Feasibility Trial for Postoperative Wound Surveillance Using Smartphones

Study duration: 3 years

Population Description:

Patients are typically older adults with multiple comorbid conditions and low health
literacy. Caregivers may have a similar profile or may be younger with some technological
experience (adult son or daughter).

Recruitment and Consent Screening for eligibility: On the outpatient side, study personnel
will identify eligible participants from the vascular surgery clinic schedule. On the
inpatient side, study personnel will identify eligible participants from the service
inpatients with the assistance of service NPs and residents. Eligible patients will be
approached by study personnel and the operating surgeon or service NP to discuss the project
and obtain consent.

Enrollment/baseline: Research personnel will introduce the study, obtain consent, and perform
the training to teach a patient or caregiver how to take a picture of a wound.

A written consent will be obtained after a thorough discussion of the study. All of this
information will be explained in a non-technical fashion. Time will be provided to answer
patient and caregiver questions or concerns about the study. Patients and caregivers will
also be warned about the risks of a breach in confidentiality, and what measures will be
taken to try and prevent this, and also what will be done in the instance it may happen.

Study Activities Subject identification and recruitment: Study personnel with clinical access
will identify eligible participants from the medical record.

Data elements to be collected from the medical record following consent: age, sex, type of
surgery, date of surgery, surgical complications, zip code (to determine rural/urban status
and 4G coverage), and comorbidities (particularly cognitive impairment and motor functioning
impairment).

Treatment/intervention period: Regardless of where patients have been recruited and
consented, the patient and/or their caregiver will be trained to use the app in the
post-operative, predischarge period; additional training will be provided on how to use the
device, as necessary. Notes will be taken to document the success of training and to identify
any potential areas for improvement in the training protocol. The study personnel will then
explain the protocol for when the patient is discharged home and answer any questions the
patient and/or their caregiver may have. Participants will be provided with an iPhone 5,
which will be theirs to keep following study completion. Prior to assigning a smartphone to a
participant, study personnel will be guided through a process to reset the device and erase
any information that was stored on it from the prior user. Participants' names and medical
record numbers are encrypted and stored only in the backend app and are never placed on the
device.

When the patient is discharged from the hospital, they will then be asked to take a
photograph of their surgical wound and answer a short survey about their wound and their
general recovery using the smartphone app. This information will be transmitted via encrypted
connection to a secure research server in the UW Department of Surgery. A composite screen
will be created that displays all of the transmitted images as well as the responses to the
survey questions within the app. Each afternoon, a service NP or study personnel with MD
surgical training will review the data transmitted and complete a short form documenting the
appearance of the surgical wound. Within the review screen, the reviewer can mark the data as
already reviewed, which will move the record to an archive list. This form will be scanned
into the patient's medical record if there is new evidence of a burgeoning complication; the
image will remain on the department server and not be associated with the medical record. Any
concerning findings will prompt a phone call from the surgical service nurse practitioner
(NP) to the patient to gather more information and recommend additional
intervention/treatment as indicated, which may include antibiotics or a clinic visit; upon
detection of a burgeoning complication, usual care clinical protocol takes over (as if the
patient had called with the concern). Additionally, contact information for the vascular
surgery clinic and study personnel is provided at 2 points through the app itself, so that
patients and their caregivers can easily call with questions or concerns.

If a patient has not submitted information in the past 24 hours, a study personnel will call
the patient to discuss the protocol and any difficulties they may be having with completing
it. The phone call will not be punitive, but will be aimed at decreasing study attrition,
identifying reasons why patients are not compliant with the stated protocol, and identifying
possible measures to improve the protocol. Three attempts will be made to contact an
individual patient. All patients will receive a call 5-6 days following discharge to assess
use of the app regardless of attrition status.

Specific Aims/Study Objectives:

Goal: Evaluate the effectiveness and feasibility of a protocol for post-discharge wound
monitoring using a smartphone app and its ability to detect postoperative wound complications
and reduce hospital readmissions in a vascular surgery patient population..

Hypotheses being tested:

H 1: With a well-designed app and training module, patients will be empowered by the
opportunity to participate in their postoperative care and prevent potentially life
threatening wound complications.

H 2: Through the use of this smartphone app in the post-discharge period, wound complications
will be detected earlier than they would be otherwise and that the need for hospital
readmissions will decrease.

Device Information App description: Screen shots uploaded as supplementary content. No
information or photo is retained on the phone. UW Department of Surgery IT, the entity who
developed the app, has ensured that the app is HIPAA-compliant. Neither photos generated in
this study nor associated information will be stored directly to the phone's camera role.

Device specifications, packaging, labeling: Smartphones will be iPhone 5s or 6 purchased
through collaboration with AT&T.

1. Device iOS devices running iOS 8 or higher. A pass code will be used to secure and encrypt
the device.

Devices will be maintained using the Apple Profile Manager which will allow remote-wiping of
devices, preventing the install of additional apps, and limiting of other device features.

The Wound App (mobile application) will be installed through the Apple Profile Manager. The
Wound app will not save any protected health information into permanent storage on the
device. Photos and responses will be held in application memory before being submitted back
to a Department of Surgery web server.

If the user is idle for more than 10 minutes the app will time out.

Photos and responses will be released from memory after they have been submitted or after the
app has timed out.

Inclusion Criteria:

- Vascular surgery patient capable of independently completing protocol or who has an
identifiable competent caregiver

- Incision >3 cm in length

Exclusion Criteria:

- No decisional capacity and absence of competent caregiver

- Identifying mark in area of the wound that would be capture in digital image of the
wound

- Under age 18 years