Evaluation of the effectiveness and cost-effectiveness of psychological first aid (PFA) system based training for frontline health workers in emergency health services in China a study protocol of a cluster randomized controlled trial

INTRODUCTION: There is insufficient evidence on the effectiveness and cost-effectiveness of psychological interventions to enhance frontline responders’ mental health proficiency and competence in emergency settings. This paper describes the methods for the evaluation of the effectiveness and cost-effectiveness of Psychological First Aid training, to determine whether the intervention is effective and cost-effective as a mental health intervention in public health emergencies. A pilot to evaluate the acceptability of the PFA training found participants were either satisfied (55.6%) or extremely satisfied (44.4%) with the training program. METHOD: This paper describes the protocol for a cluster randomized two-arm controlled trial. A total of 1,399 non-specialist health care workers will be recruited in 42 hospitals and health care centers across six provinces in China. Participants will be assigned according to hospital or health care center site to one of two groups (n = 699 for intervention group and 709 for control group) to receive system based PFA training or PFA training as usual. Both groups will receive one-day of training, comprising six modules including PFA core concepts, knowledge, skills and practice. Their knowledge, skills, competency, self-efficacy, resilience, and professional quality of life will be assessed immediately after the training; and reassessed after 1 and 2 months. ANALYSIS: For effectiveness outcomes, repeated measures will be used in a multi-level linear mixed model. The pooled standard deviations will be used to calculate the effect sizes (Cohen’s d) within and between groups. Appropriate statistical tests will be used to explore differences between intervention and control groups. For economic outcomes, a health service sector perspective will be adopted, with intervention costs and outcomes collected prospectively. Within-trial cost-effectiveness analysis (CEA) will quantify the incremental costs and PFA proficiency gains of the intervention compared with training as usual at 2 months post training. CEA will present results as cost per unit of mental health proficiency gained. A cost-utility analysis (CUA) model will extend the population to emergency health service users.in order to identify potential for incremental cost offsets attributable to mental health improvement arising from intervention. Intervention costs and effects will be extrapolated to the population of patients who receive the emergency health service in clinical wards and will be modeled over the cohort’s lifetime. Modeled CUA results will be calculated as quality-adjusted life-years saved and healthcare cost savings in preventing mental disorders. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Second Xiangya Hospital, Central South University Clinical Research Ethics Committee (2021) Ethical Review [Clinical Research] #067). Data about the economic evaluation of the intervention will be stored in the KCL OneDrive at King’s College London, UK. The trial protocol was registered with the China Clinical Trials Registry: ChiCTR2200060464. Study findings will be disseminated through peer-reviewed academic papers, and participating hospitals.