Abstract
OBJECTIVES: To assess the feasibility and preliminary effectiveness of 'Partners for Patient Safety' (P4PS) programme for strengthening competencies and patient engagement at the organisational level. DESIGN: Prospective study with three measurement points (baseline, interim and follow-up) and an explanatory sequential mixed methods approach for formative and process evaluation. SETTING: Oncology-focused patient and family advisory councils (PFACs) integrated into healthcare organisations and networks in five German federal states. PARTICIPANTS: Initially, 36 stakeholders of six PFACs were recruited. At follow-up, 27 participated in all intervention modules and completed all surveys. From those, 14 participated in follow-up interviews. INTERVENTION: The P4PS programme consists of two sequentially implemented modules: (1) an e-learning module and (2) a 4-hour on-site workshop. The programme focuses on the following topics: patient safety (PS), communication strategies and PFAC engagement in respective care organisations. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome measures were feasibility domains, assessed via standardised (acceptability, appropriateness, feasibility) and self-developed measures (relevance, acceptability and social validity, complexity and practicability, demand and implementation, and adaptability). Secondary outcome measure was preliminary effectiveness, measured via changes in self-assessed competencies in PS, communication and engagement. RESULTS: Feasibility ratings were high across standardised and self-developed measures (median range: 4-5 of 5). Qualitative data showed P4PS programme's practical relevance, need for organisational support and its adaptability across PFAC contexts. Effectiveness analyses showed significant improvements in PS competencies (adjusted p<0.01, Wilcoxon's V) and selected domains of PFAC engagement (adjusted p<0.05), while changes in communication skills were not statistically significant. Effect sizes ranged from moderate to large (Cohen's d=-0.77 to -1.37). Participants expressed strong expectations for future improvements in competencies regarding PS, communication and PFAC engagement. CONCLUSIONS: This P4PS programme showed high feasibility and effectiveness, it increased key competencies, clarified roles and promoted active PFAC engagement in PS. Future work needs to address organisational support and sustainable implementation with application to context as well as long-term evaluation across different care settings. TRIAL REGISTRATION NUMBER: DRKS00034733; German Clinical Trials Register.