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 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/.

The Longitudinal Implementation Strategy Tracking System (LISTS): feasibility, usability, and pilot testing of a novel method.

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.

Implementing cancer symptom management interventions utilizing patient-reported outcomes: a pre-implementation evaluation of barriers and facilitators.

PURPOSE: Symptoms can negatively impact quality of life for patients with a history of cancer. Digital, electronic health record (EHR)-integrated approaches to routine symptom monitoring accompanied by evidence-based interventions for symptom management have been explored as a scalable way to improve symptom management, particularly between clinic visits. However, little research has evaluated barriers and facilitators to implementing these approaches in real-world settings, particularly during the pre-implementation phase. Pre-implementation assessment is critical for informing the selection and sequencing of implementation strategies and intervention adaptation. Thus, this study sought to understand pre-implementation perceptions of a remote cancer symptom monitoring and management intervention that uses electronic patient-reported outcome measures for symptom assessment. METHODS: We interviewed 20 clinical and administrative stakeholders from 4 geographic regions within an academic medical center and its affiliated health system during the months prior to initiation of a stepped-wedge, cluster randomized pragmatic trial. Transcripts were coded using the Consolidated Framework for Implementation Research [CFIR] 2.0. Two study team members reviewed coded transcripts to understand how determinants were relevant in the pre-implementation phase of the trial and prepared analytic memos to identify themes. RESULTS: Findings are summarized in four themes: (1) ability of the intervention to meet patient needs [recipient characteristics], (2) designing with care team needs in mind [innovation design and adaptability], (3) fit of the intervention with existing practice workflows [compatibility], and (4) engaging care teams early [engaging deliverers]. CONCLUSION: Attention to these aspects when planning intervention protocols can promote intervention compatibility with patients, providers, and practices thereby increasing implementation success.

Rural Health Networks and Care Coordination: Health Care Innovation in Frontier Communities to Improve Patient Outcomes and Reduce Health Care Costs.

Rural residents' health is challenged by high health care costs, chronic diseases, and policy decisions affecting rural health care. This single-case, embedded design study, guided by community-based participatory research principles and using mixed methods, describes outcomes of implementation of a community care team (CCT) and care coordination to improve outcomes of patients living in a frontier community. Seventeen organizations and 165 adults identified as potential care coordination candidates constituted the target populations. Following CCT development, collaboration and cohesion increased among organizations. Patients who participated in care coordination reported similar physical and lower emotional health quality of life than national counterparts; emergency department use decreased following care coordination. Key components identified as successful in urban settings seem applicable in rural settings, with emphasis on the key role of team facilitators; need for intense care coordination for people with complex health needs, especially behavioral health needs; and access to specialty care through technology.