Effectiveness of shared decision making strategies for stroke prevention among patients with atrial fibrillation: cluster randomized controlled trial.

Methods

Cluster randomized controlled trial.

群组随机对照试验。

Six academic medical centers in the United States.

研究在美国六家学术医疗中心进行。

Patient participants were aged ≥18 with a diagnosis of non-valvular atrial fibrillation, at risk for stroke (CHA2DS2-VASc ≥1 for men, ≥2 for women), and scheduled for a clinical appointment to discuss stroke prevention strategies.

患者参与者年龄≥18岁，被诊断为非瓣膜性房颤，有中风风险（CHA2DS2-VASc评分男性≥1分，女性≥2分），并计划进行临床预约以讨论中风预防策略。

Participating clinicians were those who manage stroke prevention strategies for participating patients.

参与的临床医生是那些为参与患者管理中风预防策略的医生。

intervention

Patients were randomized to use a patient decision aid or usual care; clinicians were randomized to use an encounter decision aid or usual care with all participating patients.

患者被随机分配使用患者决策辅助工具或常规护理；临床医生被随机分配使用接诊决策辅助工具或对所有参与患者使用常规护理。

Methods

Primary outcome measures were quality of shared decision making measured by OPTION12, knowledge of atrial fibrillation and its management, and decisional conflict.

主要结果指标是通过OPTION12测量的共享决策质量、对房颤及其管理的知识以及决策冲突。

Results

1117 participants across six sites were included in the analysis.

分析中包括了六个地点的1117名参与者。

Compared with usual care, the combined use of both the patient decision aid and the encounter decision aid improved the quality of shared decision making (adjusted mean difference 12.1 (95% confidence interval(CI) 8.0 to 16.2; P<0.001), improved patients' knowledge (odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001), and reduced patients' decisional conflict (adjusted mean difference -6.3 (95% CI -9.6 to -3.1; P<0.001).

与常规护理相比，患者决策辅助工具和面谈决策辅助工具的联合使用提高了共享决策的质量（调整后平均差异为12.1（95%置信区间（CI）8.0至16.2；P<0.001）），提高了患者的认知水平（优势比为1.68（95% CI 1.35至2.09；P<0.001）），并减少了患者的决策冲突（调整后平均差异为-6.3（95% CI -9.6至-3.1；P<0.001）。

Statistically significant improvements were also observed with the encounter decision aid alone versus usual care for all three outcomes and with the patient decision aid alone versus usual care for quality of shared decision making and knowledge.

与常规护理相比，仅使用面谈决策辅助工具在所有三个结果上也观察到了统计学上的显著改善，而仅使用患者决策辅助工具与常规护理相比，在共享决策质量和知识方面也观察到了显著改善。

No important differences were observed in treatment choices for stroke prevention or in participants' satisfaction.

在中风预防的治疗选择或参与者的满意度方面，未观察到重要差异。

No statistically significant difference in the length of visit across study groups was detected.

在研究组之间，未检测到访问时长存在统计学上的显著差异。

Conclusions

Patients who received any decision aid (encounter decision aid, patient decision aid, or both) had lower decisional conflict, better shared decision making, and greater knowledge than those receiving no decision aid, except for the effect of the patient decision aid on decisional conflict, which did not reach statistical significance.

接受任何决策辅助工具（包括会前决策辅助工具、患者决策辅助工具或两者）的患者，其决策冲突较低，共享决策更好，知识掌握程度更高，与未接受决策辅助工具的患者相比，除了患者决策辅助工具对决策冲突的影响未达到统计学显著性外。

The study establishes that use of either pre-visit or in-visit decision aids individually or in combination is advantageous compared with usual care.

该研究表明，无论是单独使用还是结合使用会前或会中决策辅助工具，都比常规护理更有优势。

trial_registration

ClinicalTrials.gov NCT04357288.

ClinicalTrials.gov 注册号 NCT04357288。