Current Research Abstracts

9/1/04-7/29/07 - $353,822

Michigan Clinical Research Collaboratory (MCRC) Project

Abstract

This proposal describes steps that will integrate clinical research centers of excellence with established community primary care networks. Only then, will the effectiveness of research advances be tested in real-life settings; only then will community physicians develop a sense of “ownership” of results and more rapidly translate research advances into their practices, and only then will the findings of primary care clinicians and research networks be iteratively re-translated bidirectionally back into traditional academic research networks.

Specifically, this project will demonstrate the feasibility of providing a common infrastructure to three existing practice-based networks affiliated with the university of Michigan: 1) a statewide network of community private practice Family Practice physicians (GRIN); 2) a University of Michigan-based Primary care Depression Network affiliated with the Depression Center; and 3) a community hospital-based cardiovascular network. These networks currently use dramatically different human and IT systems to perform research. The infrastructure that each utilizes will be re-engineered and integrated in terms of the “human” procedures (common languages and data-collection procedures) that are necessary to perform high-quality and compliant clinical research in multiple community-based practices, and in information technology (IT) systems that can facilitate this new method of performing research. The result will be a new integrated entity—the Michigan Clinical Research Collaboratory (MCRC). A feasibility project will assess differences in treatment responses, recurrences, rehospitalizations, mortality and costs for those with co-occurring cardiovascular and depressive disorders and those with only cardiovascular problems. To test the goals of this BAA, this project will be rolled out in staged fashion and then conducted concomitantly in Michigan’s Cardiovascular Center, Depression Center, and the three affiliated primary care networks. New research centers and primary care networks will be progressively added to the MCRC in future years.

The central “hub” of this entity will be the University of Michigan Center for Advancement of Clinical Research (CACR). CACR is a unique unit that provides infrastructure and support for clinical research at the UofM, and has extensive experience in al facets of clinical research necessary for such re-engineering. Its assets include: 1) a Clinical Research Informatics Core that has developed an in-house software program that successfully runs several hundred clinical research protocols, a program that will be re-engineered for increased use of operation and security and will serve as the launching point for this BAA; 2) a Project Management and Monitoring Core that serves as the Data Coordinating Center for several NIH multicenter trials; 3) an Education Core that focuses on educating both physicians and other study personnel in clinical research practices; 4) a Research Development Core that helps investigators with study ideas convert these ideas into high quality protocols; and 5) a Biometrics and Outcomes Resources Core that provides biostatistical support for clinical research.

The re-engineering of the “human” processes will involve meeting with stakeholders from each of the three networks to: 1) identify and/or develop common processes and languages that all three groups find acceptable, do not impede practice workflow and encourage active participation of their network physicians; 2) ensuring that re-engineered processes meet regulatory and compliance standards and are inherently efficient; 3) developing QI-based rollout and improvement programs for rapid integration of networks; 4) developing a work plan to implement the feasibility project in all three networks, demonstrate the value of participation, and disseminate findings. Inderdisciplinary team leaders have already begun the processes, milestones have been established, and endorsement of all key leaders had been obtained.

The MCRC is designed to achieve the goals set forth in the BAA. The net result will be an open-source, inter-operative system that produces effective interfaces among traditional research silos, catalyzes interdisciplinary research, fosters prompt bi-directional translation, educates a new generation of interdisciplinary investigators, and develops and disseminates standards believed to be compatible with ongoing national efforts such as NECTAR.

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