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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Format: | Article |
Language: | English |
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BMC
2023-11-01
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Series: | BMC Primary Care |
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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. |
first_indexed | 2024-03-11T12:38:36Z |
format | Article |
id | doaj.art-4f9e93fde3934958a400f5474da3b116 |
institution | Directory Open Access Journal |
issn | 2731-4553 |
language | English |
last_indexed | 2024-03-11T12:38:36Z |
publishDate | 2023-11-01 |
publisher | BMC |
record_format | Article |
series | BMC Primary Care |
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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