Wound And Symptom Tracking After Colorectal Surgery Using How2trak

NCT04869774 | Unknown

• 1 other identifier: 20200596-01H
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgical Site Infection; Mobile Applications; Surgery--Complications; Colorectal Surgery

Outcome Measures

Primary Outcomes (7)

• Capability for enrollment

  number of patients per month on average are enrolled in the study

  6 months

• Feasibility of the randomization processes

  proportion of patients randomized to the intervention or control group.

  6 months

• How2trak compliance

  Proportion of self-assessments completed by patients, on average.

  6 months

• How2trak usability, delivery and compliance

  The mean score for the patient and clinician survey of H2T application.

  6 months

• 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

• 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

• 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 Outcomes (4)

• Surgical Site Infection (SSI) Rate

  6 months

• Patient experience

  6 months

• Healthcare System Time

  6 months

• Covid-19 infection Rate

  6 months

Study Arms (2)

Virtual Monitoring

ACTIVE COMPARATOR

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

Standard of Care

NO INTERVENTION

Patients discharged from hospital after colorectal surgery will receive standard of care with no virtual monitoring of their surgical incision and symptoms.

Interventions

How2Trak mobile application DEVICE

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.

Virtual Monitoring

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ottawa: lead
• The Ottawa Hospital: collaborator
• Health Outcomes Worldwide: collaborator

Related Publications (1)

• 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.

  PMID: 34854816 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Reilly Musselman, MD, MSc

  University of Ottawa

  PRINCIPAL INVESTIGATOR

• Heather Smith, MD, MSc

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reilly Musselman, MD, MSc

CONTACT

613-798-5555; rmusselman@toh.ca

Heather Smith, MD,MSc

CONTACT

613-798-5555; hsmit037@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study will be unblinded so no attempts at concealment of individuals' allocation will be made.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 3, 2021
• Study Start: May 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share