​Health Care Systems Interactions

​Health Care Systems Interactions

Chair: Eric B. Larson

NIH Representatives: David Chambers, Jerry Suls

Members: Alison Bonifay, Gloria Coronado, Lynn DeBar, Laura Dember, Jana Friendly, Laura Heim, Susan Huang, Leah Ingraham, Adeola Jaiyeola, Katie James, Jeffrey Jarvik, Sherry Johnson, Vincent Mor, Greg Simon, Miguel Vazquez, Angelo Volandes, Barbara Yody, Doug Zatzick

Research Associate: Leah Tuzzio

Project Manager: James Fraser

 

Products and Publications | Presentations

To foster the culture of a learning healthcare system and conduct pragmatic clinical research within healthcare delivery systems, a paradigm shift is needed among health system leaders, clinicians, and researchers. The Health Care Systems Interactions Core aims to support and facilitate productive collaboration between researchers, clinicians, and health system leaders. Its goals are to engender partnerships so these stakeholders are eager to participate in research and trust that their interests, including providing excellent care to their patients, will be well served by participation, and to share knowledge on conducting research in a way that does not disrupt the delivery of clinical care or health systems’ operations.

To accomplish these goals, the Core is working with the NIH, other Collaboratory Cores, and Demonstration Projects to identify challenges with pragmatic clinical trials and cluster randomized trials, consult about these issues, provide an open forum for discussion, and develop tools and best practices for research conducted in partnership with diverse healthcare systems. The Core engages leaders from healthcare delivery systems, investigators, public and private research sponsors, payers, providers, and the public, to develop consensus-based model policies, procedures, and best practices that build enthusiasm and trust.

Area of Focus

The Core’s efforts are focused in four key areas:

Engage health system leaders and clinicians

  • Determine approaches that will best align these groups and researchers for common purpose

  • Develop and catalog consensus-based best practices

  • Promote bidirectional learning on topics of interest

  • Incorporate best practices for research governance on matters including decision making, authorship, and ownership of intellectual property and other products

Facilitate study design

  • Articulate technical, policy, and workflow practices, especially as they relate to collaborations on pragmatic clinical trials

  • Coordinate with the Electronic Health Records Core in gaining institutional support for sharing selected clinical and system information

  • Explain issues related to organizational ownership and regulatory matters

  • Describe best practices for improving collection of clinically relevant data at the point of care

Lower administrative barriers

  • Address policies that simplify execution of inter-institutional contracts and other agreements

  • Collaborate with the Regulatory/Ethics Core to develop clear guidances and model agreements for addressing regulatory requirements for various types of studies in a uniform manner

  • Standardize efficient processes that address regulatory, privacy, compliance, and fiduciary concerns of health systems

  • Complement and build on work by the Clinical Trials Transformation Initiative and Clinical and Translational Science Award Working Groups on centralized IRB review and study start-up

  • Optimize interactions with regulators

Promote communication

  • Develop best practices for facilitating communication with all stakeholders during trial planning and implementation phases

  • Support enrollment and ensure appropriate data collection through communication with providers and healthcare systems

  • Encourage communication of study results, both broadly and, when appropriate, to individual participants

  • Involve research participants in the interpretation and dissemination of results

These activities are applicable throughout the life cycle of clinical trials:


Presentations

5/9/2016: Health Care Systems Interactions Core Presentation at Steering Committee Meeting

2/27/2015: Grand Rounds Presentation: Integrating Research Into Health Care Systems: Executives' Views (Video; Slides)

8/19/2014: Health Care Systems Interactions Core Presentation at Steering Committee Meeting

7/25/2014: Grand Rounds Presentation: Health System Leaders Working Toward High-Value Care Through Integration of Care and Research (Video; Slides)

2/25/2014: Health Care Systems Interactions Core Presentation at Steering Committee Meeting

2/14/2014: Grand Rounds Presentation: Engaging Health Systems in Research Partnerships: Insights from the NIH Collaboratory's PCTs (Video; Slides)

1/10/2014: Grand Rounds Presentation: Incorporating Research Driven Changes into Health Care Systems' IT Operati​ons: A Multi Perspective Panel Discussion (Video; Slides)

6/7/2013: Grand Rounds Presentation: Minimizing the Burden of Research on Healthcare Systems (Video; Slides)

1/11/2013: Grand Rounds Presentation: Health Care Systems Interactions Core (Video; Slides)

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Citation:

​Health Care Systems Interactions: ​Health Care Systems Interactions. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://www.rethinkingclinicaltrials.org/%e2%80%8bhealth-care-systems-interactions/. Updated November 22, 2017.