Center for Patient-centered Heart and Lung Research, Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Building 63, Ullevål, PO Box 4956, Nydalen, 0424, Oslo, Norway.
Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
BMC Health Serv Res. 2020 Mar 27;20(1):256. doi: 10.1186/s12913-020-05125-5.
The Aortic Valve Replacement Readmission (AVRre) randomized control trial tested whether a telephone intervention would reduce hospital readmissions following surgical aortic valve replacement (SAVR). The telephone support provided 30 days of continuous phone-support (hotline) and two scheduled phone-calls from the hospital after discharge. The intervention had no effect on reducing 30-day all-cause readmission rate (30-DACR) but did reduce participants' anxiety compared to a control group receiving usual care. Depression and participant-reported health state were unaffected by the intervention. To better understand these outcomes, we conducted a process evaluation of the AVRre trial to gain insight into the (1) the dose and fidelity of the intervention, (2) mechanism of impacts, and (3) contextual factors that may have influenced the outcomes.
The process evaluation was informed by the Medical Research Council framework, a widely used set of guidelines for evaluating complex interventions. A mix of quantitative (questionnaire and journal records) and qualitative data (field notes, memos, registration forms, questionnaire) was prospectively collected, and retrospective interviews were conducted. We performed descriptive analyses of the quantitative data. Content analyses, assisted by NVivo, were performed to evaluate qualitative data.
The nurses who were serving the 24/7 hotline intervention desired to receive more preparation before intervention implementation. SAVR patient participants were highly satisfied with the telephone intervention (58%), felt safe (86%), and trusted having the option of calling in for support (91%). The support for the telephone hotline staff was perceived as a facilitator of the intervention implementation. Content analyses revealed themes: "gap in the care continuum," "need for individualized care," and "need for easy access to health information" after SAVR. Differences in local hospital discharge management practices influenced the 30-DACR incidence.
The prospective follow-up of the hotline service during the trial facilitated implementation of the intervention, contributing to high participant satisfaction and likely reduced their anxiety after SAVR. Perceived less-than-optimal preparations for the hotline could be a barrier to AVRre trial implementation. Integrating user experiences into a mixed-methods evaluation of clinical trials is important for broadening understanding of trial outcomes, the mechanism of impact, and contextual factors that influence clinical trials.
ClinicalTrials.gov, NCT02522663. Registered on 11 August 2015.
主动脉瓣置换再入院（AVRre）随机对照试验测试了电话干预是否会降低心脏外科主动脉瓣置换（SAVR）后的医院再入院率。该电话支持提供了 30 天的连续电话支持（热线）和出院后两次来自医院的预定电话。与接受常规护理的对照组相比，该干预措施并未降低 30 天全因再入院率（30-DACR），但确实降低了参与者的焦虑感。干预措施对抑郁和参与者报告的健康状况没有影响。为了更好地了解这些结果，我们对 AVRre 试验进行了过程评估，以深入了解（1）干预的剂量和保真度，（2）影响机制，以及（3）可能影响结果的背景因素。
过程评估以医学研究委员会框架为依据，该框架是评估复杂干预措施的广泛使用指南。前瞻性收集了定量（问卷和日记记录）和定性数据（现场笔记、备忘录、登记表、问卷），并进行了回顾性访谈。我们对定量数据进行了描述性分析。内容分析，在 NVivo 的协助下，对定性数据进行了评估。
负责 24/7 热线干预的护士希望在干预实施前接受更多准备。SAVR 患者参与者对电话干预非常满意（58%），感到安全（86%），并相信有打电话寻求支持的选择（91%）。对电话热线工作人员的支持被认为是干预实施的促进因素。内容分析揭示了 SAVR 后的主题：“护理连续体中的差距”、“个性化护理的需求”和“获取健康信息的便捷需求”。当地医院出院管理实践的差异影响了 30-DACR 的发生率。
试验期间热线服务的前瞻性随访促进了干预的实施，使参与者在 SAVR 后满意度提高，并可能降低他们的焦虑感。热线准备不足被认为是 AVRre 试验实施的障碍。将用户体验纳入临床试验的混合方法评估对于扩大对试验结果、影响机制和影响临床试验的背景因素的理解非常重要。
ClinicalTrials.gov，NCT02522663。于 2015 年 8 月 11 日注册。
