Asthma
Conditions
Keywords
community health worker, emergency, asthma
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.
Interventions
BEHAVIORALCAPE
Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers
BEHAVIORALCHW home visits
Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.
Sponsors
Sinai Health System
Cook County Health & Hospitals System
Rush University Medical Center
Ann & Robert H Lurie Children's Hospital of Chicago
University of Chicago
Chicago Department of Public Health
Respiratory Health Association
Chicago Asthma Consortium
Illinois Institute of Technology
Illinois Emergency Department Asthma Surveillance Project
Patient-Centered Outcomes Research Institute
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
(all of the following): 1. Child is 5-11 years of age (a population in whom a diagnosis of asthma is generally reliable, and in whom exacerbations are common); 2. Child is presenting to the ED, urgent care center, or observation unit at a participating clinical center (Anne and Robert H. Lurie Children's Hospital of Chicago, Sinai Health System's Mount Sinai Hospital, John H. Stroger Jr. Hospital of Cook County Health & Hospitals System, Rush University Medical Center, University of Chicago Medicine Comer Children's Hospital, and the University of Illinois Hospital & Health Sciences System); 3. Child is treated with at least 1 dose of an inhaled or nebulized short-acting bronchodilator (quick-relief medication); 4. Child received systemic corticosteroids in the ED OR the caregiver reported at least 1 additional acute care visit for asthma in the previous 6 months (defined as an asthma-related ED visit or urgent care visit, or course of systemic corticosteroids); 5. Child and caregiver approached at least 1 hour after receipt of the first dose of quick-relief medication or systemic corticosteroids, whichever occurred first; 6. Diagnosis of asthma exacerbation by treating clinician; 7. Treating ED clinician indicates the child is likely to be discharged to home; and 8. Caregiver reports that English or Spanish is the preferred language at home.
Exclusion criteria
(none of the following): 1. Caregiver declines to provide informed consent, or the child declines to provide assent; 2. Child is admitted to an intensive care unit or transferred to another healthcare facility; 3. Child or another member of the child's primary household is a current or previous participant in the CHICAGO Plan; 4. Child is enrolled in another study involving a health-related intervention; 5. A CHW is already visiting the home as part of another program; 6. Child does not reside in Chicago.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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 |
| 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. |
| 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 |
| 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 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 Corticosteroids or Other Controller | At index ED discharge | Count of participants who were provided documented discharge instructions to use inhaled corticosteroids or other controller |
| 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 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Usual Care Inhaler technique education and distribution of spacers to all participants. | 126 |
| 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. | 126 |
| 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. | 121 |
| Total | 373 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | ED-only | ED-plus-home | Total |
|---|---|---|---|---|
| Age, Continuous | 7.3 years STANDARD_DEVIATION 1.9 | 7.4 years STANDARD_DEVIATION 2 | 7.3 years STANDARD_DEVIATION 1.9 | 7.4 years STANDARD_DEVIATION 1.9 |
| Age, Customized Age, Categorial 5-7 years | 72 Participants | 75 Participants | 70 Participants | 217 Participants |
| Age, Customized Age, Categorial 8-11 years | 54 Participants | 51 Participants | 51 Participants | 156 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 37 Participants | 41 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants | 87 Participants | 80 Participants | 254 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 81 Participants | 81 Participants | 77 Participants | 239 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 7 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 38 Participants | 38 Participants | 115 Participants |
| Sex: Female, Male Female | 47 Participants | 35 Participants | 42 Participants | 124 Participants |
| Sex: Female, Male Male | 79 Participants | 91 Participants | 79 Participants | 249 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 126 | 0 / 121 |
| other Total, other adverse events | 0 / 126 | 0 / 126 | 0 / 121 |
| serious Total, serious adverse events | 0 / 126 | 0 / 126 | 0 / 121 |
Outcome results
Primary
PROMIS Asthma Impact Scale (v1.0, SF8a)
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Usual Care | PROMIS Asthma Impact Scale (v1.0, SF8a) | -7.8 T-score |
| ED-only | PROMIS Asthma Impact Scale (v1.0, SF8a) | -9.3 T-score |
| ED-plus-home | PROMIS Asthma Impact Scale (v1.0, SF8a) | -11.9 T-score |
Primary
PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Usual Care | PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a) | 0.0 T-score |
| ED-only | PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a) | 0.0 T-score |
| ED-plus-home | PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a) | 0.0 T-score |
Secondary
Childhood Asthma Control Test (cACT)
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Usual Care | Childhood Asthma Control Test (cACT) | 3.0 score |
| ED-only | Childhood Asthma Control Test (cACT) | 4.0 score |
| ED-plus-home | Childhood Asthma Control Test (cACT) | 5.5 score |
Secondary
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff
