Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe CP

Study Overview
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Brief Summary
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This study will pilot test a just-in-time (JIT) adaptive intervention to reduce severe respiratory illness, for children with severe cerebral palsy (CP). The intervention program, called RE-PACT, delivers timely, customized action planning and health coaching when mobile text messaging with families predicts hospitalization risk is elevated. A total of n=90 caregivers of children with severe CP will be enrolled from the University of Wisconsin-Madison (UW) and the University of California, Los Angeles (UCLA) and can expect to be on study for up to 6 months.

Detailed Description
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The two-site study takes place at clinical programs at US children's hospitals: the UW and UCLA Pediatric Complex Care Pro-grams were each established to deliver care to children with medical complexity. Each program is comprised of primary care providers, care coordinators, and extended visit lengths, deliver comprehensive care to children with cerebral palsy. These sites have existing collaborative relationships through their participation in the CYSHCNet national research network (http://cyshcnet.org) and other federally funded initiatives, and a track record of successful productive scientific collaboration. The study period will be divided into three waves: after each wave, feasibility, acceptability, and fidelity data will be reviewed against pre-defined measures of success to adjust the protocol and overcome implementation barriers. This study will be conducted through a six-month randomized pilot trial. Briefly, after recruitment and baseline assessments, eligible caregiver/child dyads are randomized to intervention (I) or active control (AC). Intervention subjects receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. AC subjects will receive usual comprehensive medical care and coordination. Assessments of feasibility, acceptability and fidelity, as well as clinical outcomes, will be conducted at baseline and monthly intervals for 6 months. Intervention outcomes will be evaluated at baseline (i.e., randomization) and 6 months post-enrollment, and will also include the primary clinical outcome (i.e., hospitalization for respiratory diagnosis).

Official Title
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Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe Cerebral Palsy (CP)

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Behavioral: RE-PACT Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age Primary caregiver to an eligible child (child criteria below) Speak English or Spanish well enough to be interviewed Have a phone capable of sending/receiving text messages Has a child age 0-17 years with Gross Motor Function Classification System level IV or V Cerebral Palsy Cared for by respiratory specialist or receive daily respiratory treatments (oxygen, ventilation, airway clearance device, medications) Exclusion Criteria: Lack of interest in text messaging or coaching interactions during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: eligible caregiver/child dyads are randomized to intervention or active control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RE-PACT Intervention<br>Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. | Behavioral: RE-PACT Intervention<br>* Create respiratory illness action plan Weekly mHealth text messages Monthly study assessments Action planning and JIT coaching<br>|
| No Intervention: Active Control (AC)<br>AC subjects will receive usual comprehensive medical care and coordination. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Number of days to meet target enrollment of 90 participants | Feasibility will in part be measured by the number of days to meet target enrollment of 90 participants. | up to 3 months | 
| Feasibility: Number of days between randomization and intervention activities | Feasibility will in part be measured by the number of days between randomization and (time zero) intervention activities. | up to 3 months | 
| Feasibility: Number of minutes logged for action planning and coaching activities | Feasibility will in part be measured by the amount of time it takes to deliver the intervention. | up to 6 months | 
| Feasibility: Number of Intervention Triggers Per Patient | Feasibility will in part be measured by the number of intervention triggers per patient (annualized), including respiratory and non-respiratory. | up to 6 months | 
| Feasibility: Incidence of Data Infrastructure | Feasibility will in part be measured by the presence of necessary data infrastructure issues. This is a measure of the presence of complete data collection, between 2 sites, data use agreements and Institutional Review Board reliance. | up to 24 months | 
| Acceptability: Participant Enrollment Rate | Acceptability will in part be measured by the participant enrollment rate, or the number of participants enrolled divided by the number of participants approached. | up to 6 months | 
| Acceptability: Categorized Reasons for Consent Refusal | Acceptability will in part be assessed by collecting potential participants reason for not consenting to the study. Reasons will be summarized in tabular form. | up to 6 months | 
| Acceptability: Participant Drop Out Rate | Acceptability will in part be measured by the participant drop out rate. | up to 6 months | 
| Acceptability: Quantitative Participant Feedback Questions | Acceptability of the intervention will in part be measured by the participant feedback. Questions with binary Yes/No answers to be reported here include: 'Did you use the [action plan / coaching] this month?' and questions with binary 'Definitely/Probably' answers to the questions, 'How likely are you to recommend [action planning / texting and clinical response]to others?' and 'How much would you want these approaches to continue as a part of regular care after the study is done?'. | up to 6 months | 
| Acceptability: Qualitative Participant Feedback Questions | Acceptability of the intervention will in part be measured by the participant feedback to better understand barriers and benefits. Qualitative questions including 'how could any of [the intervention - action planning, texting, coaching] be improved?' and 'Why would you recommend (or not recommend) this intervention to another family?' Participant feedback will be summarized thematically. | up to 6 months | 
| Acceptability: System Usability Scale - composite score | Acceptability of the intervention will in part be measured by composite score. The System Usability Scale is a 10-item survey scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). | up to 6 months | 
| Fidelity: Time of Participant Enrollment in the Study | Fidelity of the intervention will in part be measured by the amount of time (in months) the participant was enrolled in the study. The target participation time is 6 months. | up to 6 months | 
| Fidelity: Number of Respiratory and Overall Action Plans Per Patient | Fidelity of the intervention will in part be measured by the number of respiratory and overall action plans per patient. The goal is greater than or equal to 1. | up to 6 months | 
| Fidelity: Coaching Visit Success Rate by Intervention Trigger | Fidelity of the intervention will in part be measured by the coaching visit success rate, which is the number of visits (at home or virtually) completed divided by the number of visits expected), stratified by trigger. The goal is over 80 percent. | up to 6 months | 
| Fidelity: Coaching Phone Call Success Rate by Intervention Trigger | Fidelity of the intervention will in part be measured by the coaching phone call success rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. | up to 6 months | 
| Fidelity: Text Message Response Rate | Fidelity of the intervention will in part be measured by the response rate to mHealth text messages, which is the number of texts responded divided by the number of texts expected). | up to 6 months | 
| Fidelity: Number of Participants Inappropriately Receiving Intervention | Fidelity of the intervention will in part be measured by cross-over, which is the number of participants inappropriately receiving the intervention component. | up to 6 months | 
| Fidelity: Data Collection Rate | Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Respiratory Diagnosis Requiring Hospitalization | Severe respiratory illness, defined as respiratory diagnoses requiring hospitalization. Respiratory diagnoses includes discharge diagnosis of any of the following: asthma, pneumonia (community or hospital acquired), bronchiolitis, influenza, upper or lower respiratory tract infection, tracheitis, aspiration pneumonia/pneumonitis, chronic lung disease, respiratory failure. | up to 6 months | 
| Total Hospital Days During Severe Respiratory Illness |  | up to 6 months | 
| Number of Systemic Steroid Courses |  | up to 6 months | 
| Number of Systemic Antibiotic Courses |  | up to 6 months | 
| Number of Respiratory Emergency Department Visits |  | up to 6 months | 
| Child Mortality Rate |  | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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support, caregiver