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

University of Wisconsin, Madison60 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Conditions

Cerebral Palsy

Interventions

RE-PACT InterventionBEHAVIORAL

* Create respiratory illness action plan * Weekly mHealth text messages * Monthly study assessments * Action planning and JIT coaching

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of California

Los Angeles, California, United States

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Feasibility: Number of Days to Meet Target Enrollment Size

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.

Time frame: up to 3 months

Feasibility: Median 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. This Outcome Measure was assessed by child.

Time frame: up to 3 months

Feasibility: Mean Number of Minutes Logged for Action Planning

Feasibility will, in part, be measured by the amount of time it takes to deliver the intervention. This Outcome Measure was assessed by child.

Time frame: up to 6 months

Feasibility: Mean Number of Minutes Logged for Clinical Response / Coaching

Feasibility will, in part, be measured by the amount of time it takes to deliver the intervention. This Outcome Measure was assessed by child.

Time frame: up to 6 months

Feasibility: Mean 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 triggers. This Outcome Measure was assessed by child.

Time frame: up to 6 months

Feasibility: Incidence of Data Infrastructure Issues

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: up to 22 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 + potentially eligible. This Outcome Measure was assessed by child.

Time frame: 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. This Outcome Measure was assessed in caregivers.

Time frame: up to 6 months

Acceptability: Participant Drop Out Rate

Acceptability will in part be measured by the participant drop out rate. This Outcome Measure was assessed by child.

Time frame: up to 6 months

Acceptability: Measured by Mean Number of Months Participants Reported Using Action Plan

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.

Time frame: up to 6 months

Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others

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.

Time frame: up to 6 months

Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others

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.

Time frame: up to 6 months

Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done

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.

Time frame: 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). 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

Time frame: 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. This Outcome Measure was assessed in children.

Time frame: up to 6 months

Fidelity: Number of Respiratory 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. This Outcome Measure was assessed in children.

Time frame: up to 6 months

Fidelity: Number of Overall Action Plans Per Patient

Time frame: 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. This Outcome Measure was assessed in children.

Time frame: up to 6 months

Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5

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.

Time frame: up to 6 months

Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge

Time frame: up to 6 months

Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team

Time frame: up to 6 months

Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers

Time frame: 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. This Outcome Measure was assessed in dyads.

Time frame: 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. This Outcome Measure was assessed in children.

Time frame: up to 6 months

Fidelity: Data Collection Rate: Enrollment Surveys

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.

Time frame: Baseline to 2 months

Fidelity: Data Collection Rate: Monthly Surveys

Time frame: up to 6 months

Fidelity: Data Collection Rate: Exit Surveys

Time frame: up to 6 months

Secondary Outcomes

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. \- Number of children with at least 1 severe respiratory illness

Time frame: up to 6 months

Total Hospital Days During Severe Respiratory Illness by Arm

Hospital days were summed by arm.

Time frame: up to 6 months

Number of Systemic Steroid Courses

Time frame: up to 6 months

Number of Systemic Antibiotic Courses

Time frame: up to 6 months

Number of Respiratory Emergency Department Visits

Time frame: up to 6 months

Child Mortality Rate

Time frame: up to 6 months