Count of participants who were provided documented discharge instructions for a follow-up appointment scheduled within 4 weeks of discharge
Time frame: At index ED discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff | 10 Participants |
| ED-only | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff | 62 Participants |
| ED-plus-home | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff | 56 Participants |
Secondary
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller
Count of participants who were provided documented discharge instructions to use inhaled corticosteroids or other controller
Time frame: At index ED discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller | 52 Participants |
| ED-only | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller | 80 Participants |
| ED-plus-home | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller | 87 Participants |
Secondary
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication
Count of participants who were provided documented discharge instructions to use an inhaled rescue medication
Time frame: At index ED discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication | 107 Participants |
| ED-only | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication | 125 Participants |
| ED-plus-home | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication | 118 Participants |
Secondary
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids
Count of participants who were provided documented discharge instructions to use systemic corticosteroids
Time frame: At index ED discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids | 77 Participants |
| ED-only | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids | 125 Participants |
| ED-plus-home | Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids | 118 Participants |
Secondary
Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits
Count of participants (children) with at least one all-cause ED or urgent care visit at 6 months
Time frame: 6 months post index ED discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care | Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits | 54 Participants |
| ED-only | Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits | 53 Participants |
| ED-plus-home | Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits | 44 Participants |
Secondary
Number of Participants With All-cause Hospitalizations
Count of participants (children) with at least one all-cause hospitalization at 6 months
Time frame: 6 months post index ED discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care | Number of Participants With All-cause Hospitalizations | 12 Participants |
| ED-only | Number of Participants With All-cause Hospitalizations | 11 Participants |
| ED-plus-home | Number of Participants With All-cause Hospitalizations | 9 Participants |
Secondary
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Usual Care | Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | 0.8 score |
| ED-only | Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | 1.1 score |
| ED-plus-home | Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | 1.2 score |
Secondary
PROMIS Anxiety (v1.0, SF4a)
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Usual Care | PROMIS Anxiety (v1.0, SF4a) | -3.2 T-score |
| ED-only | PROMIS Anxiety (v1.0, SF4a) | -3.8 T-score |
| ED-plus-home | PROMIS Anxiety (v1.0, SF4a) | -2.5 T-score |
Secondary
PROMIS Depression (v1.0, SF4a)
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Usual Care | PROMIS Depression (v1.0, SF4a) | 0.0 T-score |
| ED-only | PROMIS Depression (v1.0, SF4a) | 0.0 T-score |
| ED-plus-home | PROMIS Depression (v1.0, SF4a) | 0.0 T-score |
Secondary
PROMIS Fatigue (v1.0, SF4a)
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Usual Care | PROMIS Fatigue (v1.0, SF4a) | 0.0 T-score |
| ED-only | PROMIS Fatigue (v1.0, SF4a) | 0.0 T-score |
| ED-plus-home | PROMIS Fatigue (v1.0, SF4a) | -2.6 T-score |
Secondary
PROMIS Sleep Disturbance (v1.0, SF4a)
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Usual Care | PROMIS Sleep Disturbance (v1.0, SF4a) | 0.0 T-score |
| ED-only | PROMIS Sleep Disturbance (v1.0, SF4a) | 0.0 T-score |
| ED-plus-home | PROMIS Sleep Disturbance (v1.0, SF4a) | -1.9 T-score |
Secondary
Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider
Count of participants who attended follow-up appointment with patient-identifier asthma provider within 4 weeks of discharge
Time frame: 4 weeks post index ED discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care | Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider | 37 Participants |
| ED-only | Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider | 48 Participants |
| ED-plus-home | Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider | 57 Participants |
Secondary
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller
Count of participants who filled prescription for inhaled corticosteroids or other controller within 7 days of discharge
Time frame: 7 days post index ED discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care | Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller | 42 Participants |
| ED-only | Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller | 49 Participants |
| ED-plus-home | Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller | 69 Participants |
Secondary
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids
Count of participants who filled a prescription for systemic corticosteroids within 7 days of discharge
Time frame: 7 days post index ED discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care | Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids | 82 Participants |
| ED-only | Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids | 89 Participants |
| ED-plus-home | Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids | 79 Participants |