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. Patients with CVD have high levels of complexity and tend to have numerous chronic conditions. The Patient-Centered Medical Home including self- management, personalized health records and team-based care is a strategy to improve care for patients with multiple chronic conditions. Managed care organizations have found that a centralized cardiovascular risk service managed can reduce mortality. It is not known if a Prevention Health &Cardiovascular Risk Service (PHCVRS) including cancer screening would be implemented in private office practices that lack clinical pharmacists or specialized nurses. Our long-range goal is to improve the management of patients with complex medical histories with team-based care. We have pioneered strategies to evaluate team care implementation and guideline adherence using cluster-randomized trials. The objective of this application is to conduct a multi-center, cluster-randomized study utilizing a centralized PHCVRS to support private medical offices in more rural areas that lack large integrated health plans. This study is titled """"""""Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care: ICARE."""""""" We will stratify and randomize 12 primary care offices in the Iowa Research Network (IRENE) to PHCVRS or usual care and enroll 300 subjects. We will also randomly select 25 patients per office (n=300, total n=600) into a passive observation group that will allow us to determine the extent to which the intervention diffuses more broadly for unexposed patients. Our central hypothesis is that the PHCVRS will significantly improve adherence to The Guideline Advantage metrics that are supported by five national organizations. The rationale for this proposed study is that implementation of a novel approach to improve management of CVD and cancer screening will lead to innovative strategies for broader adoption by health systems throughout the U.S. We will accomplish our objectives and test our central hypothesis with the following specific aims:
Aim 1 : To determine if a web-based PHCVRS will be implemented within private primary care offices.
Aim 2 : To determine if the PHCVRS intervention diffuses throughout the intervention offices. Our approach is innovative because it will ask the questions: """"""""Will the PHCVRS model be successfully implemented?"""""""" as well as """"""""Is care management effective?"""""""" These questions have not been addressed for patients with multiple chronic conditions in private practice. This study design is novel because it will: 1) be the most robust study to test this model using a cluster randomized design in small private practice clinics, 2) evaluate whether the effect can be sustained long-term, and 3) evaluate a """"""""passive observation group"""""""" to determine if the intervention diffuses throughout the practice.

Public Health Relevance

The proposed study is relevant to public health because the implementation of strategies to efficiently provide care for patients with multiple chronic conditions will lead to improved and more comprehensive primary care. The proposed research is relevant to NHLBI strategic plan that deals with implementation of effective strategies to improve guideline adherence for cardiovascular disease. The results of this study will help to achieve important milestones for the Million Hearts Campaign and the goals of the American Cancer Society (ACS), American Diabetes Association (ADA) and the American Heart Association (AHA) for their Guideline Advantage program.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project (R01)
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Clinical Trials Review Committee (CLTR)
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Stoney, Catherine
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University of Iowa
Schools of Pharmacy
Iowa City
United States
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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; Levy, Barcey T; Gryzlak, Brian et al. (2015) A centralized cardiovascular risk service to improve guideline adherence in private primary care offices. Contemp Clin Trials 43:25-32
Carter, Barry L (2015) Will Team-Based Care Really be Implemented? J Clin Hypertens (Greenwich) 17:692-3