An interventional study of How2Trak mobile application in Surgical Site Infection, Mobile Applications and Surgery--Complications, sponsored by University of Ottawa. Status unknown. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-03.
Sponsored by University of Ottawa · Not applicable, Interventional, and Diagnostic
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.
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.
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's planned enrollment of 80 is below the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →University of Ottawa is the lead sponsor of 123 studies on the registry; 33 are open to participants now.
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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:
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 discharged from hospital after colorectal surgery will receive standard of care with no virtual monitoring of their surgical incision and symptoms.
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.
Capability for enrollment
number of patients per month on average are enrolled in the study
Time frame: 6 months
Feasibility of the randomization processes
proportion of patients randomized to the intervention or control group.
Time frame: 6 months
How2trak compliance
Proportion of self-assessments completed by patients, on average.
Time frame: 6 months
How2trak usability, delivery and compliance
The mean score for the patient and clinician survey of H2T application.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 months
Surgical Site Infection (SSI) Rate
Secondary outcomes will include SSI incidence and severity.
Time frame: 6 months
Patient experience
Response to patient experience survey
Time frame: 6 months
Healthcare System Time
Hours of in-person interactions with the healthcare system, including readmissions to hospital, ED visits, clinic visits etc.
Time frame: 6 months
Covid-19 infection Rate
Confirmed COVID-19 infection within 30 days after surgery.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No — 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.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of Ottawa