Competence Center for Rehabilitation and Recovery, Mental Health Center Ballerup, Mental Health Services in the Capital Region of Denmark, Ballerup, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
J Med Internet Res. 2022 Oct 26;24(10):e40292. doi: 10.2196/40292.
Shared decision-making (SDM) is a process aimed at facilitating patient-centered care by ensuring that the patient and provider are actively involved in treatment decisions. In mental health care, SDM has been advocated as a means for the patient to gain or regain control and responsibility over their life and recovery process. To support the process of patient-centered care and SDM, digital tools may have advantages in terms of accessibility, structure, and reminders.
In this randomized controlled trial, we aimed to investigate the effect of a digital tool to support patient activation and SDM.
The trial was designed as a randomized, assessor-blinded, 2-armed, parallel-group multicenter trial investigating the use of a digital SDM intervention for 6 months compared with treatment as usual. Participants with a diagnosis of schizophrenia, schizotypal or delusional disorder were recruited from 9 outpatient treatment sites in the Capital Region of Denmark. The primary outcome was the self-reported level of activation at the postintervention time point. The secondary outcomes included self-efficacy, hope, working alliance, satisfaction, preparedness for treatment consultation, symptom severity, and level of functioning. Explorative outcomes on the effect of the intervention at the midintervention time point along with objective data on the use of the digital tool were collected.
In total, 194 participants were included. The intention-to-treat analysis revealed a statistically significant effect favoring the intervention group on patient activation (mean difference 4.39, 95% CI 0.99-7.79; Cohen d=0.33; P=.01), confidence in communicating with one's provider (mean difference 1.85, 95% CI 0.01-3.69; Cohen d=0.24; P=.05), and feeling prepared for decision-making (mean difference 5.12, 95% CI 0.16-10.08; Cohen d=0.27; P=.04). We found no effect of the digital SDM tool on treatment satisfaction, hope, self-efficacy, working alliance, severity of symptoms, level of functioning, use of antipsychotic medicine, and number or length of psychiatric hospital admissions.
This trial showed a significant effect of a digital SDM tool on the subjective level of patient activation, confidence in communicating with one's provider, and feeling prepared for decision-making at the postintervention time point. The effect size was smaller than the 0.42 effect size that we had anticipated and sampled for. The trial contributes to the evidence on how digital tools may support patient-centered care and SDM in mental health care.
ClinicalTrials.gov NCT03554655; https://clinicaltrials.gov/ct2/show/NCT03554655.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-doi: 10.1186/s12888-019-2143-2.
共同决策（SDM）是一种旨在通过确保患者和提供者积极参与治疗决策来促进以患者为中心的护理的过程。在精神卫生保健中，SDM 被提倡为患者获得或重新获得对其生活和康复过程的控制和责任的一种手段。为了支持以患者为中心的护理和 SDM 过程，数字工具在可及性、结构和提醒方面可能具有优势。
在这项随机对照试验中，我们旨在研究支持患者激活和 SDM 的数字工具的效果。
该试验设计为随机、评估者盲、2 臂、平行组、多中心试验，比较使用数字 SDM 干预 6 个月与常规治疗。参与者为丹麦首都地区 9 个门诊治疗点的精神分裂症、精神分裂型或妄想障碍诊断患者。主要结局是干预后时间点的自我报告激活水平。次要结局包括自我效能感、希望、工作联盟、满意度、治疗咨询准备度、症状严重程度和功能水平。在干预的中期收集干预效果的探索性结局以及数字工具使用的客观数据。
共纳入 194 名参与者。意向治疗分析显示，干预组在患者激活（平均差异 4.39，95%CI 0.99-7.79；Cohen d=0.33；P=.01）、与提供者沟通的信心（平均差异 1.85，95%CI 0.01-3.69；Cohen d=0.24；P=.05）和决策准备感（平均差异 5.12，95%CI 0.16-10.08；Cohen d=0.27；P=.04）方面具有统计学显著效果。我们没有发现数字 SDM 工具对治疗满意度、希望、自我效能感、工作联盟、症状严重程度、功能水平、抗精神病药物使用以及精神科住院次数或住院时间长度有影响。
这项试验显示，数字 SDM 工具对患者激活、与提供者沟通的信心和决策准备感的主观水平在干预后时间点具有显著影响。效应大小小于我们预期和抽样的 0.42 效应大小。该试验为数字工具如何支持精神卫生保健中的以患者为中心的护理和 SDM 提供了证据。
ClinicalTrials.gov NCT03554655；https://clinicaltrials.gov/ct2/show/NCT03554655。
国际注册报告标识符（IRRID）：RR2-doi：10.1186/s12888-019-2143-2。
