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

Not Applicable

Completed

Conditions: Cerebral Palsy

Interventions: Behavioral: RE-PACT Intervention

Registration Number: NCT05292365

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: 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: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RE-PACT Intervention	RE-PACT Intervention	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.

Primary Outcome Measures

Name	Time	Method
Feasibility: Number of Days to Meet Target Enrollment Size	up to 3 months	Feasibility will, in part, be measured by the number of days to meet target enrollment by wave. There are a total of 3 recruitment waves. This Outcome Measure was assessed by child.
Feasibility: Median Number of Days Between Randomization and Intervention Activities	up to 3 months	Feasibility will, in part, be measured by the number of days between randomization and (time zero) intervention activities. This Outcome Measure was assessed by child.
Feasibility: Mean Number of Minutes Logged for Action Planning	up to 6 months	Feasibility will, in part, be measured by the amount of time it takes to deliver the intervention. This Outcome Measure was assessed by child.
Feasibility: Mean Number of Minutes Logged for Clinical Response / Coaching	up to 6 months	Feasibility will, in part, be measured by the amount of time it takes to deliver the intervention. This Outcome Measure was assessed by child.
Feasibility: Mean Number of Intervention Triggers Per Patient	up to 6 months	Feasibility will, in part, be measured by the number of intervention triggers per patient (annualized), including respiratory and non-respiratory triggers. This Outcome Measure was assessed by child.
Feasibility: Incidence of Data Infrastructure Issues	up to 22 months	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. This outcome includes any events that occur over the study duration.
Acceptability: Participant Enrollment Rate	up to 6 months	Acceptability will in part be measured by the participant enrollment rate, or the number of participants enrolled divided by the number of participants approached + potentially eligible. This Outcome Measure was assessed by child.
Acceptability: Categorized Reasons for Consent Refusal	up to 6 months	Acceptability will in part be assessed by collecting potential participants reason for not consenting to the study. Reasons will be summarized in tabular form. This Outcome Measure was assessed in caregivers.
Acceptability: Participant Drop Out Rate	up to 6 months	Acceptability will in part be measured by the participant drop out rate. This Outcome Measure was assessed by child.
Acceptability: Measured by Mean Number of Months Participants Reported Using Action Plan	up to 6 months	Acceptability of the intervention will in part be measured by the participant feedback. - The number of months, on average, where participants reported use of an action plan. This Outcome Measure was assessed by dyad.
Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others	up to 6 months	Acceptability of the intervention will in part be measured by the participant feedback. - Number of participants reporting definite or probably recommendation of action planning to others. This Outcome Measure was assessed by dyad.
Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others	up to 6 months	Acceptability of the intervention will in part be measured by the participant feedback. - Number of participants reporting definite or probably recommendation of texting and clinical response to others. This Outcome Measure was assessed in dyads.
Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done	up to 6 months	Acceptability of the intervention will in part be measured by the participant feedback. - 'How much would you want these approaches to continue as a part of regular care after the study is done?'. This Outcome Measure was assessed in dyads.
Acceptability: System Usability Scale - Composite Score	up to 6 months	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). Higher scores indicate higher usability. Score range = 0 - 100. This Outcome Measure was assessed in dyads. To calculate the score: Step 1: Convert the scale into number for each of the 10 questions Strongly Disagree: 1 point Disagree: 2 points Neutral: 3 points Agree: 4 points Strongly Agree: 5 points Step 2: Calculate X = Sum of the points for all odd-numbered questions - 5 Y = 25 - Sum of the points for all even-numbered questions SUS Score = (X + Y) x 2.5
Fidelity: Time of Participant Enrollment in the Study	up to 6 months	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. This Outcome Measure was assessed in children.
Fidelity: Number of Respiratory Action Plans Per Patient	up to 6 months	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. This Outcome Measure was assessed in children.
Fidelity: Number of Overall Action Plans Per Patient	up to 6 months	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. This Outcome Measure was assessed in children.
Fidelity: Coaching Visit Success Rate by Intervention Trigger	up to 6 months	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. This Outcome Measure was assessed in children.
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5	up to 6 months	Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children.
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge	up to 6 months	Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children.
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team	up to 6 months	Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children.
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers	up to 6 months	Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children.
Fidelity: Text Message Response Rate	up to 6 months	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. This Outcome Measure was assessed in dyads.
Fidelity: Number of Participants Inappropriately Receiving Intervention	up to 6 months	Fidelity of the intervention will in part be measured by cross-over, which is the number of participants inappropriately receiving the intervention component. This Outcome Measure was assessed in children.
Fidelity: Data Collection Rate: Enrollment Surveys	Baseline to 2 months	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. This Outcome Measure was assessed in dyads.
Fidelity: Data Collection Rate: Monthly Surveys	up to 6 months	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. This Outcome Measure was assessed in dyads.
Fidelity: Data Collection Rate: Exit Surveys	up to 6 months	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. This Outcome Measure was assessed in dyads.

Secondary Outcome Measures

Name	Time	Method
Total Hospital Days During Severe Respiratory Illness by Arm	up to 6 months	Hospital days were summed by arm.
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
Incidence of Respiratory Diagnosis Requiring Hospitalization	up to 6 months	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. - Number of children with at least 1 severe respiratory illness