Health Care Systems Interactions
Many obstacles hamper the conduct of clinical research in healthcare delivery systems. Foremost among these are the need for health system leaders, clinicians, and patients to want to participate in research, to trust that their interests will be well served by participation, and for the research not to disrupt delivery of clinical care. This core will facilitate productive collaborations by:
engaging those involved in delivery systems to participate in research
facilitating the design and conduct of research protocols attractive to practitioners
lowering administrative barriers
communicating results to all parties
We will collaborate with NIH staff in these activities. We will create a repository of policies and procedures that enable investigators to collaborate with health systems and with one another across the full spectrum of clinical research, with a focus on pragmatic and cluster randomized trials. These policies will address both research for which the health systems stand to gain immediate benefit, and also research that contributes to the public good but is not in their immediate best interests. We describe a detailed set of tasks below. We will work with NIH staff and the demonstration projects to develop guidances for research conducted in partnership with diverse healthcare systems, engaging key leaders from delivery systems, investigators, as well as public and private research sponsors, payers, providers, patients, and the public to determine approaches that will best align these groups for common purpose. This will allow us to develop consensus-based model policies, procedures, and best practices that build both enthusiasm and trust. We will also conduct an environmental scan and inventory in Year 1 to procedures that focus on topics unique to health systems-based research while avoiding redundancy with broadly applicable tools (www.researchtoolkit.org). In addition, we will create model governance policies and recommended procedures that support multisite collaborations based in health systems, building on our experience with eMERGE, Mini-Sentinel, CTTI, and the DCRI. These will specifically address policy considerations regarding the use of delivery systems‟ electronic infrastructure (collaboration with EHR core). In addition to interacting with the other Cores and Working Groups to ensure that provider and health system issues are reflected in their guidelines and best practices, we have identified the following critical areas:
Engaging delivery system leaders, clinicians, and patients. We will develop and catalogue best practices and methods to engage persons both within and outside of the research community to promote support for bidirectional “learning” through research in topics that represent interests of both the research community and the public. We will include health system leadership, providers and staff, patients and family members, and investigators from a variety of disciplines and institutional homes. Articulating and incorporating best practices for research governance will address an array of topics including expectations among researchers and delivery systems regarding decision making, authorship, ownership of intellectual property and other products.
Facilitating design. This work includes articulating technical, policy, and workflow practices, especially as they relate to collaborations on PCTs in delivery systems. We will also coordinate with the EHR Core in gaining institutional support for sharing selected clinical and system information. We will also focus on explaining issues related to organizational ownership and regulatory matters, and work with evolving systems and committee members to describe best practices for improving ascertainment of clinically relevant data at the point of care.
Lowering administrative barriers. We will address policies that simplify execution of inter-institutional contracting and other agreements. We will 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. The goal of this work is a standardized and efficient regulatory process that addresses regulatory, privacy, compliance, and fiduciary concerns of delivery systems. This goal will be enhanced by a major CTTI project developing guidances and best practices for central ethics review and CTSA Working Groups evaluating central IRBs for academic health systems and the general process of "study start-up," including IRB review, contracting, and protocol training.
Communication. We will work with all stakeholders to develop best practice documents to facilitate communication to all stakeholders during the planning and implementation phases, as well as communication of study results, both broadly and, when appropriate, to individual participants.
We will specifically address the application of these topics to the life cycle of clinical trials:
Protocol development. We will identify current best practices for the interaction among researchers, providers, and administrators. An additional issue that must be addressed is optimizing interactions with FDA when experimental drugs or devices are used in a protocol. While CTTI provides an excellent forum for this effort, each study will require the type of expert knowledge of the DCRI regulatory group to assist those who have not dealt with the multiple FDA divisions.
Study start-up. We will address IRB decision-making, contracting, assembling study teams, and orienting trialists and clinicians. We will develop a source of shared knowledge about the system by which these processes are interrelated and optimized. While general IRB and contracting issues are germane to all types of clinical research, the Collaboratory will foster the learning health system culture so that research protocols are widely shared and vetted carefully.
Study conduct. The Collaboratory can develop more effective approaches in several key areas. Enrollment of research participants will involve locating appropriate patients, reaching agreement with providers that the patient should be offered the opportunity to join a study, obtaining consent, scheduling and conducting study procedures, ensuring that appropriate data are recorded, and sending notification to investigators, study team members and research participants as the study evolves. Integration of research into the delivery system should keep patients and providers more engaged and better able to meet the needs of the trial in conjunction with other aspects of care in addition to better tested protocols for acceptability prior to study initiation. The collection of follow-up data can be enhanced at a markedly reduced cost compared with traditional trials. We will articulate policy options and coordinate this work with that of the EHR Core, which will address specific implementation options. Our work product will be aligned with the OCRe, so that investigators, providers, and administrators can readily find pertinent material.
Study closeout. Economies can be developed to optimize distribution and collection of study materials. More importantly, the combination of EHRs, PROs, and integrated systems will enable involvement of research participants in study closeout, and in the interpretation and dissemination of study results when the trials are completed. This approach will involve providers, administrators, and patients in a continuous learning system together with the research experts performing the conceptual study design and analysis.