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

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).

Study Overview

• Status: Completed
• Conditions: Childhood Asthma
• Intervention / Treatment: Other: Asthma Link; Other: Enhanced Usual Care

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asthma Link; 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.	Other: Asthma Link; Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Active Comparator: Enhanced Usual Care; 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.	Other: Enhanced Usual Care; Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment procedures assessed by number of patients screened	Research staff will track number of patients screened during enrollment process.	Baseline
Recruitment procedures assessed by number of eligible participants	Research staff will track number of eligible participants who meeting study criteria during the enrollment process.	Baseline
Recruitment procedures assessed by number of patients recruited into the study	Research staff will track number of patients recruited into the study.	Baseline
Recruitment procedures assessed by number of eligible patients that refused to participate.	Research staff will track the number of patients that refused to participate in the study along with the reasons for refusal.	Baseline
Retention of study participants (drop out)	Research staff to track number of participants who drop out of the study and note reasons for not completing study.	Up to end of study, approximately 12 months
Retention of study participants (lost to follow-up)	Research staff to track number of participants lost to follow-up and reasons for not completing study.	Up to end of study, approximately 12 months
Intervention Fidelity - Pediatric Practice	Research staff to assess for intervention fidelity within the pediatric practice through a checklist for pediatric staff to assess percentage of eligible children enrolled.	Baseline
Intervention Fidelity - Percentage of enrolled students receiving intervention	Research staff to assess for intervention fidelity by school nurse report of percentage of enrolled students receiving supervised therapy.	Up to end of study, approximately 12 months
Intervention Fidelity - School nurse and family participation	Research staff to assess for intervention fidelity by school nurse checklist of each enrolled child attending daily school nurse sessions and his/her family bringing medication to school.	Up to end of study, approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability - Participants	Research staff will assess acceptability of the study among stakeholders (parent-child dyads, medical providers, school nurses) via a survey in which we will ask stakeholders to rate each component of the Asthma Link intervention using a study specific Acceptability scale ranging from 1 (strongly disagree) to 5 (strongly agree). Qualitative interviews will be performed with stakeholders at 12 months	3 months, 6 months, 12 months
Adoption of Asthma Link Intervention - Medical Provider	Research staff will assess adoption of the intervention via Pediatric practice log to track number of providers offering Asthma Link.	Baseline, 3 months, 6 months, 12 months
Adoption of Asthma Link Intervention - Participant	Research staff will assess adoption of the intervention via survey to family at each survey timepoint of study to assess ability to obtain 2 inhalers (one for home and one for school) and deliver medicine to school.	3 months, 6 months, 12 months
Adoption of Asthma Link Intervention - School Nurse	Research staff will assess adoption of the intervention via school nurse log to track family bringing in medicine to school and frequency of child coming to nurses office to receive the medication.	Baseline, 3 months, 6 months, 12 months
Cost effectiveness of intervention	Research staff will use survey questions to assess time and costs for school nurses to review the toolkit and administer the intervention, pediatric providers to implement the program, and parents to participate in the intervention	School nurses and pediatric practices 6 and 12 months/Parents 3, 6 and 12 months
Sustainability of Intervention	Research staff will use a survey questions to parents, pediatric practice staff and school staff	3 months, 6 months, 12 months
Asthma Symptoms - Spirometry	Research staff will assess asthma symptoms utilizing spirometry to measure Forced Expiratory Volume.	Baseline, 3 months, 6 months, 12 months
Asthma Symptoms - Asthma Control Test	Research staff will assess asthma symptoms utilizing the validated measure: Asthma Control Test (ACT) which consists of parent's assessment of level of control over child's asthma symptoms in the previous 4 weeks.	Baseline, 3 months, 6 months, 12 months
Asthma Symptoms - Maximum Symptoms Days	Research staff will assess asthma symptoms utilizing the validated measure: Maximum Symptom Days (the largest value of the number of days in the previous 2 weeks that a parent reports that their child experienced a) cough, wheezing, or shortness of breath, b) slowed activities due to symptoms, or 3)nocturnal awakening due to these symptoms.	Baseline, 3 months, 6 months, 12 months
Frequency of healthcare utilization over time	Research staff will assess the frequency of healthcare utilization (# of emergency room visits, # of hospital admissions, # of oral steroid courses, and # of urgent care visits) due to asthma through parent report on surveys and medical record review.	Baseline, 3 months, 6 months, 12 months
Medication Adherence	Research staff will assess medication adherence via a survey questions administered to parents and through pharmacy refill data.	Baseline, 3 months, 6 months, 12 months
School absences	Research staff will assess school absences via parent report and school nurse report	Baseline, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Michelle Trivedi, MD, University of Massachusetts Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): March 27, 2023
• Study Completion (Actual): August 22, 2023

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: asthma; medication adherence; pragmatic trial; childhood asthma; stakeholder engagement; school-supervised asthma therapy; real-world
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: H00016378; 5K23HL150341 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No