Asthma Action at Erie Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 5 - 16 |
| Updated: | 10/13/2018 |
| Start Date: | April 1, 2015 |
| End Date: | March 31, 2020 |
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.
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.
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.
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.
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:
- Exclusion criteria include family not fluent in English or Spanish, family lives in
temporary housing such as a shelter, caregiver does not have permanent custody of
child, or child has significant developmental delays or co-morbidities that would
limit their ability to participate in the program.
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