Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02735525
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2016-04-01
Brief Title:
Feasibility Trial for Postoperative Wound Surveillance Using Smartphones
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Feasibility Trial for Postoperative Wound Surveillance Using Smartphones
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed trial is a pilot to test a smartphone application app that will ultimately allow patients to take and transmit photos of their postoperative wounds from home and relay other symptom information This protocol covers the single-institution pilot study of the apps use in the period between hospital discharge and a patients first follow-up clinic visit The investigators will recruit vascular surgery patients either preoperatively in clinic or in the post-operative pre-discharge period following surgery to participate in the pilot Using a training protocol refined in the usability-testing phase of the project patients will be trained to use the smartphone and the wound surveillance app prior to discharge Patients will use the app from home to take send digital images of their postoperative wounds and answer a short survey all of which will be transmitted to a secure database maintained by the University of Wisconsin UW Department of Surgery and accessible only to UW-employed study personnel These data will be evaluated by one of three vascular surgery service nurse practitioners NPs daily and entered into the medical record Patients who have concerning findings either in their images or in their survey answers will be contacted for further evaluation Smartphones will be provided to patients who do not have one of their own through a partnership with ATT Sociodemographic and comorbidity data collected from the medical record will be kept at UW Department of Surgery on a secure server and accessible only to UW employed study personnel
Detailed Description:
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
Enrollmentbaseline 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 ruralurban status and 4G coverage and comorbidities particularly cognitive impairment and motor functioning impairment
Treatmentintervention period Regardless of where patients have been recruited and consented the patient andor 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 andor 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 patients 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 interventiontreatment 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 AimsStudy 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 phones camera role
Device specifications packaging labeling Smartphones will be iPhone 5s or 6 purchased through collaboration with ATT
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
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
Enrollmentbaseline 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 ruralurban status and 4G coverage and comorbidities particularly cognitive impairment and motor functioning impairment
Treatmentintervention period Regardless of where patients have been recruited and consented the patient andor 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 andor 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 patients 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 interventiontreatment 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 AimsStudy 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 phones camera role
Device specifications packaging labeling Smartphones will be iPhone 5s or 6 purchased through collaboration with ATT
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None