Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. There is evidence that these deaths can be prevented with better risk factor management, however, many risk factors remain uncontrolled. The Patient-Centered Medical Home (Medical Home) which includes self-management, personalized health records and team-based care, has been proposed as a strategy to reduce these gaps in care delivery. Several Cochrane reviews and meta-analyses have found evidence that adding pharmacists to the primary care team improves risk factor control and physician adherence to guidelines. Managed care organizations have found that a centralized cardiovascular risk service (CVRS) managed by pharmacists can reduce mortality. It is not known if a comprehensive CVRS model would be implemented in typical office practices and this lack of evidence is a major gap in the literature. The objective of this application is t conduct a multi-center, cluster-randomized study utilizing a centralized CVRS in medical offices with large geographic, racial and ethnic diversity to determine the extent to which the CVRS model will be implemented. We will randomize 16 primary care offices to the CVRS or usual care and enroll 400 subjects of which 220 subjects will be from racial minorities. We will also select 25 patients per office (n=400, total n=800) into a passive observation group which will allow us to determine the extent to which the intervention diffuses more broadly for unexposed patients. Our central hypothesis is that a centralized CVRS managed by clinical pharmacists will be implemented and significantly improve CVD guideline adherence using the Guideline Advantage metrics. The rationale for this proposed study is that implementation of a novel strategy to improve secondary prevention of CVD will lead to innovative strategies for broader adoption by health systems throughout the US. We will accomplish our objectives and test our central hypothesis with the following specific aims: Our primary Aim is: To determine if a web-based CVRS managed by clinical pharmacists will be implemented within diverse primary care offices. We postulate that adherence to guidelines for secondary prevention of CVD will be significantly greater in patients from clinics randomized to the centralized CVRS group compared to the control group. This study is expected to produce the following outcomes: guideline adherence will be 40% at baseline and increase to at least 60% in the intervention group at 12 months. We expect guideline adherence will deteriorate after the intervention is discontinued but will remain significantly higher than the control group.

Public Health Relevance

Risk factors for cardiovascular disease are poorly controlled even for subjects who frequently visit their physician. This problem leads to large numbers of preventable cardiovascular events such as heart attacks and strokes. Research suggests that risk factors can be controlled better and treatment strategies for cardiovascular disease can be markedly improved by using a centralized cardiovascular risk service managed by pharmacists. We are confident that this intervention model can become one strategy to markedly reduce cardiovascular events in the United States.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Demonstration and Dissemination Projects (R18)
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Study Section
Special Emphasis Panel (ZHL1)
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Einhorn, Paula T
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University of Iowa
Schools of Pharmacy
Iowa City
United States
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Kennelty, Korey A; Polgreen, Linnea A; Carter, Barry L (2018) Team-Based Care with Pharmacists to Improve Blood Pressure: a Review of Recent Literature. Curr Hypertens Rep 20:1
Carter, Barry L; Ardery, Gail (2016) Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones. J Am Heart Assoc 5:
Carter, Barry L; Coffey, Christopher S; Chrischilles, Elizabeth A et al. (2015) A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence. Pharmacotherapy 35:653-62
Carter, Barry L (2015) Will Team-Based Care Really be Implemented? J Clin Hypertens (Greenwich) 17:692-3
Carter, Barry L; Coffey, Christopher S; Ardery, Gail et al. (2015) Cluster-randomized trial of a physician/pharmacist collaborative model to improve blood pressure control. Circ Cardiovasc Qual Outcomes 8:235-43