Conducting PCTs embedded in healthcare system settings requires efforts at directly involving diverse stakeholders, including delivery system leaders, operational personnel, IT staff, statisticians, and frontline care providers. Input from these stakeholders is an important part of the trial’s design and planning. Establishing and maintaining good relationships and communication are essential for the long-term success of the trial.
Study teams should identify at least one co-investigator at each study site who will serve as an integral project member and a site champion over the course of the project. Having such a research partner is important in understanding who is affected by the embedded elements of your intervention. Champions not only can identify inefficiencies or constraints not evident at higher levels of the organization, but also have experience in fixing problems internally. Choosing the right partner is critical. They need to have enough experience to know how to effectively troubleshoot within their system and have the respect of system leaders and influence within their organization to implement solutions. Both the study team and the healthcare system may need to make adjustments or accommodations for competing priorities throughout the trial planning and execution phases.
The following table gives example scenarios of building partnerships from the Demonstration Projects.
Establishing Partnerships Examples
|EHR programming staff at the site prioritized clinical needs over research needs, which led to delays in data pulls for the trial.||Engaged with site programmers early in the project to help them develop and maintain an investment in the trial’s purpose and research methods. A helpful approach is to have the study team regularly informed of the programmers’ priorities. Clinical-based programmers generally have different priorities than research-based programmers.|
|Intervention is in the primary care setting where schedules are busy and space is tight.||Teamed with clinicians to understand workflow and schedule study-related patient visits during slower clinic periods and held patient visits in less conventional ways (after hours, groups met in lobby spaces).|
|High amounts of leadership turnover at medical director and provider levels due to preexisting pressures and challenges inherent in community clinics.||Met regularly with leadership teams and established an advisory board and other infrastructure to help engage leaders and gatekeepers.|
|Leadership approval of the study was delayed because different departments within a single healthcare system were unable to initiate approval without the other departments going first. For example, Stakeholder A could not approve the study before Stakeholder B approved.||Facilitated in-depth discussions of the project with all the relevant stakeholders on the phone or web at the same time, when face-to-face meetings were not possible. A prior history of collaboration among investigators and support from senior officers in the healthcare systems was instrumental in obtaining approval.|
- Developing the Trial Documentation
- Establishing Close Partnerships With Participating Healthcare System Leaders and Staff
- Delineating the Roles of All Stakeholders to Determine Training Needs
- Pilot Testing
- Feasibility Assessment Scenarios From the Collaboratory’s Demonstration Projects
- Spotlight on Four Demonstration Projects
- Additional Resources
Learn more in the chapter Engaging Stakeholders and Building Partnerships to Ensure a Successful Trial
These articles by members of the NIH Collaboratory’s Health Care Systems Interactions Core contain tips and guidance for pragmatic trial study teams:
- A guide to research partnerships for pragmatic clinical trials (Johnson KE, et al. BMJ 2014).
- Trials without tribulations: minimizing the burden of pragmatic research on healthcare systems (Larson EB, et al. Healthcare 2015).