Abstract
BackgroundMany 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.MethodsIn 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.DiscussionIntegration 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 RegistrationThe ClinicalTrials.gov registration number is NCT00495794.
Highlights
Many patients with diabetes have poor blood pressure (BP) control
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
Outcome Measures Primary Outcome The primary outcome is the relative change in systolic blood pressure measurements over time as recorded at the point of care in Veterans Affairs (VA) and Kaiser Permanente (KP) electronic databases
Summary
Experimental Design Overview and Aims This study was conducted as a cluster-randomized effectiveness study in which primary care teams, within sites, were randomized to one of two conditions: proactive case identification followed by adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing) or usual care. At VA sites, providers on usual care teams received reports on each of their diabetic patients who had poor blood pressure control and adherence or intensification issues. Outcome Measures Primary Outcome The primary outcome is the relative change in systolic blood pressure measurements over time as recorded at the point of care in VA and KP electronic databases (excluding blood pressures measured by the AIM pharmacists) As this is an effectiveness study, change in each group will be assessed by the comparison of a precision weighted average of the values obtained during routine outpatient clinical practice in 6 month windows preceding and following the intervention period. Our sample size calculations demonstrated that with an average of 275 participants contacted (or attempted to be contacted) per team, we could detect a 4.4 mmHg difference with a power 0.8 with only 2 observed blood pressures per person in each of pre and post intervention measurement windows, under the most pessimistic assumptions of an ICC of 0.02
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