RESUMEN
Background: Pragmatic trials may need to adapt interventions to enhance local fit, and adaptation tracking is critical to evaluation. This study describes the tracking approach for a multisite, stepped-wedge hybrid pragmatic trial testing implementation and effectiveness of a cancer symptom management intervention. Methods: Study activities were documented in a spreadsheet by date and category. Intervention adaptations were tracked across multiple workgroups in a database structured around the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) domains, e.g., reasons for change. Implementation strategies were tracked longitudinally and by cluster in a database using the Longitudinal Implementation Strategy Tracking System (LISTS) method. A logic model was created at the end of the study to describe core intervention components and implementation strategies with dates of adaptations. Results: Between January 2019 and January 2023, 187 study activities were documented. Most intervention activities took place early, but there were important intervention refinements during the course of the trial, including the expansion of interventionist roles to add two new disciplines. Eleven intervention adaptations were documented. Most were unplanned and aimed at improving fit or increasing engagement. Thirty-three implementation strategies were documented, the largest number of which were related to educating stakeholders. Most (but not all) component and strategy additions were consistent with the mechanisms of change as hypothesized at trial launch. Conclusions: A multifaceted approach to adaptation tracking, combined with a logic model, supported identification of meaningful changes for use in evaluation, but further work is needed to minimize burden and ensure robust and practical systems that inform both evaluation and timely decision-making. Trial: Registration: ClinicalTrials.gov, NCT03892967. Registered on March 25, 2019. https://www.clinicaltrials.gov/.
RESUMEN
BACKGROUND: Systematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time. METHODS: The development and initial evaluation of the LISTS method was conducted within the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer MoonshotSM). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User's Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study. RESULTS: Initial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies. CONCLUSIONS: The LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types.
