PDF(Pubmed)
Abstract：
The 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.
This 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.
This 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.
ChiCTR2300072559. Registered on 16 June 2023.
This 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.
This 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.
ChiCTR2300072559. Registered on 16 June 2023.
摘要：
背景：中国大多数围产期抑郁症（PND）患者没有接受适当的治疗。与患者形成治疗联盟对于抑郁症治疗至关重要，共享决策(SDM)在促进患者接受循证精神卫生服务方面显示出希望，但其对患者结局和现实孕产妇护理实施的影响仍不确定.因此,这项研究旨在开发和评估PND的跨专业共享决策（IP-SDM）模型，以增强孕产妇的心理健康服务。
方法：本研究包含四个研究阶段：可行性测试（第一阶段），工具包开发（第二阶段），可用性评估（第3阶段），和有效性评估（第4阶段）。在发展阶段,焦点小组访谈将与准妈妈和新妈妈进行，以及产妇护理提供者进行可行性测试。一个工具包，包括患者决策辅助工具及其用户指南和培训材料，将根据第一阶段的调查结果和最新证据的综合结果进行开发，并通过德尔菲法进行评估。此外,认知任务分析将用于评估工具包的可用性。在评估阶段，纳入混合方法设计的前瞻性随机对照试验将用于评估IP-SDM护理模式的有效性和成本效益.该研究的目标是招募410名抑郁症筛查阳性的准妈妈和新妈妈。他们将以1：1的比例随机分配到干预组或对照组。干预组的参与者将获得决策援助，决策指导，和临床咨询，除了常规服务，而对照组将接受常规服务。主要结果是决策过程的质量，次要结果包括SDM，精神卫生服务利用和成本，抑郁症状,和健康相关的生活质量。深入访谈将用于探索SDM的促进和阻碍因素。
结论：本研究将开发一种针对PND的IP-SDM护理模式，该模式可在中国的孕产妇护理机构中实施。这项研究将有助于了解SDM如何影响心理健康结果，并促进将心理健康服务纳入孕产妇护理。
背景：ChiCTR2300072559。2023年6月16日注册。
方法：本研究包含四个研究阶段：可行性测试（第一阶段），工具包开发（第二阶段），可用性评估（第3阶段），和有效性评估（第4阶段）。在发展阶段,焦点小组访谈将与准妈妈和新妈妈进行，以及产妇护理提供者进行可行性测试。一个工具包，包括患者决策辅助工具及其用户指南和培训材料，将根据第一阶段的调查结果和最新证据的综合结果进行开发，并通过德尔菲法进行评估。此外,认知任务分析将用于评估工具包的可用性。在评估阶段，纳入混合方法设计的前瞻性随机对照试验将用于评估IP-SDM护理模式的有效性和成本效益.该研究的目标是招募410名抑郁症筛查阳性的准妈妈和新妈妈。他们将以1：1的比例随机分配到干预组或对照组。干预组的参与者将获得决策援助，决策指导，和临床咨询，除了常规服务，而对照组将接受常规服务。主要结果是决策过程的质量，次要结果包括SDM，精神卫生服务利用和成本，抑郁症状,和健康相关的生活质量。深入访谈将用于探索SDM的促进和阻碍因素。
结论：本研究将开发一种针对PND的IP-SDM护理模式，该模式可在中国的孕产妇护理机构中实施。这项研究将有助于了解SDM如何影响心理健康结果，并促进将心理健康服务纳入孕产妇护理。
背景：ChiCTR2300072559。2023年6月16日注册。
