Trial Outcomes & Findings for Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (NCT NCT02319967)

NCT ID: NCT02319967

Last Updated: 2019-06-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 373 participants
• Primary outcome timeframe: Baseline and 6 months after index ED discharge
• Results posted on: 2019-06-19

Participant Flow

Participant milestones

Measure	Enhanced Usual Care Inhaler technique education and distribution of spacers to all participants.	ED-only Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Overall Study STARTED	126	126	121
Overall Study COMPLETED	78	82	76
Overall Study NOT COMPLETED	48	44	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes

Baseline characteristics by cohort

Measure	Enhanced Usual Care n=126 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=126 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=121 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.	Total n=373 Participants Total of all reporting groups
Age, Continuous	7.3 years STANDARD_DEVIATION 1.9 • n=5 Participants	7.4 years STANDARD_DEVIATION 2.0 • n=7 Participants	7.3 years STANDARD_DEVIATION 1.9 • n=5 Participants	7.4 years STANDARD_DEVIATION 1.9 • n=4 Participants
Age, Customized Age, Categorial · 5-7 years	72 Participants n=5 Participants	75 Participants n=7 Participants	70 Participants n=5 Participants	217 Participants n=4 Participants
Age, Customized Age, Categorial · 8-11 years	54 Participants n=5 Participants	51 Participants n=7 Participants	51 Participants n=5 Participants	156 Participants n=4 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	35 Participants n=7 Participants	42 Participants n=5 Participants	124 Participants n=4 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	91 Participants n=7 Participants	79 Participants n=5 Participants	249 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=5 Participants	37 Participants n=7 Participants	41 Participants n=5 Participants	116 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants	87 Participants n=7 Participants	80 Participants n=5 Participants	254 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	81 Participants n=5 Participants	81 Participants n=7 Participants	77 Participants n=5 Participants	239 Participants n=4 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	38 Participants n=7 Participants	38 Participants n=5 Participants	115 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months after index ED discharge

Population: The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.

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.

Outcome measures

Measure	Enhanced Usual Care n=78 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=82 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=76 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
PROMIS Asthma Impact Scale (v1.0, SF8a)	-7.8 T-score Interval -17.3 to 0.0	-9.3 T-score Interval -16.4 to -5.0	-11.9 T-score Interval -19.3 to -6.0

PRIMARY outcome

Timeframe: Baseline and 6 months after index ED discharge

Population: The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.

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.

Outcome measures

Measure	Enhanced Usual Care n=76 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=82 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=75 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)	0.0 T-score Interval -6.0 to 6.1	0.0 T-score Interval -3.5 to 9.7	0.0 T-score Interval -4.3 to 6.8

SECONDARY outcome

Timeframe: Baseline and 6 months after index ED discharge

Population: The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.

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.

Outcome measures

Measure	Enhanced Usual Care n=33 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=34 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=24 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Childhood Asthma Control Test (cACT)	3.0 score Interval 1.0 to 6.0	4.0 score Interval 1.2 to 5.8	5.5 score Interval 3.0 to 7.2

SECONDARY outcome

Timeframe: Baseline and 6 months after index ED discharge

Population: The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.

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.

Outcome measures

Measure	Enhanced Usual Care n=66 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=80 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=67 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
PROMIS Anxiety (v1.0, SF4a)	-3.2 T-score Interval -10.9 to 0.0	-3.8 T-score Interval -11.2 to 0.0	-2.5 T-score Interval -13.4 to 1.9

SECONDARY outcome

Timeframe: Baseline and 6 months after index ED discharge

Population: The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.

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.

Outcome measures

Measure	Enhanced Usual Care n=67 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=79 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=68 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
PROMIS Depression (v1.0, SF4a)	0.0 T-score Interval -2.2 to 0.0	0.0 T-score Interval -4.9 to 0.0	0.0 T-score Interval -7.3 to 0.0

SECONDARY outcome

Timeframe: Baseline and 6 months after index ED discharge

Population: The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.

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.

