Cerebral Palsy
Conditions
Keywords
caregiver, support
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).
Interventions
BEHAVIORALRE-PACT Intervention
* Create respiratory illness action plan * Weekly mHealth text messages * Monthly study assessments * Action planning and JIT coaching
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
eligible caregiver/child dyads are randomized to intervention or active control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Family Caregiver Activation in Transition Measure (FCAT) - Mean Composite Score | up to 6 months | 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. |
| Family Experiences With Care Coordination (FECC): Care Coordination Question Set | up to 6 months | 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. |
| Average Confidence Responses Reported by mHealth Texting | up to 6 months | 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. |
| Caregiver General Self-Efficacy Scale (GSES) - Sum Composite Score | up to 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RE-PACT Intervention: Child 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.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching | 36 |
| RE-PACT Intervention: Caregiver 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.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching | 35 |
| Active Control (AC): Child AC subjects will receive usual comprehensive medical care and coordination. | 24 |
| Active Control (AC): Caregiver AC subjects will receive usual comprehensive medical care and coordination. | 24 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Met Exclusion Criteria: Participant disenrolled from their complex care program | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | RE-PACT Intervention: Child | RE-PACT Intervention: Caregiver | Active Control (AC): Child | Active Control (AC): Caregiver | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 36 Participants | 0 Participants | 24 Participants | 0 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 35 Participants | 0 Participants | 24 Participants | 59 Participants |
| Age, Continuous Caregiver | — | 42 years | — | 37 years | 40 years |
| Age, Continuous Child | 11 years | — | 9 years | — | 10 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 12 Participants | 9 Participants | 7 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 21 Participants | 12 Participants | 15 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 3 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants | 5 Participants | 19 Participants |
| Race (NIH/OMB) White | 26 Participants | 25 Participants | 12 Participants | 15 Participants | 78 Participants |
| Region of Enrollment United States | 36 participants | 35 participants | 24 participants | 24 participants | 119 participants |
| Sex: Female, Male Female | 10 Participants | 32 Participants | 11 Participants | 22 Participants | 75 Participants |
| Sex: Female, Male Male | 26 Participants | 3 Participants | 11 Participants | 0 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 24 |
| other Total, other adverse events | 0 / 36 | 0 / 24 |
| serious Total, serious adverse events | 0 / 36 | 1 / 24 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Not interested in the intervention | 35 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Ineligible: Does not have Cerebral Palsy | 9 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Ineligible: Does not meet motor function criteria | 10 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Ineligible: Does not receive respiratory care | 16 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Ineligible: Not enrolled in a complex care program | 6 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Ineligible: Moving out of the area | 1 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Ineligible: Does not meet English or Spanish language proficiency | 2 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Recruitment completed before enrollment | 4 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Not interested in research | 5 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Too busy | 7 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Categorized Reasons for Consent Refusal | Unable to contact | 38 Participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Acceptability: Measured by Mean Number of Months Participants Reported Using Action Plan | 1.6 Months | Standard Deviation 1.6 |
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others | Probably or Definitely recommends action planning to others | 25 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others | Possibly, Probably not, or Definitely does not recommend action planning to others | 10 Participants |
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others | Probably or Definitely recommends testing and/or clinical response to others | 27 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others | Possibly, Probably not, or Definitely does not recommend testing and/or clinical response to others | 8 Participants |
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done | Probably or Definitely wants these approaches to continue as a part of regular care | 23 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done | Possibly, Probably not, or Definitely does not want approaches to continue as a part of regular care | 12 Participants |
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Acceptability: Participant Drop Out Rate | Completed Intervention | 35 Participants |
| RE-PACT Intervention + Active Control (AC) | Acceptability: Participant Drop Out Rate | Dropped-out | 1 Participants |
| Active Control (AC) | Acceptability: Participant Drop Out Rate | Completed Intervention | 24 Participants |
| Active Control (AC) | Acceptability: Participant Drop Out Rate | Dropped-out | 0 Participants |
Primary
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
Population: The number of participants analyzed must reflect the number of participants approached in addition to those consented. Enrollment rate was not stratified by arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Acceptability: Participant Enrollment Rate | 60 Participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Acceptability: System Usability Scale - Composite Score | 79.5 score on a scale | Standard Deviation 11.7 |
Primary
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.
