The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000998448
Ethics application status
Approved
Date submitted
20/07/2016
Date registered
28/07/2016
Date last updated
6/05/2019
Date data sharing statement initially provided
6/05/2019
Date results information initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of using parent photographs of children's surgical wounds post discharge, for the diagnosis of infection and the affect on parental engagement: Woundies.
Scientific title
Efficacy of using parent photographs of children's surgical wounds post discharge, for the diagnosis of infection and the affect on parental engagement: Woundies.
Secondary ID [1] 289720 0
Nil
Universal Trial Number (UTN)
U1111-1185-4878
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-surgery wound infection 299552 0
Condition category
Condition code
Skin 299527 299527 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents of children undergoing a laparoscopic appendectomy will be trained on how to take medical photographs of their child’s wound site using a mobile phone the day after surgery and how to send them to a confidential email address.
A professional medical photographer will administer face-to-face training with parents for 30 minutes. Parents will be provided with a training aid Training Session Time 1: Facilitated by Kara Burns. This training includes a demonstration how to take a medical photograph on a mobile phone. Parents will then undertake the following activities will with supervision of the researcher:
Taking mobile phone photographs using a standardised methodology

Equipment
a. A Smart Phone: All smart phones have the technical ability to take medical images. The equipment you will use to take the images is the camera, the flash, the screen to focus the image and view your results and an email program to send the image to a secure email address
b. 15cm white self-adhesive scales: These are places on the wound site to aid camera focus, colour correction and improve the accuracy of detecting healing rates. One is required per photo session.
c. The Secure Email Address: woundies@health.qld.gov.au

Mobile Phone Camera Settings
1. Turn on the phone
2. Open the camera application provided by your manufacturer
3. Turn the flash to ON
4. Turn off all other settings
5. Use the ‘Portrait’ image dimension setting

Lighting conditions
The main light source is the mobile phone camera flash. This provides a standard light source. Always photograph indoors, turn on all over head lights and open any curtains, however you should avoid direct sunlight and bright overhead spot lights to minimise over-exposure.

Positioning of your child
When working with children, prior to taking any photographs, reassure the child the process will be quick and painless. Position your child comfortably on the floor, bed or change table with a neutral background (preferably white) beneath the site to be photographed. Remove any clothing, nappies or dressings covering the surgical site. When photographing place yourself above the surgical site as shown in the illustration below. To maximise sharpness and depth of field, the camera lens plane must be positioned parallel to the wound plane.

Photography technique
Place a 15 cm white scale in a horizontally across the child’s abdomen as shown in the diagram below. The 0mm mark should be at the furthest left hand point of the wound site and as close as possible to the bottom of the lowest point of the wound site without obscuring any edges of the lesion. Position the camera to capture the scale with the 0 and 15 cm marking the edge of the photo frame making sure the camera is parallel to the abdomen. Once the frame is positioned place your finger on the screen to focus on the scale. Once focussed take an image.

A minimum of three images should be taken at each time point to ensure that at least one adequate image was available for review, a technique known as bracketing. Check each image and if unclear, blurred, dark or too light, repeat the process until a satisfactory image is gained. Take follow up images of the same site using the same technique on day 2,4,6 and 10 after surgery (or if you are worried). For consistency of check the orientation of previous images before capturing the next image.

Emailing the Images
1. Open the mail application provided by your manufacturer on your smart phone
2. Create an email and send to the address: woundies@health.qld.gov.au
3. Put in the subject line your participant ID number ( ) and day when the photo was taken (e.g. ID , Day 0)
4. Insert the image as an attachment into the email
5. Send the email

Parents will be asked to repeat this process at home on day 2, 4, 6 and 10 days after the operation from home.
Images will be assessed for infection by surgical staff Dr Bhavesh Patel and Dr Craig McBride using the standardised SSI criteria form the Centre for Disease Control (USA) http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf
This stipulates that an SSI must be an infection occurs within 30 days after any operative procedure (where day 1 = the procedure date) and involves only skin and subcutaneous tissue of the incision and the patient has at least one of the following:
a. purulent drainage from the superficial incision.
b. organisms identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (e.g., not Active Surveillance Culture/Testing (ASC/AST).
c. superficial incision that is deliberately opened by a surgeon, attending physician or other designee and culture or non-culture based testing is not performed.

And the patient has at least one of the following signs or symptoms:
a. pain or tenderness; localized swelling; erythema; or heat.
b. diagnosis of a superficial incisional SSI by the surgeon or attending physician** or other designee.

