Wound And Symptom Tracking After Colorectal Surgery Using How2trak

Surgical Site Infection Clinical Trial

— WATCH  

Official title:

A Mobile Application for Wound and Symptom Surveillance After Colorectal Surgery: a Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04869774
• Other study ID #: 20200596-01H
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: February 2022

Study information

• Verified date: April 2021
• Source: University of Ottawa
• Contact: Reilly Musselman, MD, MSc
• Phone: 613-798-5555
• Email: rmusselman[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colorectal Surgery
• Mobile Applications
• Surgery--Complications
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• How2Trak mobile application
Patients will undergo virtual monitoring of their incision and symptoms using the How2Trak application(app). Using the app, patients will be asked to answer a series of questions and photograph their surgical incision on post-operative day 3, 5, 7, 10, 20, and 30. Patient responses and photographs entered into the app will be reviewed within 72 hours by a trained Nurse Specialized in Wound, Ostomy and Continence. If a concern is identified the nurse will contact the patient to arrange a virtual visit using the how2trak app or notify the surgeon team (including colorectal surgeons and physician residents) in accordance with clinical discretion.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Ottawa	Health Outcomes Worldwide, The Ottawa Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capability for enrollment	number of patients per month on average are enrolled in the study	6 months
Primary	Feasibility of the randomization processes	proportion of patients randomized to the intervention or control group.	6 months
Primary	How2trak compliance	Proportion of self-assessments completed by patients, on average.	6 months
Primary	How2trak usability, delivery and compliance	The mean score for the patient and clinician survey of H2T application.	6 months
Primary	Monitoring of protocol deviation and safety	The number and frequency of events when study activities diverge from the REB-approved protocol or are considered adverse events.	6 months
Primary	Feasibility of data extraction	Proportion of patients for which all primary outcomes of the definitive trial are recorded. This includes the SSI incidence and severity and patient experience.	6 months
Primary	Resources and time required to conduct the feasibility trial will be assessed	There is adequate administrative capacity, expertise, skills, space and time of the research team to complete the study.	8 months
Secondary	Surgical Site Infection (SSI) Rate	Secondary outcomes will include SSI incidence and severity.	6 months
Secondary	Patient experience	Response to patient experience survey	6 months
Secondary	Healthcare System Time	Hours of in-person interactions with the healthcare system, including readmissions to hospital, ED visits, clinic visits etc.	6 months
Secondary	Covid-19 infection Rate	Confirmed COVID-19 infection within 30 days after surgery.	6 months