Brescia Alexander A, Piazza Julie R, Jenkins Jessica N, Heering Lindsay K, Ivacko Alexander J, Piazza James C, Dwyer-White Molly C, Peters Stefanie L, Cepero Jesus, Brown Bailey H, Longi Faraz N, Monaghan Katelyn P, Bauer Frederick W, Kathawate Varun G, Jafri Sara M, Webster Melissa C, Kasperek Amanda M, Garvey Nickole L, Schwenzer Claudia, Wu Xiaoting, Lagisetty Kiran H, Osborne Nicholas H, Waljee Jennifer F, Riba Michelle, Likosky Donald S, Byrnes Mary E, Deeb G Michael
Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.
Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United States.
JMIR Res Protoc. 2021 Feb 16;10(2):e21350. doi: 10.2196/21350.
Despite pharmacological treatments, patients undergoing cardiac surgery experience severe anxiety and pain, which adversely affect outcomes. Previous work examining pediatric and nonsurgical adult patients has documented the effectiveness of inexpensive, nonpharmacological techniques to reduce anxiety and pain as well as health care costs and length of hospitalization. However, the impact of nonpharmacological interventions administered by a dedicated comfort coach has not been evaluated in an adult surgical setting.
This trial aims to assess whether nonpharmacological interventions administered by a trained comfort coach affect patient experience, opioid use, and health care utilization compared with usual care in adult cardiac surgery patients. This study has 3 specific aims: assess the effect of a comfort coach on patient experience, measure differences in inpatient and outpatient opioid use and postoperative health care utilization, and qualitatively evaluate the comfort coach intervention.
To address these aims, we will perform a prospective, randomized controlled trial of 154 adult cardiac surgery patients at Michigan Medicine. Opioid-naive patients undergoing first-time, elective cardiac surgery via sternotomy will be randomized to undergo targeted interventions from a comfort coach (intervention) versus usual care (control). The individualized comfort coach interventions will be administered at 6 points: preoperative outpatient clinic, preoperative care unit on the day of surgery, extubation, chest tube removal, hospital discharge, and 30-day clinic follow-up. To address aim 1, we will examine the effect of a comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction through validated surveys administered at preoperative outpatient clinic, discharge, 30-day follow-up, and 90-day follow-up. For aim 2, we will record inpatient opioid use and collect postdischarge opioid use and pain-related outcomes through an 11-item questionnaire administered at the 30-day follow-up. Hospital length of stay, readmission, number of days in an extended care facility, emergency room, urgent care, and an unplanned doctor's office visit will be recorded as the primary composite endpoint defined as total days spent at home within the first 30 days after surgery. For aim 3, we will perform semistructured interviews with patients in the intervention arm to understand the comfort coach intervention through a thematic analysis.
This trial, funded by Blue Cross Blue Shield of Michigan Foundation in 2019, is presently enrolling patients with anticipated manuscript submissions from our primary aims targeted for the end of 2020.
Data generated from this mixed methods study will highlight effective nonpharmacological techniques and support a multidisciplinary approach to perioperative care during the adult cardiac surgery patient experience. This study's findings may serve as the foundation for a subsequent multicenter trial and broader dissemination of these techniques to other types of surgery.
ClinicalTrials.gov NCT04051021; https://clinicaltrials.gov/ct2/show/NCT04051021.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21350.
尽管有药物治疗，但接受心脏手术的患者仍会经历严重的焦虑和疼痛，这对手术结果产生不利影响。先前针对儿科和非手术成年患者的研究已证明，廉价的非药物技术在减轻焦虑和疼痛、降低医疗成本以及缩短住院时间方面具有有效性。然而，由专业舒适护理师实施的非药物干预措施在成年手术患者中的效果尚未得到评估。
本试验旨在评估与常规护理相比，由经过培训的舒适护理师实施的非药物干预措施对成年心脏手术患者的体验、阿片类药物使用及医疗资源利用情况的影响。本研究有3个具体目标：评估舒适护理师对患者体验的影响；测量住院和门诊阿片类药物使用及术后医疗资源利用的差异；定性评估舒适护理师干预措施。
为实现这些目标，我们将在密歇根大学医学中心对154例成年心脏手术患者进行一项前瞻性随机对照试验。首次接受择期开胸心脏手术且未使用过阿片类药物的患者将被随机分为两组，一组接受来自舒适护理师的针对性干预（干预组），另一组接受常规护理（对照组）。个性化的舒适护理师干预将在6个时间点进行：术前门诊、手术当天的术前护理单元、拔管时、拔除胸管时、出院时以及术后30天门诊随访。为实现目标1，我们将通过在术前门诊、出院时、30天随访和90天随访时进行的有效调查问卷，研究舒适护理师对围手术期焦虑、自我报告的疼痛、功能状态和患者满意度的影响。对于目标2，我们将记录住院期间阿片类药物的使用情况，并通过在30天随访时发放的11项问卷收集出院后阿片类药物使用及疼痛相关结果。住院时间、再入院情况、在延长护理机构、急诊室、紧急护理机构的天数以及非计划的医生办公室就诊次数将被记录为主要综合终点，定义为术后前30天在家中的总天数。对于目标3，我们将对干预组患者进行半结构式访谈，通过主题分析了解舒适护理师干预措施。
这项由密歇根蓝十字蓝盾基金会于2019年资助的试验目前正在招募患者，预计2020年底提交主要目标的手稿。
这项混合方法研究产生的数据将突出有效的非药物技术，并支持在成年心脏手术患者体验期间采用多学科围手术期护理方法。本研究的结果可能为后续的多中心试验奠定基础，并将这些技术更广泛地推广到其他类型的手术中。
ClinicalTrials.gov NCT04051021；https://clinicaltrials.gov/ct2/show/NCT04051021。
国际注册报告识别码（IRRID）：DERR1-10.2196/21350。
