A Mobile Application for Wound and Symptom Surveillance After Colorectal Surgery: a Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Resources and time required to conduct the feasibility trial will be assessed
研究概览
简要总结
The purpose of this study is to assess the feasibility of using a mobile application (app) called how2trak to improve people's experience, wound surveillance, and detection of surgical site infections (SSI) after colorectal surgery while reducing in-person interactions for patients during the COVID-19 pandemic.
This will inform the implementation of a full-scale trial to establish if surveillance of someone's incision and symptoms using how2trak improves SSI detection and management compared to standard care (involving a single post-operative surgery clinic visit).
The data collected will contribute to a broader dataset of people with SSI surveillance to be used in developing a clinical decision support system.
详细描述
Background: Surgical site infections (SSI) are the most common nosocomial infection and occur in 16.3% of individuals undergoing colorectal surgery at our institution, the majority of which are identified after discharge from hospital. Patients concerned to have an SSI, generally present to the emergency department or surgery clinic. Both options for in-person interaction are costly to the healthcare system and patients, and increase their risk of COVID-19 exposure. A mobile application How2trak has proven to be beneficial for patients with complex wounds at our institution by facilitating at-home monitoring and virtual consultations.
Aim: This study aims to assess the feasibility of a randomized controlled trial to assess if How2trak can improve patients' experience, and detection of surgical site infections after colorectal surgery while reducing their risk of COVID-19 exposure.
Methods: In this single-center, prospective feasibility trial, eligible patients undergoing elective and semi-urgent colorectal surgery will be randomized to either standard care or How2trak post-operative monitoring of their incision, symptoms, and ostomy function. Patient self-assessments will be monitored by a nurse specialized in wound and ostomy care who will meet virtually with the patient as needed. The primary outcome is feasibility as measured by enrollment, randomization, H2T usability, data extraction, and resource capacity.
Results: We anticipate this work will help us to better understand the feasibility of using mobile technology to optimize patients' care after discharge from hospital after colorectal surgery. Virtual post-surgery wound and symptom monitoring could enhance patient experience, SSI detection, and reduce the risk of COVID-19 transmission. If this technology is feasible for our patient population and workflow, next steps will be to assess its effectiveness with a full-scale randomized controlled trial and explore additional applications including ostomy monitoring, patient education, and application in other surgical departments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
This study will be unblinded so no attempts at concealment of individuals' allocation will be made.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be 16 years of age or older who are being discharged from hospital after undergoing semi-urgent, urgent, or elective abdominal surgery by a colorectal surgeon at The Ottawa Hospital, and have provided informed consent to participate.
- •Patients enrolled in other clinical trials will still be candidates for this feasibility trial.
- •Clinicians using the how2trak app in this study will be considered study participants as well. They will be asked to complete the "Patient and Clinician Survey of Application". This survey addresses the experience with the use of the H2T app their feedback regarding usability is fundamental for future improvement.
排除标准
- •Individuals will be excluded if less than 16 years of age; have no access or ability to use a mobile device; no cellular data/WiFi access; and/or cannot read and write in English.
结局指标
主要结局
Resources and time required to conduct the feasibility trial will be assessed
时间窗: 8 months
There is adequate administrative capacity, expertise, skills, space and time of the research team to complete the study.
Capability for enrollment
时间窗: 6 months
number of patients per month on average are enrolled in the study
Feasibility of data extraction
时间窗: 6 months
Proportion of patients for which all primary outcomes of the definitive trial are recorded. This includes the SSI incidence and severity and patient experience.
Feasibility of the randomization processes
时间窗: 6 months
proportion of patients randomized to the intervention or control group.
How2trak compliance
时间窗: 6 months
Proportion of self-assessments completed by patients, on average.
How2trak usability, delivery and compliance
时间窗: 6 months
The mean score for the patient and clinician survey of H2T application.
Monitoring of protocol deviation and safety
时间窗: 6 months
The number and frequency of events when study activities diverge from the REB-approved protocol or are considered adverse events.
次要结局
- Patient experience(6 months)
- Surgical Site Infection (SSI) Rate(6 months)
- Healthcare System Time(6 months)
- Covid-19 infection Rate(6 months)
研究者
Reilly Patrick Musselman
Principal Investigator
University of Ottawa