Clinical trial NCT05292365: Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe CP
Official title: Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe Cerebral Palsy (CP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: caregiver
support
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: eligible caregiver/child dyads are randomized to intervention or active control
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Number of Days to Meet Target Enrollment Size
timeFrame: up to 3 months
measure: Feasibility: Median Number of Days Between Randomization and Intervention Activities
timeFrame: up to 3 months
measure: Feasibility: Mean Number of Minutes Logged for Action Planning
timeFrame: up to 6 months
measure: Feasibility: Mean Number of Minutes Logged for Clinical Response / Coaching
timeFrame: up to 6 months
measure: Feasibility: Mean Number of Intervention Triggers Per Patient
timeFrame: up to 6 months
measure: Feasibility: Incidence of Data Infrastructure Issues
timeFrame: up to 22 months
measure: Acceptability: Participant Enrollment Rate
timeFrame: up to 6 months
measure: Acceptability: Categorized Reasons for Consent Refusal
timeFrame: up to 6 months
measure: Acceptability: Participant Drop Out Rate
timeFrame: up to 6 months
measure: Acceptability: Measured by Mean Number of Months Participants Reported Using Action Plan
timeFrame: up to 6 months
measure: Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others
timeFrame: up to 6 months
measure: Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others
timeFrame: up to 6 months
measure: Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done
timeFrame: up to 6 months
measure: Acceptability: System Usability Scale - Composite Score
timeFrame: up to 6 months
measure: Fidelity: Time of Participant Enrollment in the Study
timeFrame: up to 6 months
measure: Fidelity: Number of Respiratory Action Plans Per Patient
timeFrame: up to 6 months
measure: Fidelity: Number of Overall Action Plans Per Patient
timeFrame: up to 6 months
measure: Fidelity: Coaching Visit Success Rate by Intervention Trigger
timeFrame: up to 6 months
measure: Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5
timeFrame: up to 6 months
measure: Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge
timeFrame: up to 6 months
measure: Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team
timeFrame: up to 6 months
measure: Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers
timeFrame: up to 6 months
measure: Fidelity: Text Message Response Rate
timeFrame: up to 6 months
measure: Fidelity: Number of Participants Inappropriately Receiving Intervention
timeFrame: up to 6 months
measure: Fidelity: Data Collection Rate: Enrollment Surveys
timeFrame: Baseline to 2 months
measure: Fidelity: Data Collection Rate: Monthly Surveys
timeFrame: up to 6 months
measure: Fidelity: Data Collection Rate: Exit Surveys
timeFrame: up to 6 months
Secondary outcomes:
measure: Incidence of Respiratory Diagnosis Requiring Hospitalization
timeFrame: up to 6 months
measure: Total Hospital Days During Severe Respiratory Illness by Arm
timeFrame: up to 6 months
measure: Number of Systemic Steroid Courses
timeFrame: up to 6 months
measure: Number of Systemic Antibiotic Courses
timeFrame: up to 6 months
measure: Number of Respiratory Emergency Department Visits
timeFrame: up to 6 months
measure: Child Mortality Rate
timeFrame: up to 6 months
Other outcomes:
measure: Family Caregiver Activation in Transition Measure (FCAT) - Mean Composite Score
timeFrame: up to 6 months
measure: Caregiver General Self-Efficacy Scale (GSES) - Sum Composite Score
timeFrame: up to 6 months
measure: Family Experiences With Care Coordination (FECC): Care Coordination Question Set
timeFrame: up to 6 months
measure: Average Confidence Responses Reported by mHealth Texting
timeFrame: up to 6 months
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Ryan Coller, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: