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

Bibliographic Details
Title: Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention
Authors: Jennifer L. Ridgeway, Andrea L. Cheville, Kristin J. Fischer, Nathan K. Tesch, Jessica D. Austin, Sarah A. Minteer, Deirdre R. Pachman, Linda L. Chlan, Kathryn J. Ruddy, Joan M. Griffin
Source: Contemporary Clinical Trials Communications, Vol 38, Iss , Pp 101269- (2024)
Publisher Information: Elsevier, 2024.
Publication Year: 2024
Collection: LCC:Medicine (General)
Subject Terms: Implementation science, Logic model, Intervention adaptation, Evidence-based practice, Collaborative care model, Medicine (General), R5-920
More Details: 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/
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2451-8654
Relation: http://www.sciencedirect.com/science/article/pii/S2451865424000164; https://doaj.org/toc/2451-8654
DOI: 10.1016/j.conctc.2024.101269
Access URL: https://doaj.org/article/11e31634022545e594addc37a272f564
Accession Number: edsdoj.11e31634022545e594addc37a272f564
Database: Directory of Open Access Journals
More Details
ISSN:24518654
DOI:10.1016/j.conctc.2024.101269
Published in:Contemporary Clinical Trials Communications
Language:English