JMIR Publications

ABSTRACT

Background:

This study will pilot test an innovative just-in-time adaptive intervention to reduce severe respiratory illness for children with severe cerebral palsy (CP). Our intervention program, RE-PACT (Respiratory Exacerbation – Plans for Action and Care Transitions), delivers timely, customized action planning and rapid clinical response when hospitalization risk is elevated.

Objective:

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:

RE-PACT will be run through three successively larger 6-month trial waves, allowing ongoing protocol refinement according to pre-specified definitions of success for measures of feasibility, acceptability, and fidelity.

Results:

Feasibility measures include recruitment and intervention time. Acceptability measures include recruitment and completion rates as well as intervention satisfaction. 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. Secondary clinical outcomes include hospital days and emergency department visits, systemic steroid courses, systemic antibiotic courses, and death from severe respiratory illness.

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 cerebral palsy. This protocol may be helpful to other researchers and healthcare providers caring for patients at high risk for acute severe illness exacerbations. Clinical Trial: ClinicalTrials.gov NCT05292365