Whether study teams choose to use a formal framework to characterize or report on adaptations to their study interventions, tracking such modifications will be key to ensuring that you understand the internal validity of the study. One prominent framework is FRAME.

FRAME

The Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) is an approach developed, and recently expanded, by Wiltsey Stirman and colleagues to help study teams identify and report modifications to interventions or implementation strategies—planned and unplanned (Stirman 2013; Wiltsey Stirman 2019). FRAME, an update and synthesis of earlier adaptation research and models (Glasgow et al. 1999), helps researchers compare the impact of a modification with the impact on fidelity to the intervention. The FRAME approach can be used to track and document aspects of the intervention’s implementation such as why, when, and where the change occurred; the nature of the change; the target of the change; and, importantly, the goal of the change—for example, to improve effectiveness, increase reach or engagement, or reduce cost.

As an example,  a recent study documented the process and outcomes of adapting the Savvy Caregiver Program (SCP) for Korean American dementia caregivers according to the 8 domains in FRME:

1. What was modified,
2. Who participated in recommending and deciding the modification to be made,
3. When the modification occurred
4. Whether the modification was planned
5. Whether the modification was fidelity-consistent
6. Whether the modification was temporary
7. At what level of delivery, the modification was made, and
8. Why the modification was made.(Jang et al. 2024)

The study team found that the primary reasons for adaptations were to improve he primary for engagement (62.5%) and fit with recipients (43.8%)(Jang et al. 2024).

The authors state: “The FRAME categorization provided a detailed understanding of the process and nature of adapting the SCP [Savvy Caregiver Program] and served as a foundation for further implementation and scale-up. FRAME not only serves as a guide for adapting evidence-based interventions but also promotes their replicability and scalability (Jang et al. 2024).

Other Frameworks

RE-AIM

The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework was designed to help study teams evaluate “essential program elements including external validity that can improve the sustainable adoption and implementation of effective, generalizable, evidence-based interventions” (Glasgow et al. 1999; www.re-aim.org). Read more about RE-AIM in the Dissemination and Implementation Chapter.

RAPICE

The approach called Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) uses ethnographic methods to collect and analyze qualitative data about a clinical intervention in a relatively short period (Palinkas and Zatzick 2019).

Additional Considerations

The Living Textbook identifies other considerations related to potential changes to the intervention:

• The section on designing the analysis plan discusses unanticipated changes, such as changes to the study population, organizational structure, or clinical practice and standards that may have an impact on the analysis of your study.
• The section on using electronic health record (EHR) data in clinical research discusses how EHR data can support the process of monitoring the fidelity of the intervention.
• If the ePCT intervention proves effective, the section on dissemination provides information on frameworks for dissemination and implementation.