Asthma Link: A Real World Application of School Supervised Asthma Therapy

University of Massachusetts, Worcester

Status: Completed

Conditions: Childhood Asthma

Treatments: Other: Asthma Link; Other: Enhanced Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04942379

5K23HL150341 (U.S. NIH Grant/Contract)

H00016378

Details and patient eligibility

About

The goal of this study is to assess the feasibility of a clinical trial to evaluate the impact and process of deploying school-supervised asthma therapy in a real-world setting for children with poorly controlled asthma (aged 6-17 years).

Full description

The proposed 4-site pilot cluster randomized controlled trial will assess the feasibility of conducting a clinical trial of Asthma Link, a real-world school-supervised asthma therapy program. We will compare the impact of Asthma Link deployed in 2 pediatric practice sites versus Enhanced usual care deployed in 2 comparator sites, with 18 parent-child dyads enrolled per site (N=72 dyads).

Primary trial outcomes will be participant recruitment, retention, and intervention fidelity. Secondary trial outcomes will be differences in the frequency of asthma symptoms, emergency department visits, hospital admissions, courses of oral corticosteroids, spirometry values, medication adherence and school absences between intervention and enhanced usual care sites at 3, 6 and 12 month follow up. Additionally we will assess process outcomes (acceptability, adoption, costs, sustainability).

Enrollment: 66 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

STUDY INCLUSION/EXCLUSION CRITERIA:

Child Inclusion Criteria:

• Meet the eligibility criteria for Asthma Link (as described below)
• Enrolled in Asthma Link (if randomized to the Asthma Link Condition)
• Able and willing to provide informed assent

Child Exclusion Criteria:

• Unable or unwilling to provide informed assent
• Diagnosis of a serious co-morbid illness during the past 5 years
• Developmental delay that would prevent study participation.
• Planning on moving from primary residence or moving outside of the school district in the next 1 year
• A sibling to a child participating in this study

Parent Inclusion Criteria:

• Parent/guardian to patient
• 18 years or older
• Able to understand and communicate in English or Spanish
• Able and willing to provide informed consent.

Parent Exclusion Criteria:

• Adults lacking capacity
• Prisoners

Medical Provider, School Nurse, Asthma Champion Inclusion Criteria:

• Able and willing to provide informed consent

Medical Provider, School Nurse, Asthma Champion Exclusion Criteria:

• Unable or unwilling to provide informed consent

Child eligibility for children enrolled in Asthma Link:

• children aged 6-17 years (enrolled in grade 1-12)
• prescribed daily inhaled corticosteroid (ICS) for asthma
• 1 or more courses of oral steroids in the past 2 years OR 1 or more hospitalizations or ED visits for asthma in the past 2 years OR 1 or more sick visits for asthma in the past year OR Asthma Control Test (ACT) score <19
• parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says "Yes" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks
• able and willing to assent
• parental permission
• English or Spanish speaking

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Asthma Link

Experimental group

Description:

Site providers will be trained to efficiently discuss school-supervised medication administration with families and school nurses. Providers identify children with poorly controlled asthma and poor medication adherence and offer enrollment in Asthma Link to provide school-supervised asthma therapy. Ongoing communication occurs between the pediatric practice, school nurse and families through electronic medical record messaging and phone communication. Data will be collected at baseline (study entry) and at 3-, 6-and 12-month follow-up.

Treatment:

Other: Asthma Link

Enhanced Usual Care

Active Comparator group

Description:

Sites will receive pediatric pulmonologist-delivered training and a workbook for pediatric practices to provide to patients on behavioral strategies to help promote asthma medication adherence. Providers identify children with poorly controlled asthma and poor medication adherence and offer enrollment to this Enhanced Usual Care condition of study (receipt of workbook). Data will also be collected at baseline (study entry) and at 3-, 6-and 12-month follow-up.

Treatment:

Other: Enhanced Usual Care