CHU Clermont-Ferrand, Department of Psychiatry, University of Clermont Auvergne, EA7280, Clermont-Ferrand, France.
Aix-Marseille University, Public Health, Chronic Diseases and Quality of Life research Unit, EA 3279, Marseille, France.
BMC Psychiatry. 2018 Apr 13;18(1):103. doi: 10.1186/s12888-018-1686-y.
Shared decision-making (SDM) is a model of interaction between doctors and patients in which both actors contribute to the medical decision-making process. SDM has raised great interest in mental healthcare over the last decade, as it is considered a fundamental part of patient-centered care. However, there is no research evaluating the efficacy of SDM compared to usual care (CAU), as it relates to quality of care and more specifically treatment adherence, in bipolar disorder (BD).
METHODS/DESIGN: This is a 12-month multi-centre, cluster-randomized controlled trial comparing the efficacy of SDM to CAU. Adult BD patients (n = 300) will be eligible after stabilization for at least 4 weeks following an acute mood episode. The intervention will consist of applying the standardized SDM process as developed by the Ottawa Hospital Research Institute in order to choose the maintenance treatment of BD. A multidisciplinary team developed a decision aid "choose my long-term treatment with my doctor" for BD patients to clarify possible therapeutic options. Primary outcome will assess the patient's level of adherence (based on hetero-evaluation) of ongoing treatment at 12 months. Secondary outcomes will assess the difference between the 2 groups of patients in terms of adherence to maintenance drug therapy based on other measures (self-assessment scale and plasma levels of mood stabilizers). Additionally, other dimensions will be assessed: decisional conflict, satisfaction with care and involvement in decision making, beliefs about treatment, therapeutic relationship, knowledge about information for medical decision and clinical outcomes (depression, mania, functioning and quality of life). The primary endpoint will be analysed without adjustment by comparison of adherence scores between the two groups using Student t-tests or Mann-Whitney tests according to the variable distribution. A set of secondary analyses will be adjusted for covariates of clinical interest using generalized linear mixed regression models.
This will be the first study evaluating the effect of an SDM intervention on patient adherence in BD. This is also an innovative protocol because it proposes the development of an evidence-based tool that should help patients and clinicians to initiate discussions regarding the use of BD treatment.
The study has been registered with ClinicalTrials.gov as NCT03245593 .
共享决策（SDM）是一种医患互动模式，医生和患者都为医疗决策过程做出贡献。SDM 在过去十年中在精神卫生保健领域引起了极大的兴趣，因为它被认为是以患者为中心的护理的基本组成部分。然而，目前还没有研究评估 SDM 与常规护理（CAU）相比在双相情感障碍（BD）中与护理质量相关的治疗依从性的疗效。
方法/设计：这是一项为期 12 个月的多中心、集群随机对照试验，比较 SDM 与 CAU 的疗效。在急性情绪发作后至少稳定 4 周后，符合条件的成年 BD 患者（n=300）将有资格参与。干预措施将包括应用渥太华医院研究所制定的标准化 SDM 流程，以选择 BD 的维持治疗。一个多学科团队为 BD 患者开发了一个决策辅助工具“与我的医生一起选择我的长期治疗”，以澄清可能的治疗选择。主要结局是在 12 个月时评估患者对正在进行的治疗的依从性（基于异质性评估）。次要结局将评估两组患者在维持药物治疗依从性方面的差异，基于其他措施（自我评估量表和心境稳定剂的血浆水平）。此外，还将评估其他维度：决策冲突、对护理的满意度和对决策的参与、对治疗的信念、治疗关系、用于医疗决策的信息知识和临床结果（抑郁、躁狂、功能和生活质量）。主要终点将在不进行调整的情况下进行分析，比较两组之间的依从性评分，使用学生 t 检验或曼-惠特尼检验，根据变量分布。一组次要分析将使用广义线性混合回归模型，针对临床相关的协变量进行调整。
这将是第一项评估 SDM 干预对 BD 患者依从性影响的研究。这也是一项创新的方案，因为它提出了开发一种基于证据的工具，这应该有助于患者和临床医生启动关于 BD 治疗使用的讨论。
该研究已在 ClinicalTrials.gov 上注册，注册号为 NCT03245593。
