Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies

Abstract

Abstract Background With recent growth in the conduct of pragmatic clinical trials, the reliance on frontline staff to contribute to trial-related activities has grown as well. Active partnerships with staff members are often critical to pragmatic trial implementation, but rarely do research teams track and evaluate the specific “implementation strategies” used to support staff’s involvement in trial procedures (e.g., participant recruitment). Accordingly, we adapted implementation science methodologies and conducted an interim analysis of the strategies deployed with social service staff involved in one multi-site pragmatic clinical trial. Methods We used a naturalistic, observational study design to characterize strategies our research team deployed with staff during monthly, virtual meetings. Data were drawn from meeting notes and recordings from the trial’s 4-month Preparation phase and 8-month Implementation phase. Strategies were mapped to the Expert Recommendations for Implementing Change taxonomy and categorized into nine implementation clusters. Survey data were also collected from staff to identify the most useful strategies the research team should deploy when onboarding new staff members in the trial’s second year. Results A total of 287 strategies were deployed. Strategies in the develop stakeholder interrelationships cluster predominated in both the Preparation (35%) and Implementation (31%) phases, followed by strategies in the use iterative and evaluative approaches cluster, though these were more prevalent during trial Preparation (24%) as compared to trial Implementation (18%). When surveyed on strategy usefulness, strategies in the provide interactive assistance, use financial approaches, and support staff clusters were most useful, per staff responses. Conclusions While strategies to develop stakeholder interrelationships were used most frequently during trial Preparation and Implementation, program staff perceived strategies that provided technical assistance, supported clinicians, and used financial approaches to be most useful and should be deployed when onboarding new staff members. Research teams are encouraged to adapt and apply implementation strategy tracking methods when partnering with social service staff and deploy practical strategies that support pragmatic trial success given staff needs and preferences. Trial registration NCT05357261. May 2, 2022.

Keywords

• Methodology
• Evaluation
• Stakeholder engagement
• Pragmatic clinical trials