A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery
A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial
研究概览
详细说明
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.
Significance: This study will contribute evidence regarding the use of mobile device technology for education and the direct involvement of patients as stakeholders in postoperative recovery.
The study findings have the potential to increase patient engagement in the care pathway, which has the potential to increase compliance to pathway elements and improve postoperative outcomes.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Quebec
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Montréal、Quebec、加拿大、h3g1a4
- Montreal General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- elective laparoscopic colorectal resection.
- Proficient in english or french
Exclusion Criteria:
- intellectual disabilities
- major simultaneous procedures
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
假比较器:control
Patients receive an ipad with no app.
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Patient receive an ipad with no application.
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实验性的:Mobile application no stoma
Patients who did not receive a stoma receive an ipad containing the app and are instructed how to use it.
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A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway.
Contains information, guidelines, questionnaires and feedback
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实验性的:Mobile application stoma
Patients who receive a stoma receive an ipad containing the app and are instructed how to use it.
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A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway.
Contains information, guidelines, questionnaires and feedback
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.
大体时间:postoperative day 2
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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).
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postoperative day 2
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Length of stay
大体时间:one month
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Number of days spent in the hospital after surgery
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one month
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Complications
大体时间:one month
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Comprehensive complication index (CCI)
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one month
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Successful Recovery
大体时间:postoperative day 4
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Discharge by postoperative day 4 with no complications.
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postoperative day 4
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Control.的临床试验
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Devicare S.L.Clever Instruments S.L.; Fundacio Puigvert未知
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Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)招聘中
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Gonzalez-Heydrich, Joseph, M.D.Boston Children's Hospital; Harvard University完全的
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University of Puerto RicoNational Institutes of Health (NIH)招聘中
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Ananda Basu, MDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); DexCom, Inc.; Tandem...完全的
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United States Department of DefenseVirginia Commonwealth University; James J. Peters Veterans Affairs Medical Center; Hunter Holmes...完全的