Surgical Site InfectionWATCHNCT04869774
Wound And Symptom Tracking After Colorectal Surgery Using How2trak
A study testing How2Trak mobile application in people with Surgical Site Infection and Mobile Applications, run by University of Ottawa.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Mobile Applications, Surgery--Complications
- What is being tested?
- How2Trak mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Mobile Application for Wound and Symptom Surveillance After Colorectal Surgery: a Feasibility Randomized Controlled Trial
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.
Read the 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.
- Being tested
- How2Trak mobile application
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
How2Trak mobile applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capability for enrollment
number of patients per month on average are enrolled in the study
Measured: 6 months
Feasibility of the randomization processes
proportion of patients randomized to the intervention or control group.
Measured: 6 months
How2trak compliance
Proportion of self-assessments completed by patients, on average.
Measured: 6 months
How2trak usability, delivery and compliance
The mean score for the patient and clinician survey of H2T application.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months
Secondary outcomes (4)
Surgical Site Infection (SSI) Rate
Secondary outcomes will include SSI incidence and severity.
Measured: 6 months
Patient experience
Response to patient experience survey
Measured: 6 months
Healthcare System Time
Hours of in-person interactions with the healthcare system, including readmissions to hospital, ED visits, clinic visits etc.
Measured: 6 months
Covid-19 infection Rate
Confirmed COVID-19 infection within 30 days after surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study startMay 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital, Health Outcomes Worldwide
- Responsible party
- Principal investigator, Reilly Patrick Musselman, University of Ottawa
- Investigators
- Reilly Musselman, MD, MSc, Principal investigator, University of OttawaHeather Smith, MD, MSc, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869774
- Sponsor's protocol ID
- 20200596-01H
- Acronym
- WATCH
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 34854816
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Application for Wound and Symptom Surveillance After Colorectal Surgery: a Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04869774
- Acronym / sponsor ID
- WATCH / 20200596-01H
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- The Ottawa Hospital, Health Outcomes Worldwide
- Study start
- May 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Monitoring | Active comparator | Device: How2Trak mobile applicationPatients discharged from hospital after colorectal surgery will have virtual monitoring of their surgical incision and symptoms, using the mobile application How2Trak, post-operatively. |
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| How2Trak mobile applicationPatients 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. | Device | Virtual Monitoring |
Primary outcome
Capability for enrollment
Time frame: 6 months
number of patients per month on average are enrolled in the study
Feasibility of the randomization processes
Time frame: 6 months
proportion of patients randomized to the intervention or control group.
How2trak compliance
Time frame: 6 months
Proportion of self-assessments completed by patients, on average.
How2trak usability, delivery and compliance
Time frame: 6 months
The mean score for the patient and clinician survey of H2T application.
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.
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.
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.
4 secondary outcomes
Surgical Site Infection (SSI) Rate
Time frame: 6 months
Patient experience
Time frame: 6 months
Healthcare System Time
Time frame: 6 months
Covid-19 infection Rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Derived from this study: PubMed 34854816Valk 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reilly Musselman, MD, MSc principal investigator
University of Ottawa
Heather Smith, MD, MSc principal investigator
University of Ottawa
Questions about this trial
What is this clinical trial studying?
A study testing How2Trak mobile application in people with Surgical Site Infection and Mobile Applications, run by University of Ottawa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reilly Musselman, MD, MSc (613-798-5555, rmusselman@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capability for enrollment (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04869774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.