Assessing Feasibility
Section 4
Delineating the Roles of All Interest Holders to Determine Training Needs
Consider the roles of different interest holders 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 interest holder training. For more guidance and examples, read Training Front-line Staff and Clinicians.
Checklist for PCT Training Design
| Item | Considered/Completed |
|---|---|
| Determine implementation complexity | |
| Determine the degree of involvement from interest holders, the number of interest holders, 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 | |
| Consider alignment of staff identities and lived experience with the population served | |
| Consult with local community organizations and DEI offices to ensure equitable hiring and support processes | |
| 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 related to research, 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.
SECTIONS
sections
- Introduction
- Developing the Trial Documentation
- Establishing Close Partnerships With Participating Healthcare System Leaders and Staff
- Delineating the Roles of All Interest Holders to Determine Training Needs
- Pilot Testing
- Feasibility Assessment Scenarios From the NIH Collaboratory Trials
- Spotlight on NIH Collaboratory Trials
- Additional Resources
current section : Delineating the Roles of All Interest Holders to Determine Training Needs
- Introduction
- Developing the Trial Documentation
- Establishing Close Partnerships With Participating Healthcare System Leaders and Staff
- Delineating the Roles of All Interest Holders to Determine Training Needs
- Pilot Testing
- Feasibility Assessment Scenarios From the NIH Collaboratory Trials
- Spotlight on NIH Collaboratory Trials
- Additional Resources