Time frame: up to 22 months
Population: Number analyzed represents the number of participants by wave.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Feasibility: Incidence of Data Infrastructure Issues | Wave 1 | 0 Data Infrastructure Issues |
| RE-PACT Intervention + Active Control (AC) | Feasibility: Incidence of Data Infrastructure Issues | Wave 2 | 0 Data Infrastructure Issues |
| RE-PACT Intervention + Active Control (AC) | Feasibility: Incidence of Data Infrastructure Issues | Wave 3 | 0 Data Infrastructure Issues |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Feasibility: Mean Number of Intervention Triggers Per Patient | 0.7 Intervention Triggers | Standard Deviation 1 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Feasibility: Mean Number of Minutes Logged for Action Planning | 22.8 Minutes | Standard Deviation 10.9 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Feasibility: Mean Number of Minutes Logged for Clinical Response / Coaching | 86.8 Minutes | Standard Deviation 122.2 |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Feasibility: Median Number of Days Between Randomization and Intervention Activities | 4 Days |
Primary
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
Population: \*Recruitment duration was not stratified by arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Feasibility: Number of Days to Meet Target Enrollment Size | Wave 1 | 56 Days |
| RE-PACT Intervention + Active Control (AC) | Feasibility: Number of Days to Meet Target Enrollment Size | Wave 2 | 29 Days |
| RE-PACT Intervention + Active Control (AC) | Feasibility: Number of Days to Meet Target Enrollment Size | Wave 3 | 129 Days |
Primary
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.
Time frame: up to 6 months
Population: More follow-ups were completed than expected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team | Number completed | 9 Follow-Ups |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team | Number expected | 8 Follow-Ups |
Primary
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
Population: More follow-ups were completed than expected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5 | Number completed | 20 Follow-Ups |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5 | Number expected | 18 Follow-Ups |
Primary
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.
Time frame: up to 6 months
Population: More follow-ups were completed than expected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge | Number completed | 30 Follow-Ups |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge | Number expected | 18 Follow-Ups |
Primary
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.
Time frame: up to 6 months
Population: More follow-ups were completed than expected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers | Number completed | 10 Follow-Ups |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers | Number expected | 8 Follow-Ups |
Primary
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
Population: Rows are stratified by trigger type. There are 26 triggers total, of which n = 9 are due to caregiver confidence, n = 9 are due to hospital discharge, n = 4 are due to caregiver contact, and n = 4 are due to multiple triggers.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Visit Success Rate by Intervention Trigger | Trigger: Caregiver reported confidence < 5 | Clinical response completed for trigger | 9 Intervention triggers |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Visit Success Rate by Intervention Trigger | Trigger: Caregiver reported confidence < 5 | Clinical response NOT completed for trigger | 0 Intervention triggers |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Visit Success Rate by Intervention Trigger | Trigger: Hospital Discharge | Clinical response completed for trigger | 9 Intervention triggers |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Visit Success Rate by Intervention Trigger | Trigger: Hospital Discharge | Clinical response NOT completed for trigger | 0 Intervention triggers |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Visit Success Rate by Intervention Trigger | Trigger: Caregiver calls or messages complex care team | Clinical response completed for trigger | 4 Intervention triggers |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Visit Success Rate by Intervention Trigger | Trigger: Caregiver calls or messages complex care team | Clinical response NOT completed for trigger | 0 Intervention triggers |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Visit Success Rate by Intervention Trigger | Trigger: Multiple triggers | Clinical response completed for trigger | 4 Intervention triggers |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Coaching Visit Success Rate by Intervention Trigger | Trigger: Multiple triggers | Clinical response NOT completed for trigger | 0 Intervention triggers |
Primary
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
Population: \*Data collection was not stratified by arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Data Collection Rate: Enrollment Surveys | 59 Completed Enrollment Surveys |
Primary
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.
Time frame: up to 6 months
Population: \*Data collection was not stratified by arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Data Collection Rate: Exit Surveys | 55 Completed Exit Surveys |
Primary
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.
Time frame: up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Data Collection Rate: Monthly Surveys | 210 Completed Monthly Surveys |
Primary
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.
