Dataset Information

Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention.

ABSTRACT:

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/.

SUBMITTER: Ridgeway JL

PROVIDER: S-EPMC10876585 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention.

Ridgeway Jennifer L JL Cheville Andrea L AL Fischer Kristin J KJ Tesch Nathan K NK Austin Jessica D JD Minteer Sarah A SA Pachman Deirdre R DR Chlan Linda L LL Ruddy Kathryn J KJ Griffin Joan M JM

Contemporary clinical trials communications 20240209

<h4>Background</h4>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.<h4>Methods</h4>Study activities were documented in a spreadsheet by date and category. Intervention adaptations were tracked across multiple workgroups in a database structured ...[more]

PMID: 38380342

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Dataset Information

Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention.

Background

Methods

Results

Conclusions

Trial

Publications

Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention.

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