Primary outcome measures

To assess the implementability of the intervention

Concerning the implementation, we will assess the implementation platform for the intervention by assessing fidelity (if and to what extent the intervention was performed as planned and the educational recommendations were followed) and barriers and facilitators for implementation concerning, e.g., comprehensibility, acceptability by practices, preparation, and the integration of the intervention into existing practices. This will be done by performing qualitative semi-structured interviews with general practitioners and staff in the intervention group during the pilot trial and observations of the introductory course and prolonged consultations.

To assess the feasibility of the design in terms of recruitment of practices and patients and assess retention of patients during the intervention

The feasibility of the recruitment of practices and patients will be assessed using the proportion of contacted general practices, which agree to participate in the study and the eligibility and consent rate of patients. We consider a participation rate of at least 20% of the contacted general practices and at least 60% of the contacted patients as an indication that our recruitment strategy is feasible. Based on registrations by the practices in REDCap, feedback and questions regarding support from practices during the process, and interviews with general practitioners and staff after the recruitment process, we will assess the appropriateness of the recruitment process and the introduction and support to the participating practices.

Retention of patients will be assessed as the proportion of recruited patients in the intervention group who attend the first consultation, and the minimum threshold for attendance is set at 90%. Information on measures such as non-return of consent forms, non-shows by participating patients in general practice, and difficulties reaching patients will be collected. Based on interviews with the practices, we will explore their work related to ensuring patient attendance.

To assess the feasibility of collection of outcome measures and thereby obtain preliminary data to inform the required sample size in the definitive trial

All patients, regardless of allocation, will complete the two outcome questionnaires the MMQ and the EQ-5D-5L questionnaire at baseline, after randomization, and at the end of the pilot trial. Based on the number of returned questionnaires, we will calculate response rates and the proportion of missing data in each completed questionnaire. We set a minimum acceptable threshold for the response rate before randomization of both questionnaires at >90% with a maximum proportion of missing data at <10%. We set a minimally acceptable response rate at >90% for both questionnaires at the end of the study period in both the intervention and the control group.

Data on mortality and in- and outpatient admissions during the study period in the participating patients will be collected from the national patient registries after completion of the pilot trial. These data, along with the scores of the MMQ, and the EQ-5D-5L questionnaires, will be used to estimate the necessary sample size to power the definitive trial, which primary endpoints are mortality and quality of life, as measured by the MMQ.