Effectiveness-implementation hybrid-2 randomised trial of a collaborative Shared Care Model for Detecting
Debbie Long1,2, Kristen Gibbons3, Belinda Dow4
1School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia da.long@qut.edu.au.
Insights
This pilot study tested a shared care model for neurodevelopmental follow-up in young children after paediatric intensive care. The goal is to improve long-term outcomes for these vulnerable survivors.
Area of Science:
- Pediatric critical care medicine
- Neurodevelopmental disorders
- Implementation science
Background:
- Paediatric intensive care unit (PICU) survivors face significant long-term neurodevelopmental impairment, impacting life opportunities.
- Standardized neurodevelopmental follow-up for PICU survivors is lacking, with limited evidence on optimal methods.
- Early identification and intervention are crucial for mitigating long-term effects of critical illness in children.
Purpose of the Study:
- To pilot a collaborative, multidisciplinary neurodevelopmental follow-up model for young children post-PICU discharge.
- To assess the feasibility of a combined online screening platform and general practitioner (GP) shared care approach.
- To evaluate neurodevelopmental vulnerability, parental stress, and influencing risk factors in two intervention groups.
Main Methods:
- A single-centre, randomized effectiveness-implementation (hybrid-2) pilot trial involving parents of children aged 2 months to 4 years discharged from PICU.
- Intervention group: 6 months of collaborative shared care with GPs, supported by online monitoring.
- Control group: Self-directed screening and education on post-intensive care syndrome and child development.
- Follow-up at 1, 3, and 6 months post-discharge; primary outcome is feasibility; secondary outcomes include neurodevelopmental vulnerability and parental stress.
Main Results:
- Feasibility of the shared care model is the primary outcome to be assessed.
- Secondary outcomes will measure differences in neurodevelopmental vulnerability and parental stress between groups.
- An implementation evaluation will identify barriers and facilitators to the intervention's adoption.
Conclusions:
- This pilot study aims to inform a larger trial on effective follow-up models for critically ill children.
- Findings will guide clinical practice and policy for neurodevelopmental care of PICU survivors.
- Successful implementation could improve long-term outcomes and quality of life for children after critical illness.
Introduction:
In Australia, while paediatric intensive care unit (PICU) mortality has dropped to 2.2%, one in three survivors experience long-term neurodevelopmental impairment, limiting their life-course opportunities. Unlike other high-risk paediatric populations, standardised routine neurodevelopmental follow-up of PICU survivors is rare, and there is limited knowledge regarding the best methods. The present study intends to pilot a combined multidisciplinary, online screening platform and general practitioner (GP) shared care neurodevelopmental follow-up model to determine feasibility of a larger, future study. We will also assess the difference between neurodevelopmental vulnerability and parental stress in two intervention groups and the impact of child, parent, sociodemographic and illness/treatment risk factors on child and parent outcomes.
Methods And Analysis:
Single-centre randomised effectiveness-implementation (hybrid-2 design) pilot trial for parents of children aged ≥2 months and <4 years discharged from PICU after critical illness or injury. One intervention group will receive 6 months of collaborative shared care follow-up with GPs (supported by online outcome monitoring), and the other will be offered self-directed screening and education about post-intensive care syndrome and child development. Participants will be followed up at 1, 3 and 6 months post-PICU discharge. The primary outcome is feasibility. Secondary outcomes include neurodevelopmental vulnerability and parental stress. An implementation evaluation will analyse barriers to and facilitators of the intervention.
Ethics And Dissemination:
The study is expected to lead to a full trial, which will provide much-needed guidance about the clinical effectiveness and implementation of follow-up models of care for children after critical illness or injury. The Children's Health Queensland Human Research Ethics Committee approved this study. Dissemination of the outcomes of the study is expected via publication in a peer-reviewed journal, presentation at relevant conferences, and via social media, podcast presentations and open-access medical education resources.
Registration Details:
The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry as 'Pilot testing of a collaborative Shared Care Model for Detecting Neurodevelopmental Impairments after Critical Illness in Young Children' (the DAISY Pilot Study).
Trial Registration Number:
ACTRN12621000799853.
