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Trial registered on ANZCTR

Registration number

ACTRN12620000174987

Ethics application status

Approved

Date submitted

23/01/2020

Date registered

17/02/2020

Date last updated

17/02/2020

Date data sharing statement initially provided

17/02/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Using responses to child and caregiver questionnaires about quality of life in hospital consultations

Scientific title

Using patient-reported outcome measures for children with life-altering skin conditions in routine clinical practice: A pilot randomised effectiveness-implementation study

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

PEDS-ePROM

Linked study record

Health condition

Health condition(s) or problem(s) studied:

burn scars

infantile haemangiomas

Condition category

Condition code

Skin

Dermatological conditions

Injuries and Accidents

Burns

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A generic and disease-specific health-related quality of life measures will be completed by children or caregivers at each appointment. Each questionnaire will take approximately 5-10 mins to complete, to be completed at or prior to scheduled appointments over a 3 month period. A result summary will be printed and handed to children and parents and treating clinicians immediately after completion of the PROMs and stored in electronic medical records. The PROMs to be implemented will be chosen considering local staff preferences, measures routinely used, consumer priorities, the inclusion of emotional functioning to confirm the positive findings of previous paediatric studies, and reliability or responsiveness. Decisions regarding the PROMs and graphical displays to be included will be confirmed prior to the randomised controlled trial starting based on interviews with treating health professionals and children with skin conditions and their families. The generic measure will be the Pediatric Quality of Life Evaluation (PEDS-QL) infant and generic scales. Disease-specific measures will be the Brisbane Burn Scar Impact Profile and Infantile Haemangioma Quality of Life questionnaire; with content validity supported by involvement of the target group. The CARE parent scale and Hemangioma Family Burden questionnaire items will be completed by caregivers of children with burn scars about themselves or their family. There will also be an open ended option for child and caregiver participants to report their priorities for care. The PROMs will be administered electronically on iPads using the Qualtrix program via a weblink sent to child and/or caregiver participants in the two days prior to their appointment. If the questionnaires are not completed via the weblink child and caregiver participants will be offered a further opportunity to complete the questionnaires up to 30 minutes prior to their consultation at the outpatient clinic while they are waiting in the waiting area. Result summaries (graphical displays of the data) will be generated using the Qualtrix programs and presented to treating health professionals, caregivers and children (where appropriate). After consultations caregivers and children (where appropriate) will be asked to report the topics that were discussed during the consultation mapped to the graphical display items. Copies of the electronically completed patient-reported outcome measures and graphical summaries will be stored in medical records.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

The treatment for the control group will be the same as the PEDS-ePROM intervention with the exception that result summaries will not be presented at consultations but will be provided to child and caregiver participants at the end of the study (after the 3month intervention and 3 month follow-up period).

Control group

Active

Outcomes

Primary outcome [1]

generic child overall health-related quality of life (PEDS-QL - total score)

Timepoint [1]

baseline, 3 months and 6 months post-baseline

Secondary outcome [1]

Child physical health-related quality of life (physical summary score of the PEDS-QL)

Timepoint [1]

baseline, 3 months and 6-months post-baseline

Secondary outcome [2]

Child psychosocial health-related quality of life (psychosocial summary score of the PEDS-QL)

Timepoint [2]

baseline, 3 months and 6 months post-baseline

Secondary outcome [3]

Child overall quality of life (health utility score - CHU-9D)

Timepoint [3]

baseline, 3 months and 6 months post-baseline

Secondary outcome [4]

Disease specific health-related quality of life (child overall impact) - Brisbane Burn Scar Impact Profile overall impact subscale [burn scar clinic group only]

Timepoint [4]

baseline, 3 months and 6 months post-baseline (plus at each consultation)

Secondary outcome [5]

Disease specific health-related quality of life (child sensory intensity) - Brisbane Burn Scar Impact Profile sensory intensity subscale [burn scar clinic group only]

Timepoint [5]

baseline, 3 months and 6 months post-baseline

Secondary outcome [6]

