Fisher Alana, Sharpe Louise, Costa Daniel, Anderson Josephine, Manicavasagar Vijaya, Juraskova Ilona
School of Psychology, Brennan MacCallum Building (A18), The University of Sydney, NSW, 2006, Australia.
Centre for Medical and Evidence-based Decision-making (CeMPED), Level 6, Chris O'Brien Lifehouse (C39Z), The University of Sydney, NSW, 2006, Australia.
Contemp Clin Trials Commun. 2018 Nov 9;12:137-144. doi: 10.1016/j.conctc.2018.11.004. eCollection 2018 Dec.
BACKGROUND/AIMS: This paper describes the protocol for a feasibility study for a parallel Phase II randomised control trial (RCT) aiming to evaluate a novel decision-aid website (e-DA) to support young adults with bipolar II disorder (BPII), and their families.
The e-DA was developed according to the International Patient Decision-Aid Standards (IPDAS). Participants will be 40 young adults (18-30 years) referred to a specialist outpatient clinical facility, who have a confirmed clinical diagnosis of BPII. Participants will be randomised (1:1) to receive access to the clinic's online factsheets/website with (Intervention) or without (Control) the e-DA. A series of validated and purpose-designed questionnaires will be administered at baseline (T0), immediately post-decision (T1), and 3 months post-decision (T2). Questionnaires assess key decision-making constructs related to decision-making quality, including: decisional conflict, subjective and objective treatment knowledge, values-based informed choice, concordance between preferred/actual decision-making involvement, preparation for decision-making, and decisional regret. Self-report symptom severity and anxiety will ascertain the safety of e-DA use. The focus of analyses will be to assess effect sizes, in order to guide a future RCT.
This feasibility study will evaluate a world first, evidence-based online decision-support resource, a DA website, for young adults with BPII and their families who are deciding on treatment options for relapse prevention. Findings will determine the e-DA's feasibility in RCT procedures (i.e., outpatient clinical setting) and provide estimates of effect sizes on outcomes related to improving treatment decision-making and patient outcomes in a sample of potential end-users, compared to usual care.
This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12617000840381.
背景/目的：本文描述了一项平行二期随机对照试验（RCT）可行性研究的方案，旨在评估一个新型决策辅助网站（电子决策辅助工具，e-DA），以支持双相II型障碍（BPII）的青年及其家庭。
电子决策辅助工具是根据国际患者决策辅助标准（IPDAS）开发的。参与者将是40名年龄在18至30岁之间、被转诊至专科门诊临床机构且临床确诊为BPII的青年。参与者将被随机分配（1:1），分别获得访问诊所带有（干预组）或不带有（对照组）电子决策辅助工具的在线情况说明书/网站的权限。一系列经过验证且专门设计的问卷将在基线（T0）、决策后即刻（T1）和决策后3个月（T2）进行发放。问卷评估与决策质量相关的关键决策构建，包括：决策冲突、主观和客观治疗知识、基于价值观的知情选择、偏好/实际决策参与之间的一致性、决策准备以及决策后悔。自我报告的症状严重程度和焦虑情况将确定使用电子决策辅助工具的安全性。分析重点将是评估效应大小，以指导未来的随机对照试验。
这项可行性研究将评估首个基于证据的在线决策支持资源，即一个针对BPII青年及其家庭在决定预防复发治疗方案时使用的决策辅助网站。研究结果将确定电子决策辅助工具在随机对照试验程序（即门诊临床环境）中的可行性，并与常规护理相比，提供在潜在最终用户样本中对改善治疗决策和患者结局相关结果的效应大小估计。
本试验已在澳大利亚新西兰临床试验注册中心（ANZCTR）注册 - ACTRN12617000840381。
