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

Abstract Background 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 men...

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Main Authors: Defang Xiang, Xian Xia, Di Liang
Format: Article
Language:English
Published: BMC 2023-11-01
Series:BMC Primary Care
Subjects:
Online Access:https://doi.org/10.1186/s12875-023-02179-2
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author Defang Xiang
Xian Xia
Di Liang
author_facet Defang Xiang
Xian Xia
Di Liang
author_sort Defang Xiang
collection DOAJ
description Abstract Background 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. Methods 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. Discussion 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. Trial registration ChiCTR2300072559. Registered on 16 June 2023.
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spelling doaj.art-4f9e93fde3934958a400f5474da3b1162023-11-05T12:25:34ZengBMCBMC Primary Care2731-45532023-11-0124111310.1186/s12875-023-02179-2Developing and evaluating an interprofessional shared decision-making care model for patients with perinatal depression in maternal care in urban China: a study protocolDefang Xiang0Xian Xia1Di Liang2School of Public Health, National Health Commission Key Laboratory of Health Technology Assessment, Fudan UniversityObstetrics and Gynecology Hospital of Fudan UniversitySchool of Public Health, National Health Commission Key Laboratory of Health Technology Assessment, Fudan UniversityAbstract Background 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. Methods 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. Discussion 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. Trial registration ChiCTR2300072559. Registered on 16 June 2023.https://doi.org/10.1186/s12875-023-02179-2Perinatal depressionShared decision-makingDecision aidParticipatory designQualitative methodsRCT
spellingShingle Defang Xiang
Xian Xia
Di Liang
Developing and evaluating an interprofessional shared decision-making care model for patients with perinatal depression in maternal care in urban China: a study protocol
BMC Primary Care
Perinatal depression
Shared decision-making
Decision aid
Participatory design
Qualitative methods
RCT
title Developing and evaluating an interprofessional shared decision-making care model for patients with perinatal depression in maternal care in urban China: a study protocol
title_full Developing and evaluating an interprofessional shared decision-making care model for patients with perinatal depression in maternal care in urban China: a study protocol
title_fullStr Developing and evaluating an interprofessional shared decision-making care model for patients with perinatal depression in maternal care in urban China: a study protocol
title_full_unstemmed Developing and evaluating an interprofessional shared decision-making care model for patients with perinatal depression in maternal care in urban China: a study protocol
title_short Developing and evaluating an interprofessional shared decision-making care model for patients with perinatal depression in maternal care in urban China: a study protocol
title_sort developing and evaluating an interprofessional shared decision making care model for patients with perinatal depression in maternal care in urban china a study protocol
topic Perinatal depression
Shared decision-making
Decision aid
Participatory design
Qualitative methods
RCT
url https://doi.org/10.1186/s12875-023-02179-2
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