Disease specific health-related quality of life (child sensory frequency) - Brisbane Burn Scar Impact Profile sensory frequency subscale [burn scar clinic group only]

Timepoint [6]

baseline, 3 months and 6 months post-baseline

Secondary outcome [7]

Disease specific health-related quality of life (child sensory impact) - Brisbane Burn Scar Impact Profile sensory impact subscale [burn scar clinic group only]

Timepoint [7]

baseline, 3-months and 6-months post-baseline

Secondary outcome [8]

Disease specific health-related quality of life (child mobility) - Brisbane Burn Scar Impact Profile mobility subscale [burn scar clinic group only]

Timepoint [8]

baseline, 3-months and 6-months post-baseline

Secondary outcome [9]

Disease specific health-related quality of life (child daily living) - Brisbane Burn Scar Impact Profile daily living subscale [burn scar clinic group only]

Timepoint [9]

baseline, 3-months and 6-months post-baseline

Secondary outcome [10]

Disease specific health-related quality of life (child friendships and social interaction) - Brisbane Burn Scar Impact Profile friendships and social interaction subscale [burn scar clinic group only]

Timepoint [10]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [11]

Disease specific health-related quality of life (child appearance) - Brisbane Burn Scar Impact Profile appearance subscale [burn scar clinic group only]

Timepoint [11]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [12]

Disease specific health-related quality of life (child emotional reactions) - Brisbane Burn Scar Impact Profile emotional reactions subscale [burn scar clinic group only]

Timepoint [12]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [13]

Disease specific health-related quality of life (child physical symptoms) - Brisbane Burn Scar Impact Profile physical symptoms subscale [burn scar clinic group only]

Timepoint [13]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [14]

Disease specific health-related quality of life (parent worry) - Brisbane Burn Scar Impact Profile parent worry subscale [burn scar clinic group only]

Timepoint [14]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [15]

Disease specific health-related quality of life (parent impact) - Brisbane Burn Scar Impact Profile parent impact subscale [burn scar clinic group only]

Timepoint [15]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [16]

Overall satisfaction with treatment measured using a single item immediately after a consultation (designed specifically for this study).

Timepoint [16]

Baseline, and immediately after each consultation.

Secondary outcome [17]

Disease specific health-related quality of life (child physical symptoms) -Infantile Hemangioma Quality of Life Scale child physical symptoms [infantile hemangioma vascular clinic group only]

Timepoint [17]

baseline, 3-months and 6-months post-baseline

Secondary outcome [18]

Disease specific health-related quality of life (child social interactions) -Infantile Hemangioma Quality of Life Scale child social interactions subscale [infantile hemangioma vascular clinic group only]

Timepoint [18]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [19]

Disease specific health-related quality of life (parent emotional functioning) -Infantile Hemangioma Quality of Life Scale parent emotional functioning subscale [infantile hemangioma vascular clinic group only]

Timepoint [19]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [20]

Disease specific health-related quality of life (parent psychosocial functioning) -Infantile Hemangioma Quality of Life Scale parent psychosocial functioning subscale [infantile hemangioma vascular clinic group only]

Timepoint [20]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [21]

Disease specific health-related quality of life (parent negative mood) - CARe parent questionnaire negative mood subscale [burn scar clinic group only]

Timepoint [21]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [22]

Disease specific health-related quality of life (parent self worth) - CARe parent questionnaire self-worth subscale [burn scar clinic group only]

Timepoint [22]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [23]

Disease-specific health-related quality of life (relationships and work family burden) - Hemangioma Family Burden questionnaire relationships and work subscale

Timepoint [23]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [24]

Disease-specific health-related quality of life (budget impact) - Hemangioma Family Burden questionnaire budget item

Timepoint [24]

Baseline, 3-months and 6-months post-baseline

Secondary outcome [25]

