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Adaptive Intervention to Prevent Respiratory Illness in Cerebral Palsy: Protocol for a Feasibility Pilot Randomized
Alyssa Fleischman1, Carlos Lerner2, Heidi Kloster1
1Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.
Insights
This pilot study tests the Respiratory Exacerbation-Plans for Action and Care Transitions (RE-PACT) intervention to reduce severe respiratory illness in children with severe cerebral palsy (CP). Results are expected by late 2024.
Area of Science:
- Pediatric respiratory health
- Cerebral palsy management
- Health intervention research
Background:
- Children with severe cerebral palsy (CP) face high risks of severe respiratory illness.
- Current management strategies may not adequately prevent exacerbations and hospitalizations.
- A novel, adaptive intervention is needed to improve respiratory outcomes in this vulnerable population.
Purpose of the Study:
- To pilot-test the feasibility, acceptability, and fidelity of the RE-PACT intervention.
- To preliminarily estimate the effect size of RE-PACT on severe respiratory illness in children with severe CP.
- To refine the intervention protocol based on ongoing trial data.
Main Methods:
- Recruitment of up to 90 caregivers of children (0-17 years) with severe CP from UW and UCLA.
- Randomized assignment to either usual care or the RE-PACT intervention.
- RE-PACT includes action planning, rapid clinical response, and weekly SMS surveillance; study conducted in 3 trial waves.
Main Results:
- Recruitment is on track, with 30/90 participants enrolled as of the reporting date.
- The final participant is expected to complete the study by April 30, 2024.
- Full data analysis and publication of results are anticipated by the end of 2024.
Conclusions:
- The just-in-time adaptive RE-PACT intervention shows promise for reducing severe respiratory illness in children with severe CP.
- This adaptive, proactive approach may be beneficial for managing high-risk pediatric populations.
- The study protocol can inform future research and clinical practice for managing acute exacerbations in children with CP.
Background:
This study will pilot-test an innovative just-in-time adaptive intervention to reduce severe respiratory illness among children with severe cerebral palsy (CP). Our intervention program, Respiratory Exacerbation-Plans for Action and Care Transitions (RE-PACT), delivers timely customized action planning and rapid clinical response when hospitalization risk is elevated.
Objective:
This study aims to establish RE-PACT's feasibility, acceptability, and fidelity in up to 90 children with severe CP. An additional aim is to preliminarily estimate RE-PACT's effect size.
Methods:
The study will recruit up to 90 caregivers of children with severe CP aged 0 to 17 years who are cared for by a respiratory specialist or are receiving daily respiratory treatments. Participants will be recruited from pediatric complex care programs at the University of Wisconsin-Madison (UW) and the University of California, Los Angeles (UCLA). Study participants will be randomly assigned to receive usual care through the complex care clinical program at UW or UCLA or the study intervention, RE-PACT. The intervention involves action planning, rapid clinical response to prevent and manage respiratory illness, and weekly SMS text messaging surveillance of caregiver confidence for their child to avoid hospitalization. RE-PACT will be run through 3 successively larger 6-month trial waves, allowing ongoing protocol refinement according to prespecified definitions of success for measures of feasibility, acceptability, and fidelity. The feasibility measures include recruitment and intervention time. The acceptability measures include recruitment and completion rates as well as intervention satisfaction. The fidelity measures include observed versus expected rates of intervention and data collection activities. The primary clinical outcome is a severe respiratory illness, defined as a respiratory diagnosis requiring hospitalization. The secondary clinical outcomes include hospital days and emergency department visits, systemic steroid courses, systemic antibiotic courses, and death from severe respiratory illness.
Results:
The recruitment of the first wave began on April 27, 2022. To date, we have enrolled 30 (33%) out of 90 participants, as projected. The final wave of recruitment will end by October 31, 2023, and the final participant will complete the study by April 30, 2024. We will start analyzing the complete responses by April 30, 2024, and the publication of results is expected at the end of 2024.
Conclusions:
This pilot intervention, using adaptive just-in-time strategies, represents a novel approach to reducing the incidence of significant respiratory illness for children with severe CP. This protocol may be helpful to other researchers and health care providers caring for patients at high risk for acute severe illness exacerbations.
Trial Registration:
ClinicalTrials.gov NCT05292365; https://clinicaltrials.gov/study/NCT05292365.
International Registered Report Identifier (Irrid):
DERR1-10.2196/49705.
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