ED-Initiated School-based Asthma Medication Supervision

NCT03952286 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 1R34HL137851
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a common chronic condition that causes substantial morbidity among children and much of it is attributable to medication non-adherence. The National Asthma Education and Prevention Program (NAEPP) and the American Academy of Asthma, Allergy, and Immunology have urged others to develop more effective adherence programs.Schools are a logical setting to deploy such interventions because they are where children congregate, spend much of their day, and are frequently monitored. Because many schools serve a high proportion of minority and low-income students, engaging them presents a unique opportunity to reach populations who experience the greatest burden of preventable morbidity. Supervising inhaled corticosteroid (ICS) use in the school setting can increase medication adherence and reduce episodes of poor asthma control. Under certain conditions, it can also be cost-effective. However, recruiting children from school settings tends to enroll children with mild asthma and infrequent health care use. Therefore, initiating supervised treatment in these children tends to burden school personnel with unnecessary work and diminishes the program's cost-effectiveness. To address this inefficiency, the investigators propose to recruit children who are discharged from the Hospital Emergency Departments (EDs) following successful treatment of an asthma attack. Such children have much higher risk of a future asthma attack than their peers. The Pediatric Emergency Care Applied Research Network (PECARN) com- prises10 hospital-affiliated EDs that serve 1 million acutely ill and injured children annually. Their primary research mission is to reduce childhood morbidity and mortality by establishing creative partnerships between emergency medical service providers and their surrounding communities. The networks size and geographic diversity make it uniquely situated to develop, implement, and evaluate the feasibility and effectiveness of ED-Initiated School-Based Asthma Medication Supervision (ED-SAMS). Approximately one-third of children treated for an asthma attack within PECARN experience a second ED-managed attack within 6 months. While the NAEPP guidelines recommend that long-term ICS treatment should be initiated at ED discharge, \<20% of children actually receive a prescription for controller therapy. Observational data indicate that patients who use ICS following discharge are almost half as likely as non-users to experience a repeat ED visit. Many have also argued that ED-initiated treatment could be cost-effective. However, simply providing patients with a prescription does not ensure that they will actually use it once discharged. To ensure better medication adherence, the investigators propose to dispense ICS at discharge and supervise its use in the school setting.

Conditions

Asthma; Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 90-day Emergency Department (ED) Recidivism

  90-day Emergency Department (ED) Recidivism as measured by the number of participants that return to the ED for asthma exacerbation within 90 days of discharge

  90 days

Secondary Outcomes (1)

• Cost-effectiveness

  90 days

Study Arms (2)

Intervention

EXPERIMENTAL

ED-Dispensing with home and school supervision

Drug: ED-Dispensing home and school supervision

Control

OTHER

ED-Dispensing with home supervision

Drug: ED-Dispensing home and school supervision

Interventions

ED-Dispensing home and school supervision DRUG

1. Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department), 2. 360 ug of budesonide inhalation powder once-daily for at-home use, and 3. albuterol sulfate as needed for relief of acute respiratory symptoms.

Control; Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 6-12 years of age; AND
• Treated for an asthma exacerbation as determined clinically by the principal ED provider based on symptoms such as shortness-of-breath, cough, and wheezing; AND
• Symptoms must improve following more than 1 dose of albuterol and more than 1 dose of systemic corticosteroids such that he/she can be safely discharged home; AND
• Must have physician-diagnosed

You may not qualify if:

• Attends a non-participating school; OR
• Attends a participating school less than 5x/week; OR
• Enrolled in another research study; OR
• Patients who are hospitalized; OR
• The patient or their consenting parent/guardian does not speak English or Spanish; OR
• ICU admissions for asthma in the past year; OR
• History of more than 2 hospitalizations for asthma in past year; OR
• History of more than 2 controller medications for asthma in the past 30 days; OR
• Study medication represents a step-down in asthma therapy in the judgement of the ED physician; OR
• Parent does not have a cell phone; OR
• Parent cannot send and receive text messages.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Asthma & Airway Disease Research Center

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• Gerald LB, Gerald JK, VanBuren JM, Lowe A, Guthrie CC, Klein EJ, Morrison A, Startup E, Denninghoff K. Randomized trial of the feasibility of ED-initiated school-based asthma medication supervision (ED-SAMS). Pilot Feasibility Stud. 2021 Sep 27;7(1):179. doi: 10.1186/s40814-021-00913-0.

  PMID: 34579785 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Ashley A. Lowe
• Organization: University of Arizona Asthma & Airway Disease Research Center

aaray@email.arizona.edu

5206268814

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1 receives the intervention: ED-Initiated School-based Asthma Medication Supervision (school and home asthma medication supervision). Group 2 receives usual care (home asthma medication supervision).

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 16, 2019
• Study Start: August 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: January 1, 2021
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2022-05

Locations

US (1)