Adherence will not be monitored, however it will be assessed as a secondary outcome at the end of the trial using a questionnaire and interviews to establish parental engagement.
Intervention code [1] 295357 0
Other interventions
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299007 0
Detection of surgical site infection using parental photographs
Timepoint [1] 299007 0
14 days after surgery
Secondary outcome [1] 325859 0
Level of engagement, assessed by changes between Questionnaire Time 1 (1st Photograph) and Questionnaire Time 3 (approximately 14 days after surgery). These items will be assessed by researcher Kara Burns and short interviews will be done to establish if engagement occurred. The questionnaire was developed for this research,
Timepoint [1] 325859 0
Questionnaire T1: 1 day after surgery
Questionnaire T2: 14 days after surgery
Interview: 21 days after surgery

Eligibility
Key inclusion criteria
Parents of children undergoing laparoscopic appendectomy.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
LOTE parents are excluded from this pilot project. The qualitative aspects of the interview make this pragmatically difficult.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This pilot will take an 'all-comers' approach. No allocation concealment will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This pilot will take an 'all-comers' approach. No sequence generation will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Primary Outcome: Visual inspection of parental images to detect surgical site infections
Secondary Outcome: Qualitative analysis based on interviews driven by changes in a test-retest design questionnaire

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6230 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 13647 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 294141 0
Self funded/Unfunded
Name [1] 294141 0
Unfunded
Address [1] 294141 0
Unfunded
Country [1] 294141 0
Primary sponsor type
University
Name
Queensland University of Technology
Address
QUT Business School
GPO Box 2434
Brisbane 4001
Country
Australia
Secondary sponsor category [1] 292935 0
Hospital
Name [1] 292935 0
Lady Cilento Children's Hospital
Address [1] 292935 0
7D Surgical Directorate
501 Stanley Street
South Brisbane, Qld, 4101
Australia
Country [1] 292935 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295515 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC)
Ethics committee address [1] 295515 0
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 295515 0
Australia
Date submitted for ethics approval [1] 295515 0
06/06/2016
Approval date [1] 295515 0
20/07/2016
Ethics approval number [1] 295515 0
TBA

Summary
Brief summary
The aims of the project are twofold
1. To determine the true Surgical Site Infection incidence in children following Paediatric Surgical operations at Lady Cilento Children's Hospital, using parent-taken photographs of the wounds that are then uploaded to a secure site for review.
2. To determine if this extension of hospital and departmental care alters parental perception of their engagement with the hospital, assessed via qualitative methods.

This project is a pilot study, with a view to a larger 'all-comers' cohort study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67570 0
Ms Kara Burns
Address 67570 0
QUT Business School
GPO Box 2434
Brisbane QLD 4001
Country 67570 0
Australia
Phone 67570 0
+61 414 294 967
Fax 67570 0
Email 67570 0
kara.burns@hdr.qut.edu.au
Contact person for public queries
Name 67571 0
Ms Kara Burns
Address 67571 0
QUT Business School
GPO Box 2434
Brisbane QLD 4001
Country 67571 0
Australia
Phone 67571 0
+61 414 294 967
Fax 67571 0
Email 67571 0
kara.burns@hdr.qut.edu.au
Contact person for scientific queries
Name 67572 0
Dr Craig A. McBride
Address 67572 0
Children's Health Queensland
Surgical Team: Infants, Toddlers, Children
7d Surgical Directorate
501 Stanley St, South Brisbane, Qld 4101
Country 67572 0
Australia
Phone 67572 0
+61 411 743 219
Fax 67572 0
Email 67572 0
cmcbride@paedsurgery.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 2000 0
Burns K, McBride CA, Patel B, FitzGerald G, Mathews S, Drennan J
Creating Consumer Generated Health Data: Interviews and a Pilot Trial Exploring How and Why People Engage. Journal of Medical Internet Research. (forthcoming/in press)
DOI: 10.2196/12367

URL: https://preprints.jmir.org/preprint/12367
Attachments [1] 2000 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Background
Consumer Generated Health Data (CGHD) are any clinically relevant data collected by patients or their carers (consumers) that may improve healthcare outcomes. Like patient experience measures, this data reflects the consumer perspective and is part of a patient-centric agenda. The use of CGHD is believed to enhance diagnosis, patient engagement and thus foster an improved therapeutic partnership with healthcare providers.

Objective
The aim of this study is to further identify how this data is used by consumers and how it influences engagement via a validated framework. Additionally, carer data has not been explored for the purpose of engagement.

Methods
Study 1 used interviews with CGHD-experienced patients, carers and doctors to understand attitudes about data collection and use, developing an ontological framework. Study 2 was a pilot trial with carers (parents) of children undergoing laparoscopic appendectomy. For ten days carers generated and emailed surgical site photographs to a tertiary children’s hospital. Subsequently carers were interviewed about the engagement framework. In total, 60 interviews were analysed using theme and content analysis.

Results
This paper validates a framework anchored in engagement literature which categorises CGHD engagement outcomes into four domains; physiological, cognitive, emotional and behavioural. CGHD use is a complex, interconnected and can be organised into 10 themes within these four domains.

Conclusion
Consumer generated health data can instigate an ‘ecosystem’ of engagement and provide clinicians with an enhanced therapeutic relationship through an extended view into the patient’s world. In addition to clinical diagnosis and efficient use of healthcare resources, data offers another tool to manage consumers service experience, especially the emotions associated with the healthcare journey. Collection and use of data increases consumers sense of reassurance, improves communication with providers and promotes greater personal responsibility, indicating an empowering consumer process. Lastly, it can also improve confidence and satisfaction in the service.