Delineating the Roles of All Stakeholders to Determine Training Needs

Assessing Feasibility

Section 4

Delineating the Roles of All Stakeholders to Determine Training Needs


Lynn L. DeBar, PhD, MPH

Jeffrey G. Jarvik, MD, MPH

Leah Tuzzio, MPH

Miguel A. Vazquez, MD


Contributing Editors

Liz Wing, MA

Karen Staman, MS

Consider the roles of different stakeholders at each trial site and the training needed for frontline staff and operational personnel. Embedded PCT (ePCT) interventions have varying levels of complexity, and accordingly may involve clinicians (physicians, specialists, nurses), senior management, business operations personnel, IT staff, researchers, clinic champions, and practice facilitators. The intervention may fall anywhere along a spectrum from relatively “passive,” requiring initial planning with the staff implementing the intervention and then limited ongoing training, to relatively “active” and involve system-wide changes that would need reinforcement over time.

Consider how existing procedures in each setting will need to be adapted and whether the intervention will generate new care delivery processes and workflows. Training for embedded PCTs is optimally conducted within routine care and operations using the healthcare system’s existing training structure. Also, system change over time may need to be accommodated, for example, to orient new leaders and staff joining the system or to account for changes in electronic tools for clinical decision support.

The following checklist presents considerations for designing stakeholder training. For more guidance and examples, read Training Front-line Staff and Clinicians.

Checklist for PCT Training Design

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Item Considered/Completed
Determine implementation complexity
Determine the degree of involvement from stakeholders, the number of stakeholders, and the amount of ongoing training needed for the intervention
Coordinate with the study sites or care delivery organizations
Identify local contact/champion
Determine who needs to be trained
Check if standard training structures and materials are available
Determine if staff or clinicians in the organization are able to conduct study training
Review parallel training efforts or programs planned by the care organization that may overlap with study training plans
Human resources
Review existing staff roles with supervisor/manager and discuss study-specific responsibilities or tasks
Create scope of work for staff performing study tasks
Discuss potential contracting or hiring requirements with care delivery organizations’ Human Resources departments*
Training topics
Define new procedures and changes to existing clinic workflow
Review communications to be given to patients and suggestions for staff if patients have questions about the trial communications or procedures
Determine if staff roles require training on human subjects protection
Control and intervention arms
Develop specific training procedures for different study arms as relevant
Track training activities (study analyses may need this)
Training structure
Consider how standard training structures might correspond/not correspond with study training
Will a train-the-trainer approach work?
Fidelity monitoring
Consider how tools needed to track study procedures might also be used to indicate need for retraining
Encourage input from staff about tools to make tracking easier for them and update over time

*With respect to hiring, consider providing funds through the study to pay the personnel who are directly responsible for study procedures, which both prioritizes the study procedures and gives more control to investigators. In instances in which additional work is anticipated because of the intervention, the healthcare system could use study funds to directly hire the personnel needed, or to cover the effort of existing personnel if involved in the study.



Version History

December 10, 2018: Made nonsubstantive edits to text as part of annual content update (changes made by L. Wing).

Published August 25, 2017


DeBar LL, Jarvik JG, Tuzzio L, Vazquez MA. Assessing Feasibility: Delineating the Roles of All Stakeholders to Determine Training Needs. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated December 10, 2018. DOI: 10.28929/056.