Telehealth-Enhanced Asthma Care for Home After the Emergency Room

Not Applicable

Recruiting

• Conditions: Asthma in Children
• Interventions: Behavioral: Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER); Behavioral: Enhanced Care (EC)

• Registration Number: NCT05844891
• Lead Sponsor: University of Rochester

Brief Summary

The investigators propose a randomized controlled trial of Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) vs. enhanced care (EC). TEACH-ER includes: 1) brief, pictorial, and health literacy-informed asthma education in the ED, with color- and shape-coded labels provided for home asthma medications; 2) virtual primary care follow-up within 1 week of discharge using in-home telemedicine (Zoom) when possible, featuring provider prompts for guideline-based preventive therapy and home delivery of prescribed medications with pictorial action plans; 3) two additional in-home virtual visits to reinforce teaching, review treatment plans, label medications, and support effective management practices. The investigators will enroll 430 children (ages 3-12 yrs) from the two dedicated pediatric EDs in our region, and follow all participants for a 12-month period. The investigators will call caregivers to complete blinded follow-up telephone surveys at 3, 6, 9, and 12 months after discharge. The investigators will assess the effectiveness of TEACH-ER in reducing the need for additional asthma-related ED visits or hospitalizations in the 1-months after enrollment. Additional outcomes of interest include asthma symptoms, medication adherence, absenteeism from work and school, quality of life, and the delivery of care consistent with national asthma care guidelines.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-06
• Study Start: 2024-04-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Primary Completion: 2028-03-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

Not provided

Exclusion Criteria

• An inability to speak and understand English. Parents (and children) with low literacy / health-literacy skills will be eligible, as survey instruments will be administered verbally and educational materials will be designed for low-literacy populations.
• No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible location). If a subject does not have access to an appropriate device for Zoom visits at home, we will provide a device with required data plan.
• Other significant medical conditions, including cystic fibrosis, congenital heart disease, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
• Children in foster care or other situations in which consent cannot be obtained from a legal guardian.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telehealth-Enhanced Asthma Care for Home After the Emergency Room	Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)	New model of patient-centered asthma management.
Enhanced Care (EC) Comparison Group	Enhanced Care (EC)	Standard emergency department care for asthma exacerbations, enhanced through a report of recent symptoms sent to PCPs, and systematic feedback on asthma management/care at intervals that parallel the TEACH-ER group's telemedicine assessments.

Primary Outcome Measures

Name	Time	Method
Number of asthma-related hospitalizations and emergency department visits after discharge	12 months	Asthma-related hospitalizations or emergency department visits, and drawn from objective healthcare utilization data in the electronic health record

Secondary Outcome Measures

Name	Time	Method
Caregiver-reported Asthma control (NHLBI)	Baseline, 3 months, 6 months, 9 months, 12 months	Asthma control over the past 1 month, as based on caregiver report of recent symptoms, activity limitation, and medication use during scheduled telephone assessments.
Missed school due to asthma in the past 2 weeks	Baseline, 3 months, 6 months, 9 months, 12 months	We will ask caregivers to report how many days of school the child missed (if any) during the previous 2 weeks due to their asthma (range: 0-14 days).
Caregiver quality of life	[Time Frame: 2 months, 4 months, 6 months]	The Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ) is a well-established, validated measure of caregiver quality of life over the previous 1 week, as reported by caregivers during scheduled telephone assessments (score range: 1-7 points; 1 indicates severe impairment, 7 indicates no impairment).
Symptom-Free Days (SFD) in the past 2 weeks	Baseline, 3 months, 6 months, 9 months, 12 months	The number of 24-hour periods within the previous 14 days that a child remained free of asthma symptoms (range: 0-14 days); a higher score indicates more days without symptoms. Reported by caregivers during scheduled telephone assessments.
Missed work due to asthma in the past 2 weeks	Baseline, 3 months, 6 months, 9 months, 12 months	We will ask caregivers to report how many days of work the caregiver missed (if any) during the previous 2 weeks due to their child's asthma (range: 0-14 days).
Caregiver-reported Medication adherence	Baseline, 3 months, 6 months, 9 months, 12 months	Recent adherence with prescribed controller therapy as reported by caregivers during scheduled telephone assessments using the Medication Adherence Report Scale (5-25 points; higher scores indicate higher levels of reported adherence).

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States