Module 3-2 – Delivering the Intervention (14-Minute Video)

• This module walks learners through the essentials of putting a pragmatic trial into action. It highlights three key steps: preparing and supporting staff with the right tools, monitoring delivery across sites to ensure consistency, and documenting adaptations so that local innovations are captured without losing sight of the trial’s core design.

** The video's content and narration were generated with the assistance of artificial intelligence, with human guidance and oversight throughout the process. **

FRAME Coding Sheet  (Source) 

The FRAME Coding Sheet is a checklist-style tool for documenting adaptations and modifications to interventions. It provides structured fields to record when a modification occurred, whether it was planned or reactive, who participated in the decision, what was modified (content, context, training, implementation activities), and the level of delivery affected. 

This coding sheet is designed to be used alongside the FRAME Codebook (below).

Attribution: Downloaded from Stanford Medicine F.A.S.T. Lab on August 30, 2025.

FRAME Codebook  (Source) 

The FRAME Coding Manual (December 3, 2023 Version) was designed to support the systematic documentation of adaptations and modifications to evidence-based interventions. It provides structured coding categories for when adaptations occurred, who made them, what was modified, the level of delivery, the nature of modifications, their relationship to fidelity, and the rationale behind changes. It also incorporates guidance on equity considerations and includes fillable coding sheets and checklists for consistent reporting.

Source: Wiltsey Stirman, S., Baumann, A.A., & Miller, C.J. (2019). The FRAME: An expanded framework for reporting adaptations and modifications to evidence-based interventions. Implementation Science, 14(1), 5. https://doi.org/10.1186/s13012-018-0815-y

Attribution: Downloaded from Stanford Medicine F.A.S.T. Lab on August 30, 2025.

FRAME Excel Tracking Spreadsheet  (Source) 

This spreadsheet supports a centralized FRAME coding process for a project team. It lists each FRAME code, with drop-down menus and space to enter additional details when needed.

The spreadsheet was developed by Alex Dopp at RAND for the CLARO project. Note that the team included a new code to capture which Collaborative Care intervention components were involved in each adaptation; this could be replaced with a similar code for a different intervention, or removed entirely.

Attribution: Downloaded from Stanford Medicine F.A.S.T. Lab on August 30, 2025.

The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions (Source)

The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare (Source) 

A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems (Source)

 Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry (Source) 

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1): a pragmatic stepped-wedge, cluster randomized controlled registry trial (Source)