Number and type of referrals

Timepoint [25]

baseline to 3-months post-burn and baseline to 6-months post-burn

Eligibility

Key inclusion criteria

Children with burn scars and infantile haemangiomas (and their caregivers)
Aged 16 years or younger at the time of recruitment
Ongoing management in the outpatient hospital setting
Caregivers of children requiring ongoing management in the hospital setting

Minimum age

0 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Involvement with Child Safety
Unable to obtain consent
Inability to provide informed consent (i.e., diminished understanding or comprehension)
Difficulty speaking or understanding written English

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratified allocation will be used in the study with clinic as the unit of stratification. Randomisation will be at the level of the individual in random blocks.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Generalised linear mixed models for repeated measures will be used, accounting for clustering within clinics and within treating health professionals, with terms included for stratification and confounding variables (if any differences between groups are identified for key sociodemographic and clinical characteristics at baseline). Framework analysis will be used to analyse the qualitative data mapping this to theoretical frameworks where appropriate. Credibility of qualitative analyses will be checked using member checking, independent coding of the data by two researchers, triangulation of the results across participant groups and reflective journaling.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

31/01/2020

Date of last participant enrolment

Anticipated

31/08/2020

Actual

Date of last data collection

Anticipated

26/02/2021

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Queensland Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Children's Hospital Foundation

Address [1]

501 Stanley St, South Brisbane, QLD 4101

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

Child Health Research Centre, 62 Graham St, South Brisbane, QLD 4101

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Children's Health Queensland

Address [1]

Queensland Children's Hospital, 501 Stanley St, South Brisbane QLD 4101.

Country [1]

Australia

Secondary sponsor category [2]

Hospital

Name [2]

Queensland University of Technology

Address [2]

149 Victoria Park Rd, Kelvin Grove QLD 4059

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Queensland Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

Level 7, Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
62 Graham Street, South Brisbane QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/08/2019

Ethics approval number [1]

Summary

Brief summary

This study is hybrid II effectiveness-implementation study with data collected in outpatient clinics at a specialist paediatric children’s hospital. The study will involve a pragmatic randomised controlled trial which will be conducted after the intervention is refined using interviews, underpinned by the Consolidated Framework for Implementation Research framework, and conducted with a sample of children with skin conditions. A mixed methods process evaluation and cost effectiveness analysis will be conducted. Children will be randomised to one of two intervention groups: completion of patient-reported outcome measures plus graphical displays of patient-reported outcome measure information provided to caregivers, older children and treating clinicians in consultations versus completion of PROMs without graphical display of the information in consultations (results will be provided at the end of the study). The primary outcome of the effectiveness trial will be overall health-related quality of life of children.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Zephanie Tyack

Address

The University of Queensland, 62 Graham St, South Brisbane, QLD 4101

Country

Australia

Phone

+61 30697446

Fax

[email protected]

Contact person for public queries

Name

Zephanie Tyack

Address

The University of Queensland, 62 Graham St, South Brisbane, QLD 4101

Country

Australia

Phone

+61 7 3069 7446

Fax

[email protected]

Contact person for scientific queries

Name

Zephanie Tyack

Address

The University of Queensland, 62 Graham St, South Brisbane, QLD 4101

Country

Australia

Phone

+61 7 3069 7446

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Quantitative data from the randomised controlled trial will be shared with appropriate permissions.

When will data be available (start and end dates)?

Data will be available beginning 3 months and ending 5 years following main results publication (likely from 2022).

Available to whom?

Data will be available to researchers who have obtained the appropriate permissions to access the data and who agree to specific conditions for accessing the data.

Available for what types of analyses?

Quantitative analyses

How or where can data be obtained?

Dr Zephanie Tyack
Email: [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5520	Study protocol				This document will be uploaded once published.
5521	Statistical analysis plan				This document will be uploaded prior to the end of... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Improving the patient-centred care of children with life-altering skin conditions using feedback from electronic patient-reported outcome measures: Protocol for a hybrid effectiveness-implementation study (PEDS-ePROM).	2021	https://dx.doi.org/10.1136/bmjopen-2020-041861

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically