outcome
dc.subject United States
dc.subject United States Department of Veterans Affairs
dc.title Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.
dc.title.alternative
dc.type Journal article
duke.contributor.id Bosworth, Hayden B|0212403
dc.description.version Version of Record
duke.date.pubdate 2010-10-12
duke.description.issue
duke.description.volume 11
dc.relation.journal Trials
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/20939913
pubs.begin-page 95
pubs.organisational-group Center for the Study of Aging and Human Development
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Duke Cancer Institute
pubs.organisational-group Institutes and Centers
pubs.organisational-group Medicine
pubs.organisational-group Medicine, General Internal Medicine
pubs.organisational-group Psychiatry & Behavioral Sciences
pubs.organisational-group School of Medicine
pubs.publication-status Published online
pubs.volume 11
dc.identifier.eissn 1745-6215


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