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.

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).

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.

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

Feasibility will in part be measured by the number of days to meet target enrollment of 90 participants.

Feasibility will in part be measured by the number of days between randomization and (time zero) intervention activities.

Feasibility will in part be measured by the number of intervention triggers per patient (annualized), including respiratory and non-respiratory.

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.

Acceptability will in part be measured by the participant enrollment rate, or the number of participants enrolled divided by the number of participants approached.

Acceptability will in part be assessed by collecting potential participants reason for not consenting to the study. Reasons will be summarized in tabular form.

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?'.

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.

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).

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.

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.

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.

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.

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).

Fidelity of the intervention will in part be measured by cross-over, which is the number of participants inappropriately receiving the intervention component.

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.

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.

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).

Capability is in part measured by the GSES mean 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).

Motivation is assessed by the confidence response to weekly texting (1-10 with higher scores indicating increased confidence).

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

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.

Data from this study may be requested from other researchers after the completion of the primary endpoint analyses by contacting the study PI.

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.