Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: CAPE; Behavioral: CHW home visits

• Registration Number: NCT02319967
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

Chicago is an epicenter for asthma health disparities in the U.S., with African-American children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of these disparities is the high rate of visits to the Emergency Department (ED) for uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of guideline recommendations for ED discharge and strategies to reduce environmental triggers at home contribute to practice variation and poor adherence to guidelines. The CHICAGO Plan tests both ED- and home-level interventions to improve clinically meaningful outcomes in a minority pediatric ED population with uncontrolled asthma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-19
• Study Start: 2015-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Results First Submitted: 2017-12-22
• Results First Submitted QC: 2019-01-23
• Results First Posted: 2019-04-22
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ED-only	CAPE	Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.
ED-plus-home	CHW home visits	Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Home visits by a community health worker (CHW).
ED-plus-home	CAPE	Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Home visits by a community health worker (CHW).

Primary Outcome Measures

Name	Time	Method
PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)	Baseline and 6 months after index ED discharge	Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less satisfaction among caregivers; high scores indicate more satisfaction among caregivers.; PROMIS Satisfaction With Participation in Social Roles: Min possible T-score: 29.0; Max possible T-score: 64.1 Possible range for change in T-score is \[-35.1 to 35.1\]; The reported value represents a change in T-score from baseline to 6 months after index ED discharge.; A negative change in score indicates less satisfaction among caregivers. A positive change in score indicates a more satisfaction among caregivers. A score of 0 indicates no change.
PROMIS Asthma Impact Scale (v1.0, SF8a)	Baseline and 6 months after index ED discharge	Raw scores (0-32) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate better asthma; high scores indicate worse asthma.; PROMIS Asthma Impact Scale, Pediatric: Min possible T-score: 31.5; Max possible T-score: 76.2 Possible range for change in T-score is \[-44.7 to 44.7\]; PROMIS Asthma Impact Scale, Parent proxy: Min possible T-score: 32; Max possible T-score: 80 Possible range for change in T-score is \[-48 to 48\]; The reported value represents a change in T-score from baseline to 6 months after index ED discharge.; A negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.

Secondary Outcome Measures

Name	Time	Method
Childhood Asthma Control Test (cACT)	Baseline and 6 months after index ED discharge	The scores of each item were summed for a total score (0-27) to measure change from index to 6-month primary endpoint. Low scores indicate worse asthma; high scores indicate better asthma.; Childhood Asthma Control Test (cACT): Min possible score: 0; Max possible score: 27 Possible range for change in score is \[-27 to 27\]; The reported value represents a change in score from baseline to 6 months after index ED discharge.; A negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.
PROMIS Sleep Disturbance (v1.0, SF4a)	Baseline and 6 months after index ED discharge	Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less sleep disturbance; high scores indicate more sleep disturbance.; PROMIS Sleep Disturbance (v1.0, SF4a): Min possible T-score: 32.0; Max possible T-score: 73.3 Possible range for change in T-score is \[-41.3 to 41.3\]; The reported value represents a change in T-score from baseline to 6 months after index ED discharge.; A negative change in score indicates improvement in sleep disturbance (i.e., less sleep disturbance). A positive change in score indicates worsening of sleep disturbance (i.e., more sleep disturbance). A score of 0 indicates no change.
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)	Baseline and 6 months after index ED discharge	The overall score is the mean score across all 13 items. Each item is scored on a 7-point Likert scale with 1 indicating severe impairment and 7 indicating no impairment. Higher scores indicate better quality of life; lower scores indicate worse quality of life.; Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ): Min possible score: 1; Max possible score: 7 Possible range for change in score is \[-6 to 6\]; The reported value represents a change in overall score from baseline to 6 months after index ED discharge.; A negative change in score indicates worsening quality of life. A positive change in score indicates improvement in quality of life. A score of 0 indicates no change.
PROMIS Anxiety (v1.0, SF4a)	Baseline and 6 months after index ED discharge	Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less anxiety; high scores indicate more anxiety.; PROMIS Anxiety: Min possible T-score: 40.3; Max possible T-score: 81.6 Possible range for change in T-score is \[-41.3 to 41.3\]; The reported value represents a change in T-score from baseline to 6 months after index ED discharge.; A negative change in score indicates improvement in anxiety. A positive change in score indicates worsening of anxiety. A score of 0 indicates no change.
PROMIS Fatigue (v1.0, SF4a)	Baseline and 6 months after index ED discharge	Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less fatigue; high scores indicate more fatigue.; PROMIS Fatigue: Min possible T-score: 33.7; Max possible T-score: 75.8 Possible range for change in T-score is \[-42.1 to 42.1\]; The reported value represents a change in T-score from baseline to 6 months after index ED discharge.; A negative change in score indicates improvement in fatigue (i.e., less fatigue). A positive change in score indicates worsening of fatigue (i.e., more fatigue). A score of 0 indicates no change.
PROMIS Depression (v1.0, SF4a)	Baseline and 6 months after index ED discharge	Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less depression; high scores indicate more depression.; PROMIS Depression: Min possible T-score: 41.0; Max possible T-score: 79.4 Possible range for change in T-score is \[-38.4 to 38.4\]; The reported value represents a change in T-score from baseline to 6 months after index ED discharge.; A negative change in score indicates improvement in depression. A positive change in score indicates worsening of depression. A score of 0 indicates no change.
Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits	6 months post index ED discharge	Count of participants (children) with at least one all-cause ED or urgent care visit at 6 months
Number of Participants With All-cause Hospitalizations	6 months post index ED discharge	Count of participants (children) with at least one all-cause hospitalization at 6 months
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids	7 days post index ED discharge	Count of participants who filled a prescription for systemic corticosteroids within 7 days of discharge
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller	7 days post index ED discharge	Count of participants who filled prescription for inhaled corticosteroids or other controller within 7 days of discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids	At index ED discharge	Count of participants who were provided documented discharge instructions to use systemic corticosteroids
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication	At index ED discharge	Count of participants who were provided documented discharge instructions to use an inhaled rescue medication
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff	At index ED discharge	Count of participants who were provided documented discharge instructions for a follow-up appointment scheduled within 4 weeks of discharge
Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider	4 weeks post index ED discharge	Count of participants who attended follow-up appointment with patient-identifier asthma provider within 4 weeks of discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller	At index ED discharge	Count of participants who were provided documented discharge instructions to use inhaled corticosteroids or other controller

Trial Locations

Locations (6)

Cook County Health & Hospitals System; 🇺🇸 Chicago, Illinois, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Sinai Health System; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States