评估心房颤动患者和遭遇决策辅助干预：RED-AF研究的基线特征-一项随机对照试验。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-01-01 DOI:10.1016/j.cct.2024.107773

Tanvi Nayak BA , Joshua T. Christensen PhD , Tyler Bardsley MS , Geoffrey D. Barnes MD, MSc , Kenzie A. Cameron PhD, MPH , Rod Passman MD, MSCE , Preeti Kansal MD , Daniel M. Witt PharmD, FCCP, BCPS , Kerri L. Cavanaugh MD, MHS , Angela Fagerlin PhD , Elissa M. Ozanne PhD , the STEP-UP AF Writing Group

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引用次数: 0

摘要

背景：房颤决策支持干预的随机评价（RED-AF）试验是一项多地点、随机对照临床试验，研究患者决策辅助和遭遇决策辅助在房颤（AF）患者临床遭遇期间促进共同决策（SDM）的有效性。我们试图描述试验中患者和临床医生的基线特征，并将其与更大房颤人群的人口统计数据进行比较。我们还对基线、6个月和12个月的流失率可能的预测因素进行了分析。方法：本研究是一项多中心随机对照试验，在美国六个学术中心进行，符合抗凝治疗条件的非瓣膜性房颤患者符合入组条件。在他们的基线临床接触后，通过问卷评估患者的人口统计学和特征。参与的临床医生完成了人口统计调查，报告了教育背景、专业和工作年限。通过单变量逻辑回归分析患者特征，以确定每个时间点失访患者的潜在趋势。RED-AF试验共纳入1117例患者，平均年龄69岁（SD 9.3）。患者主要是男性（61.7 %）和白人（89.1 %），33.7% %报告研究生或专业教育。临床医生（N = 107）来自心脏病学（68.2% %）、内科（13.1 %）和药学（14.0 %）等专业。在基线、6或12 个月的调查完成情况下，没有发现任何测量到的患者特征之间的显著关联。结论：RED-AF试验的基线人口统计数据反映了患者参与者与先前调查AF患者共同决策的研究在很大程度上相似。患者人口统计数据与流失率之间缺乏关联可能突出了整个研究调查完成的测试亚组之间的公平性。

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Evaluation of patient and encounter decision aid interventions for atrial fibrillation: Baseline characteristics of the RED-AF study - A Randomized Controlled Trial

Background

The Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation (RED-AF) trial is a multi-site, randomized controlled clinical trial examining the effectiveness of a patient decision aid and an encounter decision aid in promoting shared decision-making (SDM) during a clinical encounter for patients with atrial fibrillation (AF). We sought to describe baseline characteristics of patients and clinicians in the trial and compare them to the demographics of the larger AF population. We also conducted an analysis of possible predictors of attrition rates at baseline, 6 and 12 months.

Methods

This study was a multi-center randomized controlled trial conducted at six academic centers across the U.S. Patients with non-valvular AF who qualify for anticoagulation therapy were eligible for enrollment. Patient demographics and characteristics were evaluated via questionnaires after their baseline clinical encounter. Participating clinicians completed demographic surveys, reporting educational background, specialty, and years of experience. Patient characteristics were analyzed via univariate logistic regression to identify potential trends among those lost to follow-up at each timepoint.

Findings

A total of 1117 patients were enrolled in the RED-AF trial, with an average age of 69 (SD 9.3). Patients were predominantly male (61.7 %) and white (89.1 %), with 33.7 % reporting graduate or professional education. Clinicians (N = 107) were enrolled from specialties including cardiology (68.2 %), internal medicine (13.1 %), and pharmacy (14.0 %). No significant associations were found between any measured patient characteristics with survey completion at baseline, 6 or 12 months.

Conclusion

The baseline demographics of the RED-AF trial reflect that patient participants were largely similar to prior studies investigating shared-decision making in patients with AF. The lack of association between patient demographics and attrition rates may highlight equity across the tested subgroups for survey completion for the study as a whole.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.