Clinical trial NCT04869774: Wound And Symptom Tracking After Colorectal Surgery Using How2trak
Official title: A Mobile Application for Wound and Symptom Surveillance After Colorectal Surgery: a Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Site Infection
Mobile Applications
Surgery--Complications
Colorectal Surgery
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
name: Health Outcomes Worldwide
First posted: 2021-05-03
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Capability for enrollment
timeFrame: 6 months
measure: Feasibility of the randomization processes
timeFrame: 6 months
measure: How2trak compliance
timeFrame: 6 months
measure: How2trak usability, delivery and compliance
timeFrame: 6 months
measure: Monitoring of protocol deviation and safety
timeFrame: 6 months
measure: Feasibility of data extraction
timeFrame: 6 months
measure: Resources and time required to conduct the feasibility trial will be assessed
timeFrame: 8 months
Secondary outcomes:
measure: Surgical Site Infection (SSI) Rate
timeFrame: 6 months
measure: Patient experience
timeFrame: 6 months
measure: Healthcare System Time
timeFrame: 6 months
measure: Covid-19 infection Rate
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Ottawa
name: Reilly Musselman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Heather Smith, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valk HA, Garcia-Ochoa C, Fontaine Calder J, Miller T, Rashidi B, McIsaac C, Musselman R. A Mobile App for Wound and Symptom Surveillance After Colorectal Surgery: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2022 Jan 14;11(1):e26717. doi: 10.2196/26717.