Time frame: up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Number of Overall Action Plans Per Patient | 1 Overall Action Plans | Standard Deviation 0 |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Number of Participants Inappropriately Receiving Intervention | 0 Participants |
| Active Control (AC) | Fidelity: Number of Participants Inappropriately Receiving Intervention | 0 Participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Number of Respiratory Action Plans Per Patient | 1 Respiratory Action Plans | Standard Deviation 0 |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Text Message Response Rate | Number completed | 867 Text messages |
| RE-PACT Intervention + Active Control (AC) | Fidelity: Text Message Response Rate | Number expected | 889 Text messages |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Fidelity: Time of Participant Enrollment in the Study | 5.9 Months | Standard Deviation 0.5 |
| Active Control (AC) | Fidelity: Time of Participant Enrollment in the Study | 6 Months | Standard Deviation 0 |
Secondary
Child Mortality Rate
Time frame: up to 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Child Mortality Rate | Child death | 0 Participants |
| RE-PACT Intervention + Active Control (AC) | Child Mortality Rate | No child death | 26 Participants |
| Active Control (AC) | Child Mortality Rate | Child death | 0 Participants |
| Active Control (AC) | Child Mortality Rate | No child death | 24 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Incidence of Respiratory Diagnosis Requiring Hospitalization | Children with at least one severe respiratory illness | 8 Participants |
| RE-PACT Intervention + Active Control (AC) | Incidence of Respiratory Diagnosis Requiring Hospitalization | Children with no severe respiratory illness | 18 Participants |
| Active Control (AC) | Incidence of Respiratory Diagnosis Requiring Hospitalization | Children with at least one severe respiratory illness | 11 Participants |
| Active Control (AC) | Incidence of Respiratory Diagnosis Requiring Hospitalization | Children with no severe respiratory illness | 13 Participants |
Secondary
Number of Respiratory Emergency Department Visits
Time frame: up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Number of Respiratory Emergency Department Visits | 0 Respiratory ED Visits |
| Active Control (AC) | Number of Respiratory Emergency Department Visits | 3 Respiratory ED Visits |
Secondary
Number of Systemic Antibiotic Courses
Time frame: up to 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Number of Systemic Antibiotic Courses | Children with at least one systemic antibiotic course throughout the study time frame | 5 Participants |
| RE-PACT Intervention + Active Control (AC) | Number of Systemic Antibiotic Courses | Children with no systemic antibiotic course throughout the study time frame | 21 Participants |
| Active Control (AC) | Number of Systemic Antibiotic Courses | Children with at least one systemic antibiotic course throughout the study time frame | 6 Participants |
| Active Control (AC) | Number of Systemic Antibiotic Courses | Children with no systemic antibiotic course throughout the study time frame | 18 Participants |
Secondary
Number of Systemic Steroid Courses
Time frame: up to 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Number of Systemic Steroid Courses | Children with at least one systemic steroid course | 3 Participants |
| RE-PACT Intervention + Active Control (AC) | Number of Systemic Steroid Courses | Children with no systemic steroid course | 23 Participants |
| Active Control (AC) | Number of Systemic Steroid Courses | Children with at least one systemic steroid course | 3 Participants |
| Active Control (AC) | Number of Systemic Steroid Courses | Children with no systemic steroid course | 21 Participants |
Secondary
Total Hospital Days During Severe Respiratory Illness by Arm
Hospital days were summed by arm.
Time frame: up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Total Hospital Days During Severe Respiratory Illness by Arm | 8 Hospital Days |
| Active Control (AC) | Total Hospital Days During Severe Respiratory Illness by Arm | 32 Hospital Days |
Other Pre-specified
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.
Time frame: up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Average Confidence Responses Reported by mHealth Texting | 8.59 score on a scale | Standard Deviation 1.62 |
Other Pre-specified
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.
Time frame: up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Caregiver General Self-Efficacy Scale (GSES) - Sum Composite Score | 34.2 score on a scale | Standard Deviation 4.4 |
| Active Control (AC) | Caregiver General Self-Efficacy Scale (GSES) - Sum Composite Score | 35.3 score on a scale | Standard Deviation 4.2 |
Other Pre-specified
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.
Time frame: up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Family Caregiver Activation in Transition Measure (FCAT) - Mean Composite Score | 4.5 score on a scale | Standard Deviation 0.4 |
| Active Control (AC) | Family Caregiver Activation in Transition Measure (FCAT) - Mean Composite Score | 4.5 score on a scale | Standard Deviation 0.4 |
Other Pre-specified
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.
Time frame: up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RE-PACT Intervention + Active Control (AC) | Family Experiences With Care Coordination (FECC): Care Coordination Question Set | 87.3 score on a scale | Standard Deviation 19.1 |
| Active Control (AC) | Family Experiences With Care Coordination (FECC): Care Coordination Question Set | 94.2 score on a scale | Standard Deviation 8.2 |