GRAMMS.

<div> Background Cluster randomized trials (cRTs) on the effectiveness of training programs face complex challenges when conducted in real-world settings. Process evaluations embedded within cRTs can help explain their results by exploring possible causal mechanisms impacting training effectiveness. Objective To conduct a process evaluation embedded within a cRT by comparing the impact of team-based vs. individual clinician-focused SICP training on primary healthcare professionals’ (PHCPs) intention to have serious illness conversations with patients. Methods The cRT involved 45 primary care practices randomized into a team-based (intervention) or individual clinician-focused (comparator) training program and measured primary outcomes at the patient level: days at home and goals of care. To perform this theory-informed mixed-methods process evaluation embedded within the cRT, a different outcome was measured at the level of the PHCPs, namely, PHCPs’ intention to have serious illness conversations with patients as measured with CPD-Reaction. Barriers and facilitators to implementing the conversations were identified through open-ended questions and analyzed using the Theoretical Domains Framework. The COM-B framework was used to triangulate data. Results were reported using the CONSORT and GRAMMS reporting guidelines. Results Of 535 PHCPs from 45 practices, 373 (69.7%) fully completed CPD-Reaction (30.8% between 25-34 years old; 78.0% women; 54.2% had a doctoral degree; 50.1% were primary care physicians). Mean intention scores for the team-based (n = 223) and individual clinician-focused arms (n = 150) were 5.97 (standard error (SE): 0.11) and 6.42 (SE: 0.13), respectively. Mean difference between arms was 0.0 (95% CI -0.29; 0.30; p = 0.99) after adjusting for age, education and profession. The team-based arm reported barriers with communication, workflow, and more discomfort in having serious illness conversations with patients. Conclusions Team-based training did not outperform individual clinician-focused in influencing PHCPs’ intention to have serious illness conversations. This process evaluation suggests that team-based training could improve intervention effectiveness by focusing on interprofessional communication, better organized workflows, and better support and training for non-clinician team members. <b>Registration</b>: ClinicalTrials.gov (ID: NCT03577002). </div>