Wound And Symptom Tracking After Colorectal Surgery Using How2trak (WATCH)

• ClinicalTrials.gov Identifier: NCT04869774
• Recruitment Status: Not yet recruiting
• First Posted: May 3, 2021
• Last Update Posted: May 3, 2021
• Sponsor: University of Ottawa
• Collaborators: The Ottawa Hospital; Health Outcomes Worldwide
• Information provided by (Responsible Party): Reilly Patrick Musselman, University of Ottawa

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Surgical Site Infection; Mobile Applications; Surgery--Complications; Colorectal Surgery	Device: How2Trak mobile application	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: This study will be unblinded so no attempts at concealment of individuals' allocation will be made.
• Primary Purpose: Diagnostic
• Official Title: A Mobile Application for Wound and Symptom Surveillance After Colorectal Surgery: a Feasibility Randomized Controlled Trial
• Estimated Study Start Date: May 2021
• Estimated Primary Completion Date: November 2021
• Estimated Study Completion Date: February 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Virtual Monitoring; Patients discharged from hospital after colorectal surgery will have virtual monitoring of their surgical incision and symptoms, using the mobile application How2Trak, post-operatively.	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.
No Intervention: Standard of Care; Patients discharged from hospital after colorectal surgery will receive standard of care with no virtual monitoring of their surgical incision and symptoms.

Outcome Measures

Primary Outcome Measures :

1. Capability for enrollment [ Time Frame: 6 months ]
   number of patients per month on average are enrolled in the study
2. Feasibility of the randomization processes [ Time Frame: 6 months ]
   proportion of patients randomized to the intervention or control group.
3. How2trak compliance [ Time Frame: 6 months ]
   Proportion of self-assessments completed by patients, on average.
4. How2trak usability, delivery and compliance [ Time Frame: 6 months ]
   The mean score for the patient and clinician survey of H2T application.
5. Monitoring of protocol deviation and safety [ Time Frame: 6 months ]
   The number and frequency of events when study activities diverge from the REB-approved protocol or are considered adverse events.
6. Feasibility of data extraction [ Time Frame: 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.
7. Resources and time required to conduct the feasibility trial will be assessed [ Time Frame: 8 months ]
   There is adequate administrative capacity, expertise, skills, space and time of the research team to complete the study.

Secondary Outcome Measures :

1. Surgical Site Infection (SSI) Rate [ Time Frame: 6 months ]
   Secondary outcomes will include SSI incidence and severity.
2. Patient experience [ Time Frame: 6 months ]
   Response to patient experience survey
3. Healthcare System Time [ Time Frame: 6 months ]
   Hours of in-person interactions with the healthcare system, including readmissions to hospital, ED visits, clinic visits etc.
4. Covid-19 infection Rate [ Time Frame: 6 months ]
   Confirmed COVID-19 infection within 30 days after surgery.

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Reilly Musselman, MD, MSc; 613-798-5555; rmusselman@toh.ca

Contact: Heather Smith, MD,MSc; 613-798-5555; hsmit037@uottawa.ca

Sponsors and Collaborators

University of Ottawa

The Ottawa Hospital

Health Outcomes Worldwide

Investigators

• Principal Investigator: Reilly Musselman, MD, MSc; University of Ottawa
• Principal Investigator: Heather Smith, MD, MSc; University of Ottawa

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Reilly Patrick Musselman, Principal Investigator, University of Ottawa
• ClinicalTrials.gov Identifier: NCT04869774
• Other Study ID Numbers: 20200596-01H
• First Posted: May 3, 2021
• Last Update Posted: May 3, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Plan Description

There are no plans to share IPD with other partners, collaborators, or researchers.

Data will be captured through the assessments and/or photographs in the app and EPIC. Data sent from how2trak to TOH will be transferred through a secure, access-controlled folder within Office 365 including patient identifiers to allow for merging with EPIC data. Once the data files are merged, they will be deidentified. Only research personnel will have access to the study data. A data monitoring committee will not be developed given the minimal risk and small sample size of this feasibility trial.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Surgical Wound Infection; Wound Infection; Infections; Postoperative Complications; Pathologic Processes