Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe CP (RE-PACT)

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: RE-PACT Intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: RE-PACT Intervention; Create respiratory illness action plan; Weekly mHealth text messages; Monthly study assessments; Action planning and JIT coaching
No Intervention: Active Control (AC); AC subjects will receive usual comprehensive medical care and coordination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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.	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.	up to 6 months
Fidelity: Number of 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. This Outcome Measure was assessed in children.	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.	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.	up to 6 months
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge	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.	up to 6 months
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team	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.	up to 6 months
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers	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.	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.	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.	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.	Baseline to 2 months
Fidelity: Data Collection Rate: Monthly 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.	up to 6 months
Fidelity: Data Collection Rate: Exit 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.	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	up to 6 months
Total Hospital Days During Severe Respiratory Illness by Arm	Hospital days were summed by arm.	up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Caregiver Activation in Transition Measure (FCAT) - Mean Composite Score	Capability is in part measured by the FCAT mean composite score,. FCAT is a 10-item survey to assess the caregiver's challenges on the day it is taken, scored on a 5 point likert scale from 1 (disagree strongly) to 5 (agree strongly). The mean composite score ranges from 1 - 5 with higher scores indicating higher activation. Activation of a family member refers to their desire, knowledge, confidence, and skills that can inform engagement in healthcare.	up to 6 months
Caregiver General Self-Efficacy Scale (GSES) - Sum Composite Score	Capability is in part measured by the GSES sum composite score. GSES is a 10-item survey scored on a 4-point Likert scale from 1 (not true at all) to 4 (exactly true). The sum composite score ranges from 10 - 40, with higher scores indicating higher efficacy.	up to 6 months
Family Experiences With Care Coordination (FECC): Care Coordination Question Set	Opportunity is assessed via the FECC score, using measure specifications for each item(s). The Care Coordination Question set assesses the statement "Care Coordinator Was Knowledgeable, Supportive and Advocated for Child's Needs" on a scale from 0 - 100 with; 0 = "Care Coordinator Was NOT Knowledgeable, Supportive and Advocated for Child's Needs"; 100 = "Care Coordinator Was DEFINITELY Knowledgeable, Supportive and Advocated for Child's Needs." This Outcome Measure was assessed in dyads.	up to 6 months
Average Confidence Responses Reported by mHealth Texting	Motivation is assessed by the confidence response to weekly texting and averaged over time by participant. (1-10 with higher scores indicating increased confidence). This Outcome Measure was assessed in dyads.	up to 6 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Ryan Coller, MD, MPH, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Actual): February 27, 2024
• Study Completion (Actual): February 27, 2024

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: caregiver; support
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2021-1532; A536771 (Other Identifier: UW Madison); R34HL153570-01A1 (U.S. NIH Grant/Contract); Protocol Version 2/24/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Data prepared for distribution under a data-use agreement will be redacted to ensure privacy of study participant identity. The data-use agreement will include requirements to protect participants' privacy and data confidentiality. It will prohibit the recipient from transferring the data to other users and require that the data's security be protected by standard means and be used for research purposes only.

• IPD Sharing Time Frame: Data from this study may be requested from other researchers after the completion of the primary endpoint analyses by contacting the study PI.
• IPD Sharing Access Criteria: The method of distribution will be by request to the study PI. After review and approval, a requestor completes the data-sharing agreement, requestor will receive a limited dataset mailed by CD or emailed through UW-Madison secured email systems that require users to create an account and sign-in with a username and password in order to receive and download any type of sensitive data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No