Outcome measures

Measure	Enhanced Usual Care n=64 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=79 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=67 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
PROMIS Fatigue (v1.0, SF4a)	0.0 T-score Interval -9.4 to 8.2	0.0 T-score Interval -8.5 to 4.4	-2.6 T-score Interval -12.2 to 1.4

SECONDARY outcome

Timeframe: Baseline and 6 months after index ED discharge

Population: The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.

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.

Outcome measures

Measure	Enhanced Usual Care n=64 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=77 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=65 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
PROMIS Sleep Disturbance (v1.0, SF4a)	0.0 T-score Interval -4.1 to 4.0	0.0 T-score Interval -3.7 to 2.4	-1.9 T-score Interval -4.0 to 2.4

SECONDARY outcome

Timeframe: Baseline and 6 months after index ED discharge

Population: The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.

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.

Outcome measures

Measure	Enhanced Usual Care n=63 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=74 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=64 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)	0.8 score Interval 0.0 to 2.1	1.1 score Interval 0.1 to 2.2	1.2 score Interval 0.2 to 2.2

SECONDARY outcome

Timeframe: 6 months post index ED discharge

Count of participants (children) with at least one all-cause ED or urgent care visit at 6 months

Outcome measures

Measure	Enhanced Usual Care n=126 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=126 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=121 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits	54 Participants	53 Participants	44 Participants

SECONDARY outcome

Timeframe: 6 months post index ED discharge

Count of participants (children) with at least one all-cause hospitalization at 6 months

Outcome measures

Measure	Enhanced Usual Care n=126 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=126 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=121 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Number of Participants With All-cause Hospitalizations	12 Participants	11 Participants	9 Participants

SECONDARY outcome

Timeframe: 7 days post index ED discharge

Count of participants who filled a prescription for systemic corticosteroids within 7 days of discharge

Outcome measures

Measure	Enhanced Usual Care n=100 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=108 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=97 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids	82 Participants	89 Participants	79 Participants

SECONDARY outcome

Timeframe: 7 days post index ED discharge

Count of participants who filled prescription for inhaled corticosteroids or other controller within 7 days of discharge

Outcome measures

Measure	Enhanced Usual Care n=100 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=108 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=97 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller	42 Participants	49 Participants	69 Participants

SECONDARY outcome

Timeframe: 4 weeks post index ED discharge

Count of participants who attended follow-up appointment with patient-identifier asthma provider within 4 weeks of discharge

Outcome measures

Measure	Enhanced Usual Care n=115 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=114 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=111 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider	37 Participants	48 Participants	57 Participants

SECONDARY outcome

Timeframe: At index ED discharge

Count of participants who were provided documented discharge instructions to use systemic corticosteroids

Outcome measures

Measure	Enhanced Usual Care n=126 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=126 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=121 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids	77 Participants	125 Participants	118 Participants

SECONDARY outcome

Timeframe: At index ED discharge

Count of participants who were provided documented discharge instructions to use inhaled corticosteroids or other controller

Outcome measures

Measure	Enhanced Usual Care n=126 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=126 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=121 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller	52 Participants	80 Participants	87 Participants

SECONDARY outcome

Timeframe: At index ED discharge

Count of participants who were provided documented discharge instructions to use an inhaled rescue medication

Outcome measures

Measure	Enhanced Usual Care n=126 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=126 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=121 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication	107 Participants	125 Participants	118 Participants

SECONDARY outcome

Timeframe: At index ED discharge

Count of participants who were provided documented discharge instructions for a follow-up appointment scheduled within 4 weeks of discharge

Outcome measures

Measure	Enhanced Usual Care n=126 Participants Inhaler technique education and distribution of spacers to all participants.	ED-only n=126 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge.	ED-plus-home n=121 Participants Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Community-health worker-led home visits. CAPE: Structured patient-centered ED discharge template completed prior to ED discharge. Home: Home visits led by community-health workers to reinforce CAPE and guide environmental remediation.
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff	10 Participants	62 Participants	56 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CAPE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CAPE + Home

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jerry A. Krishnan, MD, PhD

University of Illinois at Chicago

Phone: 312-413-3291

Email: chicagotrial@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place