The University of Sydney, The School of Psychology, Sydney, NSW, 2006, Australia.
The University of Sydney, The Matilda Centre for Research in Mental Health and Substance Use, Sydney, NSW, 2006, Australia.
BMC Psychiatry. 2020 Sep 17;20(1):447. doi: 10.1186/s12888-020-02845-0.
Many patients with bipolar II disorder (BPII) prefer to be more informed and involved in their treatment decision-making than they currently are. Limited knowledge and involvement in one's treatment is also likely to compromise optimal BPII management. This Phase II RCT aimed to evaluate the acceptability, feasibility, and safety of a world-first patient decision-aid website (e-DA) to improve treatment decision-making regarding options for relapse prevention in BPII. The e-DA's potential efficacy in terms of improving quality of the decision-making process and quality of the decision made was also explored.
The e-DA was based on International Patient Decision-Aid Standards and developed via an iterative co-design process. Adults with BPII diagnosis (n = 352) were recruited through a specialist outpatient clinical service and the social media of leading mental health organisations. Participants were randomised (1:1) to receive standard information with/without the e-DA (Intervention versus Control). At baseline (T0), post-treatment decision (T1) and at 3 months' post-decision follow-up (T2), participants completed a series of validated and purpose-designed questionnaires. Self-report and analytics data assessed the acceptability (e.g., perceived ease-of-use, usefulness; completed by Intervention participants only), safety (i.e., self-reported bipolar and/or anxiety symptoms), and feasibility of using the e-DA (% accessed). For all participants, questionnaires assessed constructs related to quality of the decision-making process (e.g., decisional conflict) and quality of the decision made (e.g., knowledge of treatment options and outcomes).
Intervention participants endorsed the e-DA as acceptable and feasible to use (82.1-94.6% item agreement); most self-reported using the e-DA either selectively (51.8%; relevant sections only) or thoroughly (34%). Exploratory analyses indicated the e-DA's potential efficacy to improve decision-making quality; most between-group standardised mean differences (SMD) were small-to-moderate. The largest potential effects were detected for objective treatment knowledge (- 0.69, 95% CIs - 1.04, - 0.33 at T1; and - 0.57, 95% CIs - 0.99,-0.14 at T2), decisional regret at T2 (0.42, 95% CIs 0.01, 0.84), preparation for decision-making at T1 (- 0.44, 95% CIs - 0.81, - 0.07), and the Decisional Conflict Scale Uncertainty subscale (0.42, 95% CIs 0.08, 0.08) and Total (0.36, 95% CIs 0.30, 0.69) scores, with all SMDs favouring the Intervention over the Control conditions. Regarding safety, e-DA use was not associated with worse bipolar symptoms or anxiety.
The e-DA appears to be acceptable, feasible, safe and potentially efficacious at improving patients' decision-making about BPII treatment. Findings also support the future adoption of the e-DA into patient care for BPII to foster treatment decisions based on the best available evidence and patient preferences.
Australian New Zealand Clinical Trials Registry ACTRN12617000840381 (prospectively registered 07/06/2017).
许多双相情感障碍 II 型（BPII）患者希望在治疗决策中比目前更知情并参与。有限的知识和对治疗的参与也可能影响 BPII 的最佳管理。这项 II 期 RCT 旨在评估一种世界首创的患者决策辅助网站（e-DA）在改善 BPII 复发预防选择方面的可接受性、可行性和安全性。该 e-DA 在改善决策过程质量和所做决策质量方面的潜在疗效也进行了探讨。
该 e-DA 基于国际患者决策辅助标准，并通过迭代共同设计过程开发。通过专门的门诊临床服务和领先的心理健康组织的社交媒体，招募了 352 名 BPII 诊断的成年人（n=352）。参与者被随机（1:1）分为接受标准信息加/不加 e-DA（干预组与对照组）。在基线（T0）、治疗决策后（T1）和决策后 3 个月随访（T2），参与者完成了一系列经过验证和专门设计的问卷。自我报告和分析数据评估了可接受性（例如，感知易用性、有用性；仅干预组参与者完成）、安全性（即自我报告的双相和/或焦虑症状）和使用 e-DA 的可行性（%访问）。对于所有参与者，问卷评估了与决策过程质量相关的构建（例如，决策冲突）和所做决策质量（例如，治疗方案和结果的知识）。
干预组参与者认为 e-DA 是可以接受的，并且易于使用（82.1-94.6%的项目一致性）；大多数自我报告选择性（51.8%；仅相关部分）或全面（34%）使用 e-DA。探索性分析表明，e-DA 具有改善决策质量的潜在疗效；大多数组间标准化平均差异（SMD）较小至中等。最大的潜在效果是观察到客观治疗知识的改善（T1 时为-0.69，95%CI -1.04，-0.33；T2 时为-0.57，95%CI -0.99，-0.14）、T2 时的决策后悔（0.42，95%CI 0.01，0.84）、T1 时的决策准备（-0.44，95%CI -0.81，-0.07）和决策冲突量表不确定亚量表（0.42，95%CI 0.08，0.08）和总量表（0.36，95%CI 0.30，0.69）评分，所有 SMD 均有利于干预组。关于安全性，e-DA 的使用与双相症状或焦虑症状的恶化无关。
e-DA 在改善 BPII 治疗决策方面似乎是可以接受的、可行的、安全的和潜在有效的。研究结果还支持未来将 e-DA 纳入 BPII 患者护理中，以基于最佳现有证据和患者偏好来促进治疗决策。
澳大利亚新西兰临床试验注册处 ACTRN12617000840381（2017 年 7 月 6 日前瞻性注册）。
