The Impact of Non-Pharmacological Interventions on Patient Experience, Opioid Use, and Healthcare Utilization in Adult Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of days in the hospital after surgery
研究概览
简要总结
This study will assess whether non-pharmacological interventions by a comfort coach affect the amount of opioid pain medication used, as well as perceived physical pain and emotional anxiety and healthcare utilization for adult cardiac surgery patients. Participants that are eligible for the study will be randomized to the comfort coach arm or standard of care. Both groups will complete surveys at the specific time frames in order to compare their outcomes. The study hypothesis is that there will be a decrease in opioid use in the intervention group compared to the standard of care arm during the 90-day perioperative course, as well as a decrease in pain and anxiety along with a lower composite outcome of healthcare utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Research assistants consenting patients and collecting and analyzing data will be blinded to the allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving a first-time elective status open heart cardiac surgery procedure in the Frankel Cardiovascular Center at Michigan Medicine during the recruitment period through a full or miniature sternotomy incision
- •Opioid-naïve, defined as not taking a home opioid medication at time of preoperative H&P
排除标准
- •Patients undergoing cardiac transplantation, implantation of ventricular assist device, reoperation, and any planned use of circulatory arrest
- •Chronic opioid users defined as taking an opioid at time of preoperative clinic visit
- •Non-English speaking
- •Inability to understand or complete surveys
- •Pregnancy
- •Unable to sign legal consent form (legal guardian signature not acceptable)
结局指标
主要结局
Number of days in the hospital after surgery
时间窗: average 5-7 days
Number of days admitted to an extended care facility after discharge from the hospital
时间窗: up to 30 days after surgery
Number of days spent at home within the first 30 days after surgery
时间窗: up to 30 days after surgery
Number of days spent at home compared between groups
Number and length of readmissions to the hospital following initial discharge after surgery
时间窗: up to 30 days after surgery
Number of emergency room visits after discharge from the hospital
时间窗: up to 30 days after surgery
次要结局
- Postoperative Opioid and Pain Management Questionnaire(approximately 30 days after discharge)
- Picker Patient Experience Questionnaire (PPE-15)(approximately 30 days after discharge)
- Impact of Events Scale-Revised (IES-R)(approximately 30 days after discharge)
- Brief pain inventory (short)(hospital discharge (within 48 hours of time of hospital discharge))
- Generalized Anxiety Disorder Scale (GAD-7)(up to approximately 90 days after discharge)
- Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)(preoperative clinic visit, approximately 30 days after discharge)
- Patient Health Questionnaire (PHQ-9)(up to approximately 90 days after discharge)
研究者
Julie Piazza
Project Manager
University of Michigan