Developing and evaluating an interprofessional shared decision-making care model for patients with perinatal depression in maternal care in urban China: a study protocol

BackgroundThe majority of patients with perinatal depression (PND) in China do not receive adequate treatment. As forming a therapeutic alliance with patients is crucial for depression treatment, shared decision-making (SDM) shows promise in promoting patients' uptake of evidence-based mental health services, but its impact on patient outcomes and implementation in real-world maternal care remain uncertain. Therefore, this study aims to develop and evaluate an interprofessional shared decision-making (IP-SDM) model for PND to enhance maternal mental health services.MethodsThis study contains four research phases: feasibility testing (Phase 1), toolkit development (Phase 2), usability evaluation (Phase 3), and effectiveness evaluation (Phase 4). During the development stage, focus group interviews will be conducted with expectant and new mothers, as well as maternal care providers for feasibility testing. A toolkit, including a patient decision aid along with its user guide and training materials, will be developed based on the findings of Phase 1 and syntheses of up-to-date evidence and appraised by the Delphi method. Additionally, a cognitive task analysis will be used for assessing the usability of the toolkit. During the evaluation stage, a prospective randomized controlled trial embedded in a mixed methods design will be used to evaluate the effectiveness and cost-effectiveness of the IP-SDM care model. The study targets to recruit 410 expectant and new mothers who screen positive for depression. They will be randomly assigned to either an intervention group or a control group in a 1:1 ratio. Participants in the intervention group will receive decision aid, decision coaching, and clinical consultation, in addition to usual services, while the control group will receive usual services. The primary outcome is the quality of decision-making process, and the secondary outcomes include SDM, mental health service utilization and costs, depressive symptoms, and health-related quality of life. In-depth interviews will be used to explore the facilitating and hindering factors of SDM.DiscussionThis study will develop an IP-SDM care model for PND that can be implemented in maternal care settings in China. This study will contribute to the understanding of how SDM impacts mental health outcomes and facilitate the integration of mental health services into maternal care.Trial registrationChiCTR2300072559. Registered on 16 June 2023. This study aims to develop a culturally relevant and responsive IP-SDM care model for PND that can be implemented in maternal care settings in China. For instance, the IP-SDM model will involve family members in the decision-making process between patients and providers.This study will contribute to the understanding of how SDM impacts mental health outcomes. This study will not only investigate the effects of SDM on mental health outcomes but also explore the potential mechanisms underlying such impacts, using causal mediation analysis.Lastly, this study will conduct a randomized controlled trial design to evaluate the effectiveness and cost-effectiveness of the care model, providing evidence for implementing SDM in clinical practice within the context of integrated mental health services.