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Trial registered on ANZCTR


Registration number
ACTRN12614000940673
Ethics application status
Approved
Date submitted
21/08/2014
Date registered
2/09/2014
Date last updated
2/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychosocial Screening for Burns Patients
Scientific title
A Quality Improvement Study on Psychosocial Screening and Outcome Tracking Following Severe Burn Injury
Secondary ID [1] 285147 0
N/A
Universal Trial Number (UTN)
U1111-1160-2858
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post traumatic stress disorder (PTSD) 292733 0
Depression 292734 0
Anxiety 292735 0
Adjustment and Quality of Life 292736 0
Burn Injury 292737 0
Condition category
Condition code
Mental Health 293028 293028 0 0
Depression
Mental Health 293029 293029 0 0
Anxiety
Injuries and Accidents 293030 293030 0 0
Burns

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6 years
Target follow-up type
Years
Description of intervention(s) / exposure
Collection of non-identified data from burn survivors. Data sets include:
1. Demographic data
2. Injury/hospitalisation data including TBSA, length of stay, need for surgery
3. Mental health/trauma symptoms including post-traumatic stress, depression, anxiety, coping
4. Measurement of quality of life post-injury

Screening will be done at 2-4 weeks post injury and then every 3 months in the first year and then annualy for 5 years. Each screening visit on average takes between 30 minutes to 1 hour.
Intervention code [1] 289997 0
Not applicable
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292894 0
Mental health sequelae following severe burns injury (PTSD, Depression & Anxiety)

First measurement point will be from thr routine psychiatric assesment of each individual patient, which is part of standard care.

Measurements to be used:
1. Demographic and medical details: A questionnaire that updates demographic details, records pain levels, drug and alcohol use and current health care utilisation. This form is completed by members of the research team utilising data linkage to participants medical records.

2. Mental health disorders screening form: The Consultation –Liaison psychiatry team screens burns patients and this information on current absence/presence and type of mental health disorder is recorded

3. ABCDSelf Report, revised (ABCD-SRR): A short self-report scale that identifies an adult’s attachment style hat predicts aspects of outcome and can help formulate treatment. It was revised to be shortened on the basis of results from the group’s Adjustment to Burns study.

4. The Depression Anxiety and Stress Schedule (DASS): a valid and reliable self-report measure for symptoms of depression, anxiety and stress. As depression is often a sequel of trauma and post-traumatic symptoms, we wish to track these symptoms in our cohort as well as anxiety and a measure of subjective stress. This is self reported by the participants.

5.Impact of Event Scale (IES): This 15-item widely used self-report questionnaire is a reliable measure of subjective posttraumatic stress to a traumatic or stressful life event . This is self reported by the participant.
Timepoint [1] 292894 0
Every 3 months in the first year post injury and then annually for 5 years.
Primary outcome [2] 292895 0
Coping and adjustment to Severe Burns Injury

Measurements to be used:
1. COPE :a valid and reliable self-report questionnaire measure of coping style. As coping style impacts on recovery from burns and avoidant strategies markedly impact on recovery,we wish to track this and other coping strategies that may impact on the recovery of our cohort.

2. DS-16: A self-report questionnaire that identifies a type of personality style with high negative affect and reduced use of social coping. This is included for the recognition of an at risk group, suggested in our recent work.

3. Relationships Questionnaire (RQ): This questionnaire describes how patients feel in close relationships and predicts aspects of psychosocial symptoms as confirmed in our recent work.
4. Measure of Alcohol use (AUDIT) ie to measure alcohol use as a way of 'coping'
Timepoint [2] 292895 0
Every 3 months in the first year and then annually for 5 years.
Primary outcome [3] 292896 0
Quality of life after a severe burn injury.
The Burn Specific Health Scale-Brief (BSHS-B), which measures quality of life post burns will be used.
Timepoint [3] 292896 0
Quality of life will be assessed at one single timepoint between 12-18 months post injury. Some flexibility of time will be required, given the varrying timepoints participanst return at this time post injury.
Secondary outcome [1] 309885 0
Return to work
The Burn Specific Health Scale-Brief (BSHS-B), which looks at return to work and adjustment.
Timepoint [1] 309885 0
Return to work will be assessed at one single timepoint between 12-18 months post injury. Some flexibility of time will be required, given the varrying timepoints participanst return at this time post injury.

