Asthma, Children
Conditions
Brief summary
The Asthma Action at Erie Trial compares the current best practice in asthma self-management education (certified asthma educator services) to an integrated community health worker (CHW) home intervention in which the real-life challenges of patients and the health care system are taken fully into account. This trial will provide clarity as to the expected effect size, cost savings, and resources needed to integrate asthma CHWs into clinical practice.
Detailed description
The Asthma Action at Erie Trial will test the ability of a community health worker (CHW) intervention with three important modifications to achieve asthma control in high-risk children. These modifications are: 1) CHWs will be integrated into both the clinical and the home setting, 2) A system for directly addressing mental health and psychosocial barriers will be provided, and 3) Participants will be provided only materials and equipment for trigger remediation that are supported by the current medical reimbursement system. To test this intervention, a two-arm behavioral randomized controlled trial (N=220) will be conducted in partnership with a federally-qualified health center (FQHC) serving a low income, minority population that is at high-risk for significant asthma morbidity. The intervention arm will receive an integrated CHW home intervention for pediatric asthma education. The comparison arm will received clinic-based certified asthma educator (AE-C) services. Primary Aim 1 is to assess the efficacy of the integrated CHW home asthma intervention, relative to clinic-based AE-C education over 12-months, as demonstrated by asthma control. Specific Aim 2 is to assess maintenance of intervention efficacy, as demonstrated by asthma control at 18 and 24 months after randomization. Specific Aim 3 is to determine the cost-effectiveness at 12-months of CHW and AE-C intervention delivery, and additional costs or savings related to asthma exacerbations at 12- and 24-months. Specific Aim 4 is to assess the efficacy of the integrated CHW home asthma intervention relative to clinic-based AE-C education, as demonstrated by asthma control, among those experiencing depression, stress, and/or a post-traumatic stress disorder.
Interventions
BEHAVIORALCommunity Health Worker
A community health worker is para-professional who performs education, case management, and social support.
BEHAVIORALCertified asthma educator
A certified asthma educator has is certified and performs asthma education.
Sponsors
Erie Family Health Center
Rush University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
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 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Child is a patient at Erie Family Health Center * Child is age 5-16 at the start of the study * Child lives with the index caregiver at least 5 days out of the week * Child has uncontrolled asthma. This is defined as a score of 1.25 or greater on the Asthma Control Questionnaire, or report of oral corticosteroid use in the past year * Family has a working telephone
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test/Childhood Asthma Control Test at 12-months | assessed 12-months from baseline, assessed over past 4 weeks | Asthma Control Test (12 years or older) or Childhood Asthma Control Test (under 12 years old) minimum 5, maximum 27, higher score means better asthma control |
| Activity Limitation at 12-months | assessed 12-months after baseline, assessed over past 14 days | Days of activity limitation over past 14 days minimum 0, maximum 14, higher means worse asthma control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Questionnaire at 12-months | assessed 12-months after baseline, prior week assessed | Asthma Control Questionnaire minimum 0, maximum 6, higher score means worse asthma control |
| Health Care Utilization at 12-months | assessed 12-months after baseline, assessed from baseline to 12-months | Any ED visits or hospitalizations for asthma (each ED visit or hospitalization is a single event, ED visits that transition into hospitalizations are coded as one event) |
| Costs of Intervention Delivery | assessed 12-months from baseline, assessed from baseline to 12-months | This measure is the total dollars spent to deliver the intervention by arm. Costs include CHW and AE-C salaries, supervision, training costs, and intervention materials that resulted in 84 AE-visits and 722 CHW visits. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Community Health Worker Participants in this arm will be offered 10 home visits in a 12-month period from community health workers (CHWs). Visits will cover a core asthma curriculum and provide social support.
Community Health Worker: A community health worker is para-professional who performs education, case management, and social support. | 108 |
| Certified Asthma Educator Participants in this arm will be offered 2 education sessions with a certified asthma educator in the clinic at start of the study and again at 6-months. These sessions will be followed by a telephone call from the certified asthma educator several weeks after the sessions.
Certified asthma educator: A certified asthma educator has is certified and performs asthma education. | 115 |
| Total | 223 |
Baseline characteristics
| Characteristic | Community Health Worker | Certified Asthma Educator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 108 Participants | 115 Participants | 223 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.3 years STANDARD_DEVIATION 2.9 | 9.5 years STANDARD_DEVIATION 3.2 | 9.4 years STANDARD_DEVIATION 3 |
| Race/Ethnicity, Customized Black race child | 18 Participants | 21 Participants | 39 Participants |
| Race/Ethnicity, Customized Hispanic ethnicity child | 92 Participants | 98 Participants | 190 Participants |
| Race/Ethnicity, Customized Not Black race child | 90 Participants | 93 Participants | 183 Participants |
| Race/Ethnicity, Customized Not Hispanic ethnicity child | 16 Participants | 17 Participants | 33 Participants |
| Region of Enrollment United States | 108 participants | 115 participants | 223 participants |
| Sex: Female, Male Female | 46 Participants | 52 Participants | 98 Participants |
| Sex: Female, Male Male | 62 Participants | 63 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 115 |
| other Total, other adverse events | 0 / 108 | 0 / 115 |
| serious Total, serious adverse events | 0 / 108 | 0 / 115 |
Outcome results
Primary
Activity Limitation at 12-months
Days of activity limitation over past 14 days minimum 0, maximum 14, higher means worse asthma control
Time frame: assessed 12-months after baseline, assessed over past 14 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Community Health Worker | Activity Limitation at 12-months | 0.42 ratio of days |
| Certified Asthma Educator | Activity Limitation at 12-months | 0.88 ratio of days |
Primary
Asthma Control Test/Childhood Asthma Control Test at 12-months
Asthma Control Test (12 years or older) or Childhood Asthma Control Test (under 12 years old) minimum 5, maximum 27, higher score means better asthma control
Time frame: assessed 12-months from baseline, assessed over past 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Community Health Worker | Asthma Control Test/Childhood Asthma Control Test at 12-months | 21.23 score on a scale |
| Certified Asthma Educator | Asthma Control Test/Childhood Asthma Control Test at 12-months | 20.58 score on a scale |
Secondary
Asthma Control Questionnaire at 12-months
Asthma Control Questionnaire minimum 0, maximum 6, higher score means worse asthma control
Time frame: assessed 12-months after baseline, prior week assessed
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Community Health Worker | Asthma Control Questionnaire at 12-months | 0.80 score on a scale |
| Certified Asthma Educator | Asthma Control Questionnaire at 12-months | 0.88 score on a scale |
Secondary
Costs of Intervention Delivery
This measure is the total dollars spent to deliver the intervention by arm. Costs include CHW and AE-C salaries, supervision, training costs, and intervention materials that resulted in 84 AE-visits and 722 CHW visits.
Time frame: assessed 12-months from baseline, assessed from baseline to 12-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Community Health Worker | Costs of Intervention Delivery | 53390 dollars spent per arm on intervention |
| Certified Asthma Educator | Costs of Intervention Delivery | 11373 dollars spent per arm on intervention |
Secondary
Health Care Utilization at 12-months
Any ED visits or hospitalizations for asthma (each ED visit or hospitalization is a single event, ED visits that transition into hospitalizations are coded as one event)
Time frame: assessed 12-months after baseline, assessed from baseline to 12-months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Community Health Worker | Health Care Utilization at 12-months | 0.11 events |
| Certified Asthma Educator | Health Care Utilization at 12-months | 0.20 events |