Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
Purpose
The overall goal of this research study is to evaluate a multi-level program called PRAGMATIC-S to improve the delivery of guideline-based asthma care through a unique partnership between clinical practices and schools. PRAGMATIC-S represents a novel approach that addresses multiple barriers to adherence by bridging primary care and schools, ensuring delivery of guideline-based asthma care to urban children across these settings thereby improving adherence to therapy and clinical outcomes.
Condition
- Asthma in Children
Eligibility
- Eligible Ages
- Between 4 Years and 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Physician-diagnosed asthma documented in EHR - Persistent asthma, not on controller medications or uncontrolled asthma despite therapy (with any one of the following per age-specific guidelines: in past month, >2 days/week with symptoms, >2 days/week using rescue medication, >2 days/month with nighttime symptoms, or >2 episodes/year that required systemic corticosteroids - Age 4 to 12 years, inclusive, attending pre-kindergarten through 7th grade in public / charter / private schools in New York City (the Bronx primarily) and also schools in lower Hudson Valley (Eastchester, Westchester, Rockland, Yonkers) - Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel - Consent from primary caregiver and assent from child (age ≥7 years). If there are eligible siblings with exact same asthma severity/control screening results, one child will be randomly selected to participate, otherwise the sibling with worse asthma symptoms will be selected. - Presence of a phone to conduct surveys and smartphone, iPad or computer to electronically complete and e-sign MAF
Exclusion Criteria
- Family plans to leave school or city within 6 months - Significant medical conditions (e.g., congenital heart disease, cystic fibrosis, or other chronic lung disease) - Children in foster care or other situations in which consent cannot be obtained from a legal guardian - Participation in concurrent asthma intervention study - Severe developmental delay (e.g., severe autism) precluding completion of asthma control questionnaire
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Cluster randomized design. Prior to participant enrollment, each practice will be matched into 9 pairs based on size of the practice and provider type. Practices will then be randomly selected within each pair to receive PRAGMATIC-S or remain as an Enhanced Usual Care (eUC) site. Practices will join study in 5 waves (2-4 practices per wave).
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Follow up assessments will be collected by blinded interviewers.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PRAGMATIC-S |
Primary Care Providers (PCPs) will use guideline-based prompts within EHR; PCPs and caregivers will complete medication administration forms electronically with forms routed directly to schools to receive asthma medications at the school, and asthma outreach workers will serve as liaison between families, PCPs, schools and provide care coordination and support. |
|
|
No Intervention Enhanced Usual Care |
Standard of care EHR clinician prompts for guideline-based asthma care |
|
Recruiting Locations
The Bronx, New York 10467
More Details
- Status
- Recruiting
- Sponsor
- Montefiore Medical Center
Detailed Description
The research team will conduct a cluster randomized controlled trial, enrolling 420 children, ages 4-12, from 18 Montefiore clinics during office visits. Children in the intervention group (PRAGMATIC-S) will receive updated guideline-based care prompts, with providers completing the medication administration form (MAF), electronically signing it, and routing it directly to the school via the EHR system. Asthma Outreach Worker (AOW) care coordination will support daily adherence to prescribed treatments at home and school. Children in the control group will receive enhanced usual care, which includes EHR prompts for guideline-based care but without the additional PRAGMATIC-S components. Participants will be followed for 12 months. Outcomes will be assessed as outlined in this registration.