Embedded Pragmatic Clinical Trial Team Composition
Potential Roles and Expertise
Karen Staman, MS
Liz Wing, MA
The expertise necessary for a trial will depend on the specific study aims and how the intervention will be embedded in the healthcare system workflow. A simplified example of the roles the team members could fulfill is shown in the table.
|Role||Priority||Study question refinement||Protocol development||Conduct|
|Researcher||Improve public heath by answering research questions||Develops and procures funding for research question||Drafts protocol||Ensures sustainability. Communicates with team. Helps to solve issues as they arise|
|Patient||Improve individual health or the health of others with a similar condition||Provides feedback||Provides feedback||May participate in study|
|HCS leader||Improve patient outcomes, reduce costs, and increase efficiency||Ensures question aligns with priorities and mission||Provides feedback, promotes and supports study||Promotes and supports study|
|IT Staff||EHR features that support patient care and billing||May need to adapt EHR for data collection. Can advise on feasibility||Responsible for data collection and/or data pulls. Will help mitigate problems with data quality (consistency, anomalies, errors, etc)|
|Frontline and Operational Staff||Patient care||Consult on protocol so it fits into workflow with a little burden as possible. Advise on feasibility||Responsible for data collection and/or implementing interventions|
|Clinic Champion||Improving patient outcomes||Refines question with researchers and HCS leaders||Serves a liaison and helps integrate protocol into workflow||Ensures sustainability. Helps to solve issues as they arise.|
Clinical and heath care system staff and team members tend to have high turnover rates, which creates challenges for ePCTs . Developing good documentation and training practices for new team members helps ensure sustainability in case of turnover. Perhaps more importantly, NIH Collaboratory PIs have found that engaging staff throughout the trial and developing clear methods for multidirectional communication can help identify and mitigate potential issues before they become acute. For example, the STOP CRC trial implemented a well-validated quality improvement approach called Plan-Do-Study-Act, or PDSA. The use of PDSA helped to identify implementation issues and unintended consequences and empowered clinics to actively address local conditions.
A directory of team members is advisable, for example, the Health Care Services Research Network (a network of healthcare systems that participate in research) provides a directory on their website with key administrative contacts by site.
At the end of the trail, team members, including participating sites, physicians, and/or clinics, should have the opportunity to receive, interpret, and implement findings from the trial. Likewise, where applicable, findings should also be communicated to patients or patient advocacy groups.
To determine what skills are needed, consider the following key questions in the planning phase:
- What clinical specialties will be needed to carry out the intervention?
- What roles will support clinic operations?
- Who will be the liaison between healthcare system departments for interventions that are multidisciplinary?
- What aspects of the trial will require IT staff expertise?
- Will the trial need training videos, online materials or toolkits?
This working document helps ePCT teams plan training for study procedures that involve front-line clinicians and staff.