Eligibility
Key inclusion criteria
Inclusion criteria is 1) Ability to consent to participate to this screening study and 2) Admission to the Severe Burn Injury at Royal North Shore Hospital with a burn injury. Criteria for admission to a specialist burn unit is as follows:
any intubated patient,
inhalation injuries with cutaneous burns,
head and neck, hand, face or genital burns,
mid-dermal, deep dermal or full thickness burns equal or greater than 20%,
burns with significant co-morbidities,
associated trauma,
circumferential burn to limbs or chest that compromises, circulation or respiration,
all electrical and chemical burn injuries
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients younger than 18 years of age and those with issues that impair the ability to give informed consent will be excluded. We are wanting to screen all burns patients admitted to the Severe Burns Injury Unit

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We will aim to analyse the data set and data cohorts over time looking at predictors of post-traumatic symptoms, depression, anxiety and quality of life parameters, using regression and logistic regression models. We aim to recruit the majority of SBIU patients and follow them longitudinally. In terms of recruitment, we are aiming for close to full screening of target group, which is all patients admitted to the Severe Burns Injury Unit at Royal North Shore Hospital. Historically this is an average of 200 patients a year. We plan to recruit all patients admitted, in the first year 200, in the second year 400 and the third year 600.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2831 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 8521 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [2] 8522 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 289759 0
Government body
Name [1] 289759 0
The NSW Institute of Psychiatry
Country [1] 289759 0
Australia
Primary sponsor type
Government body
Name
The NSW Institute of Psychiatry
Address
Cumberland Hospital Campus
1 Fleet Street
North Parramatta
NSW 2151
Country
Australia
Secondary sponsor category [1] 288449 0
Hospital
Name [1] 288449 0
Royal North Shore Hospital
Address [1] 288449 0
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Country [1] 288449 0
Australia
Secondary sponsor category [2] 288450 0
University
Name [2] 288450 0
The University of Sydney
Address [2] 288450 0
The University of Sydney,
City Road
NSW 2006
Country [2] 288450 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291492 0
Human Research Ethics Committee of Northern Sydney Central Coast
Ethics committee address [1] 291492 0
Ethics committee country [1] 291492 0
Date submitted for ethics approval [1] 291492 0
31/03/2014
Approval date [1] 291492 0
15/07/2014
Ethics approval number [1] 291492 0
HREC/14/HAWKE/79

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 158 158 0 0
/AnzctrAttachments/366892-Letter - HREC FINAL approval - HREC Exec meeting OOS 14 July 2014 - RESP 14 57[1].pdf
Attachments [2] 159 159 0 0
/AnzctrAttachments/366892-Protocol_.docx
Attachments [3] 160 160 0 0
/AnzctrAttachments/366892-PISCF.docx

Contacts
Principal investigator
Name 50626 0
A/Prof Loyola McLean
Address 50626 0
Consultation Liaison Psychiatry
Acute Services Building, Level 3
Reserve Rd
Royal North Shore Hospital St Leonards,
NSW 2065
Country 50626 0
Australia
Phone 50626 0
61 2 99267111
Fax 50626 0
Email 50626 0
[email protected]
Contact person for public queries
Name 50627 0
Julia Kwiet
Address 50627 0
Department of Social Work
Building/Block 30
Royal North Shore Hospital
Reserve Rd
St Leonards, NSW, 2065
Country 50627 0
Australia
Phone 50627 0
61 2 9462 9477
Fax 50627 0
61 2 9463 1020
Email 50627 0
[email protected]
Contact person for scientific queries
Name 50628 0
Loyola McLean
Address 50628 0
Consultation Liaison Psychiatry
Acute Services Building
Reserve Rd
Royal North Shore Hospital St Leonards,
NSW 2065
Country 50628 0
Australia
Phone 50628 0
61 2 99267111
Fax 50628 0
Email 50628 0
[email protected]

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