Competence Centre for Rehabilitation and Recovery, The Mental Health Centre Ballerup, The Mental Health Services of the Capital Region, Ballerup, Denmark.
Psychiatric Research Unit, Region Zealand Psychiatry, Slagelse, Denmark.
BMC Psychiatry. 2019 Jun 17;19(1):185. doi: 10.1186/s12888-019-2143-2.
BACKGROUND: Shared decision making (SDM) is often defined as an interactive process that ensures that both patient and practitioner are actively involved in the treatment and that they share all relevant information to arrive at a mental health decision. Previous SDM interventions have found improvements in outcomes such as personal recovery, higher perceived involvement in treatment decisions and knowledge about one's disease. Still, SDM occurs less frequently in mental health care than in primary care. Electronic aids developed to support patient activation and SDM could be a promising mean to engage patients in their mental healthcare. The aim of this trial is to investigate the effects of using a smartphone app to promote patient activation and support SDM for people with schizophrenia-spectrum disorders in an outpatient treatment setting. METHODS: This randomised controlled trial will allocate participants to one of two groups: (1) Intervention group: smartphone app and TAU (treatment as usual) or (2) Control group: TAU without the smartphone app. A total sample size of 260 people with a diagnosis of schizophrenia, schizotypal or delusional disorder will be recruited from five OPUS teams (a specialized early intervention program) in Denmark between 2019 and 2020. The intervention will last for 6 months with data collection at baseline, and at 3 and 6 months. Primary outcome will be self-perceived patient activation. Secondary outcomes will be feeling of being prepared for SDM; self-efficacy; working alliance; treatment satisfaction; positive and negative symptoms; level of functioning; hope; and perceived efficacy in patient-provider interaction. Patients' and health providers' preferences in clinical decision making will be assessed. Patients' usage and perceived usefulness of the app will be explored. DISCUSSION: This study will investigate the efficacy of using the smartphone app to support people with severe mental illness in engaging in their own healthcare management. The study may provide evidence to the idea that linking client and practitioner in digital solutions can have advantages in facilitating SDM in mental health. The trial will provide new knowledge of whether a digital healthcare solution can improve patient activation and support SDM for people with severe mental illness. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT03554655 Registered on: June 13, 2018.
背景:共同决策(SDM)通常被定义为一个互动过程,确保患者和医生都积极参与治疗,并共享所有相关信息,以做出心理健康决策。先前的 SDM 干预措施发现,在个人康复、治疗决策的感知参与度和对疾病的认识等方面都有所改善。尽管如此,SDM 在精神卫生保健中的发生率仍低于初级保健。为了支持患者的积极性和 SDM 而开发的电子辅助工具可能是一种很有前途的方法,可以让患者参与到他们的精神保健中。本试验的目的是研究在门诊治疗环境中使用智能手机应用程序来促进精神分裂症谱系障碍患者的患者积极性和支持 SDM 的效果。
方法:这项随机对照试验将参与者分配到以下两个组之一:(1)干预组:智能手机应用程序和 TAU(常规治疗)或(2)对照组:没有智能手机应用程序的 TAU。将从丹麦的五个 OPUS 团队(一个专门的早期干预计划)招募 260 名被诊断为精神分裂症、类精神分裂症或妄想障碍的患者,招募时间为 2019 年至 2020 年。干预将持续 6 个月,在基线、3 个月和 6 个月时进行数据收集。主要结果将是自我感知的患者积极性。次要结果将是对 SDM 的准备感、自我效能感、工作联盟、治疗满意度、阳性和阴性症状、功能水平、希望和患者-提供者互动的感知效能。将评估患者和卫生保健提供者对临床决策的偏好。将探讨患者对应用程序的使用情况和感知有用性。
讨论:本研究将调查使用智能手机应用程序支持严重精神疾病患者参与自身医疗保健管理的效果。该研究可能为以下观点提供证据,即将客户和医生联系在数字解决方案中可能具有在促进精神卫生保健中的 SDM 的优势。该试验将提供新的知识,即数字医疗解决方案是否可以提高严重精神疾病患者的患者积极性并支持 SDM。
试验注册:ClinicalTrials.gov 编号:NCT03554655 注册日期:2018 年 6 月 13 日。
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