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)
| Autor: | Tania Zappala, Robert S. Ware, Steven M. McPhail, Gillian Harvey, Zephanie Tyack, Roy M. Kimble, Megan Simons |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Telemedicine Context (language use) paediatric dermatology organisation of health services law.invention Feedback 03 medical and health sciences 0302 clinical medicine Quality of life (healthcare) Randomized controlled trial law medicine Outpatient clinic Humans 030212 general & internal medicine Patient Reported Outcome Measures Child Randomized Controlled Trials as Topic business.industry 030503 health policy & services change management Australia Paediatrics General Medicine Electronic patient-reported outcome Clinical trial Family medicine Quality of Life Medicine Implementation research Queensland telemedicine Electronics 0305 other medical science business |
| Zdroj: | BMJ Open BMJ Open, Vol 11, Iss 4 (2021) |
| ISSN: | 2044-6055 |
| Popis: | IntroductionUsing patient-reported outcome measures (PROMs) with children have been described as ‘giving a voice to the child’. Few studies have examined the routine use of these measures as potentially therapeutic interventions. This study aims to investigate: (1) the effectiveness of feedback using graphical displays of information from electronic PROMs (ePROMs) that target health-related quality of life, to improve health outcomes, referrals and treatment satisfaction and (2) the implementation of ePROMs and graphical displays by assessing acceptability, sustainability, cost, fidelity and context of the intervention and study processes.Methods and analysisA hybrid II effectiveness-implementation study will be conducted from February 2020 with children with life-altering skin conditions attending two outpatient clinics at a specialist paediatric children’s hospital. A pragmatic randomised controlled trial and mixed methods process evaluation will be completed. Randomisation will occur at the child participant level. Children or parent proxies completing baseline ePROMs will be randomised to: (1) completion of ePROMs plus graphical displays of ePROM results to treating clinicians in consultations, versus (2) completion of ePROMs without graphical display of ePROM results. The primary outcome of the effectiveness trial will be overall health-related quality of life of children. Secondary outcomes will include other health-related quality of life outcomes (eg, child psychosocial and physical health, parent psychosocial health), referrals and treatment satisfaction. Trial data will be primarily analysed using linear mixed-effects models; and implementation data using inductive thematic analysis of interviews, meeting minutes, observational field notes and study communication mapped to the Consolidated Framework for Implementation Research.Ethics and disseminationEthical approval was obtained from Children’s Health Queensland Human Research Ethics Committee (HREC/2019/QCHQ/56290), The University of Queensland (2019002233) and Queensland University of Technology (1900000847). Dissemination will occur through stakeholder groups, scientific meetings and peer-reviewed publications.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12620000174987). |
| Databáze: | OpenAIRE |
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