None listed
Conditions
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.
Interventions
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 co
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.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed