Impact of a team-based versus individual clinician-focused training approach on primary healthcare professionals’ intention to have serious illness conversations with patients: a theory informed process evaluation of a cluster randomized trial.

Background: Cluster Randomized Trials (cRTs) conducted in real-world settings face complex challenges due to diverse practices and populations. Process evaluations alongside cRTs can help explain their results by exploring possible causal mechanisms as the trial proceeds. Objective: To conduct a process evaluation alongside a cRT that compared 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 training program (comparator) and measured primary outcomes at the patient level: days at home and goal of care. Our theory-informed mixed-methods process evaluation alongside the cRT measured intention to have serious illness conversations with patients among the trained PHCPs using the CPD-Reaction tool. Barriers and facilitators to implementing serious illness conversations were identified through open-ended questions and analyzed using the Theoretical Domains Framework. We used the COM-B framework to perform triangulation of data. We reported results 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: 0.11) and 6.42 (Standard Error: 0.13), respectively.  Mean difference between arms was 0.0 (95% CI -0.30;0.29; 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. Future team-based interventions could foster behaviour adoption by focusing on interprofessional communication, better organized workflows, and better support and training for non-clinician team members. Registration: ClinicalTrials.gov (ID: [NCT03577002][1]). ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ClinicalTrials.gov (ID: [NCT03577002][1]). ### Clinical Protocols ### Funding Statement Yes ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The parent META-LARC ACP cRT was approved by the Trial Innovation Network Single IRB at Vanderbilt University Medical Center (IRB#181084) for the U.S. sites by the Research Ethics Board of the Centre Intégré Universitaire de Santé et de services sociaux (CIUSSS) de la Capitale-Nationale in Quebec City, Canada (ethics number #MP-13-2019-1526), for the sites in Quebec and by the Health Sciences Research Ethics Board of the University of Toronto (protocol number 36631), for the sites in Ontario. The process evaluation's data and outcomes were included in the approval. All subjects willingly agreed to take part in the study, and their consent was obtained in accordance with the regulations of the Institutional Review Board or Research Ethics Board in effect. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All relevant data are within the manuscript and its Supporting Information files. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03577002&atom=%2Fmedrxiv%2Fearly%2F2024%2F02%2F07%2F2024.02.05.24302368.atom