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/.
ABSTRACT
The objective was to determine if a greater proportion of physician full-time equivalent (FTE%) relative to nurse practitioners/physician assistants (NPs/PAs) on care teams was associated with improved individual clinician diabetes quality outcomes. The authors conducted a retrospective cross-sectional study of 420 family medicine clinicians in 110 care teams in a Midwest health system, using administrative data from January 1, 2017 to December 31, 2017. Poisson regression was used to examine the relationship between physician FTE% and the number of patients meeting 5 criteria included in a composite metric for diabetes management (D5). Covariates included panel size, clinician type, sex, years in practice, region, patient satisfaction, care team size, rural location, and panel complexity. Of the 420 clinicians, 167 (40%) were NP/PA staff and 253 (60%) were physicians. D5 criteria were achieved in 37.9% of NP/PA panels compared with 44.5% of physician panels (P < .001). In adjusted analysis, rate of patients achieving D5 was unrelated to physician FTE% on the care team (P = .78). Physicians had a 1.082 (95% confidence interval 1.007-1.164) times greater rate of patients with diabetes achieving D5 than NPs/PAs. Clinicians at rural locations had a .904 (.852-.959) times lower rate of achieving D5 than those at urban locations. Physicians had a greater rate of patients achieving D5 compared with NPs/PAs, but physician FTE% on the care team was unrelated to D5 outcomes. This suggests that clinician team composition matters less than team roles and the dynamics of collaborative care between members.