MEDication Focused Outpatient Care for Underutilization of Secondary Prevention (MEDFOCUS)
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January 2015 – September 2018
Dataset(s) Last Updated
September 9, 2021
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
The MEDFOCUS study aimed to evaluate whether a centralized, web-based cardiovascular risk service managed by clinical pharmacists would improve guideline adherence in multiple primary care medical offices with diverse geographic and patient characteristics.
Adherence to guidelines for cardiovascular disease (CVD) treatment and prevention is low with regional and age variations. The primary barrier is suboptimal medication use leading to poor disease control, often because busy providers must address acute non-CVD complaints. Numerous studies have demonstrated the value of including pharmacists in team-based care to improve adherence to cardiovascular guidelines, medication adherence and risk factor control. However, onsite clinical pharmacists are often too busy to provide the frequent contact needed for adherence and medication management. Additionally, there is limited information on whether team-based care models can be successfully implemented more widely in diverse settings and populations. Therefore, the MEDFOCUS study was initiated to determine whether a centralized cardiovascular risk service (CVRS) managed by clinical pharmacists could be implemented in large numbers of medical offices and if it would be effective in diverse populations.
Eligible participants were English speaking males or females greater than 55 years of age with a history of at least one of the following: coronary artery disease, myocardial infarction (MI), stroke, transient ischemic attack (TIA), atrial fibrillation, systolic heart failure or the following coronary artery disease (CAD) risk equivalents - peripheral vascular disease/claudication, carotid artery disease or diabetes mellitus with co-existing uncontrolled hypertension and/or hyperlipidemia.
A total of 402 subjects were enrolled.
MEDFOCUS was a 5-year, prospective, cluster-randomized multi-center clinical trial in 20 medical offices from 11 states in the US. Clinics were stratified on the percentage of racial minorities (high >40%, low <40%) and then randomized to the CVRS intervention or control group. A study coordinator (SC) in each office enrolled approximately 20 subjects who met inclusion criteria. Subjects were followed prospectively for 12 months. In addition, chart-audited data was collected on all subjects at 24 months to determine the effect of the intervention once it was discontinued.
The SC administered questionnaires on barriers to medication adherence at baseline. The SC also administered readiness to change health behaviors surveys at baseline and 12 months in both control and intervention subjects. The results of this survey for the intervention group subjects were made available to the CVRS pharmacist at baseline to allow for tailoring their interactions to best motivate patient behavior change. The CVRS pharmacists provided frequent education, alerts, and reminders to the patients in the intervention group. The CVRS pharmacists did not make independent care decisions but made recommendations for implementation to the onsite clinical pharmacists. Subjects in the control group received usual care. Guidelines were adapted from the Guideline Advantage criteria and adherence was measured as a percentage of applicable criteria met for each subject.
The primary outcome was the difference in guideline adherence between the control and intervention groups.
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 1.3 MB)
- MEDFOCUS Case Report Forms (PDF - 2.3 MB)
- MEDFOCUS Manual of Operations (PDF - 2.3 MB)
- MEDFOCUS Protocol (PDF - 1.4 MB)
- MEDFOCUS Statistical Plan (PDF - 1.5 MB)
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