A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.
研究概览
简要总结
A randomized control trial on patients undergoing laparoscopic colorectal resection in an Enhanced Recovery Program (ERP). The intervention is delivered via an electronic application containing guidelines, information, and tailored feedback. The hypothesis is that the application will improve adherence to the ERP.
详细描述
Introduction: Enhanced Recovery Programs (ERP) in colorectal surgery reduce postoperative morbidity and shorten length of hospital stay with no increase in readmission rates. However, poor adherence to ERP elements remains a challenge. Recent studies suggest that the use of mobile device applications has the potential to improve patient compliance with treatment guidelines. We recently developed and pilot tested a mobile app to support an ERP for colorectal surgery which collects patient-reported recovery information and engages patients as stakeholders in their recovery process. The overall aim of this study is to estimate the extent to which the use of this mobile device app impacts adherence to postoperative ERP elements in comparison to standard preoperative education.
Methods. The proposal is for a two-group, assessor-blind, randomized trial including adult patients with colorectal diseases planned for surgical resection.
Participants will be randomly assigned into one of two groups:
- usual perioperative education and audit, or
- a mobile device application for postoperative education and self-audit.
The intervention will be delivered through a tablet present at the bedside with an application which links education, recovery planning, and daily self-assessment to a plan of care. It educates patients about daily recovery milestones and track their adherence. The primary outcome will be patient adherence to postoperative enhanced recovery elements. Other targeted outcomes include self-reported recovery, satisfaction and patient activation. According to an a priori power analysis, a sample of 104 patients (52 per group) is targeted for this trial.
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
- Double (Care Provider, Outcomes Assessor)
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
- •elective laparoscopic colorectal resection.
- •Proficient in english or french
排除标准
- •intellectual disabilities
- •major simultaneous procedures
研究组 & 干预措施
control
Patients receive an ipad with no app.
干预措施: Control. (Other)
Mobile application no stoma
Patients who did not receive a stoma receive an ipad containing the app and are instructed how to use it.
干预措施: Mobile application (Device)
Mobile application stoma
Patients who receive a stoma receive an ipad containing the app and are instructed how to use it.
干预措施: Mobile application (Device)
结局指标
主要结局
Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.
时间窗: postoperative day 2
Questionnaire including 5 pathway interventions that involve patient participation during the first 48 hours after surgery (mobilization, gum chewing, consumption of oral liquids, breathing exercises, nutritional supplement).
次要结局
- Complications(one month)
- Length of stay(one month)
- Successful Recovery(postoperative day 4)
研究者
Dr. Liane S. Feldman
Professor, Department of Surgery, McGill University Director, General Surgery Clinical Teaching Unit, Montreal General Hospital. Director, Division of General Surgery at the MUHC and McGill University. Program Director, MIS Fellowship Program.
McGill University Health Centre/Research Institute of the McGill University Health Centre