A protocol for stakeholder engagement in deliver-EE: A pragmatic randomized comparative effectiveness trial evaluating effects of meal delivery on the ability of homebound older adults to remain in the community.

BACKGROUND: Few clinical trials include a detailed protocol for stakeholder engagement in the design and execution of the clinical trial. Deliver-EE is a pragmatic clinical trial to assess how different types of home-delivered meals can affect older adults' health and well-being. We present the protocol for stakeholder engagement in this national, multi-site trial and initial findings from our efforts. METHODS: Twenty-nine participants were recruited to two stakeholder advisory panels. The "Lived Experience Perspectives" panel is defined as the clients, caregivers, and meal delivery drivers with first-hand knowledge and lived experiences with meal delivery. The "System Perspectives" panel is defined as representatives from the larger financial, clinical, regulatory, and operational environments in which meal delivery to homebound older adults operate. Together, these two groups holistically represent interested parties that coordinate the interdependent elements of meal delivery to homebound older adults in order to: 1) inform our understanding of what matters most to older adults, their families, and the larger health and social care systems; 2) provide strategies to overcome challenges conducting the study; 3) enhance dissemination and uptake of study findings; and 4) identify opportunities for future research. RESULTS: Although stakeholder partners share a common goal of using home-delivered meals as a method to improve outcomes for homebound older adults, individuals have different goals for participating as advisors in this research. CONCLUSIONS: Understanding what individual stakeholders hope to gain from their participation is critical in designing an effective engagement protocol and critical for meaningful and rigorous stakeholder engagement in clinical trials.

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

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.