Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention
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 manageme...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2024-04-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865424000164 |
| _version_ | 1827313645324861440 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jennifer L. Ridgeway |
| collection | DOAJ |
| description | 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/ |
| first_indexed | 2024-03-08T00:48:40Z |
| format | Article |
| id | doaj.art-11e31634022545e594addc37a272f564 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-24T22:19:50Z |
| publishDate | 2024-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-11e31634022545e594addc37a272f5642024-03-20T06:10:50ZengElsevierContemporary Clinical Trials Communications2451-86542024-04-0138101269Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management interventionJennifer L. Ridgeway0Andrea L. Cheville1Kristin J. Fischer2Nathan K. Tesch3Jessica D. Austin4Sarah A. Minteer5Deirdre R. Pachman6Linda L. Chlan7Kathryn J. Ruddy8Joan M. Griffin9Division of Health Care Delivery Research, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA; Corresponding author. Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Mayo Clinic 200 First Street, SW, Rochester, MN, 55905, USA.Division of Medical Rehabilitation, Physical Medicine and Rehabilitation, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USARobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USARobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USADivision of Epidemiology, Quantitative Health Sciences, Mayo Clinic, 13400 E. Shea Boulevard, Scottsdale, AZ, 85259, USARobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA; Physical Medicine and Rehabilitation Research, Physical Medicine and Rehabilitation, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USADivision of Community Internal Medicine, Geriatrics, and Palliative Care, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USADivision of Nursing Research, Department of Nursing, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USADivision of Medical Oncology, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USADivision of Health Care Delivery Research, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USABackground: 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/http://www.sciencedirect.com/science/article/pii/S2451865424000164Implementation scienceLogic modelIntervention adaptationEvidence-based practiceCollaborative care model |
| spellingShingle | 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 Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention Contemporary Clinical Trials Communications Implementation science Logic model Intervention adaptation Evidence-based practice Collaborative care model |
| title | Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention |
| title_full | Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention |
| title_fullStr | Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention |
| title_full_unstemmed | Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention |
| title_short | Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention |
| title_sort | tracking activities and adaptations in a multi site stepped wedge pragmatic trial of a cancer symptom management intervention |
| topic | Implementation science Logic model Intervention adaptation Evidence-based practice Collaborative care model |
| url | http://www.sciencedirect.com/science/article/pii/S2451865424000164 |
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