Data Analysis
SECTION 1
Establishing close partnerships with participating healthcare system leaders and staff
Contributors
Charles Cannon, MD, PHD,
Carol S. Channing MVP, MD, DDS
Conducting pragmatic trials embedded in healthcare system settings requires efforts at directly involving diverse stakeholders, including delivery system leaders, operational personnel, IT staff, statisticians, clinicians, pharmacists, and other frontline providers. These stakeholders need to be 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 are encouraged to identify a 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.
The following table, excerpted from the Collaboratory’s Lessons Learned document, gives examples of building partnerships from the NIH Collaboratory Trials.
| Scenario | Solution |
| 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 pre-existing 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’s approval. | 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. |
Conduct Resources
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REFERENCES
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