Telehealth-Enhanced Asthma Care for Home After the Emergency Room

NCT05844891 | Recruiting DMC

• 2 other identifiers: 00008286R01HL169466
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Number of asthma-related hospitalizations and emergency department visits after discharge

  Asthma-related hospitalizations or emergency department visits, and drawn from objective healthcare utilization data in the electronic health record

  12 months

Secondary Outcomes (6)

• Symptom-Free Days (SFD) in the past 2 weeks

  Baseline, 3 months, 6 months, 9 months, 12 months

• Caregiver-reported Asthma control (NHLBI)

  Baseline, 3 months, 6 months, 9 months, 12 months

• Missed school due to asthma in the past 2 weeks

  Baseline, 3 months, 6 months, 9 months, 12 months

• Missed work due to asthma in the past 2 weeks

  Baseline, 3 months, 6 months, 9 months, 12 months

• Caregiver-reported Medication adherence

  Baseline, 3 months, 6 months, 9 months, 12 months

Study Arms (2)

Telehealth-Enhanced Asthma Care for Home After the Emergency Room

EXPERIMENTAL

New model of patient-centered asthma management.

Behavioral: Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)

Enhanced Care (EC) Comparison Group

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Care (EC)

Interventions

Enhanced Care (EC) BEHAVIORAL

Similar to children in the TEACH-ER group, participants in the EC group will receive a symptom assessment using NHLBI guidelines, a recommendation for appropriate preventive medications, and asthma education materials given at the time of the ED visit. After baseline and randomization, we will send the child's PCP a symptom report with guideline-based recommendations for preventive care and recommend a follow-up visit with the PCP. We will also give all providers a summary of the current national guidelines. We will provide systematic feedback to the family and child's PCP at intervals that parallel the TEACH-ER group's telemedicine assessments. This feedback will include prompting caregivers to schedule a recommended follow-up appointment with the PCP, and encouraging providers to adhere to the NHLBI guidelines. While participants will not be blinded to their group allocation, they will be told that they are randomly assigned to two different ways of approaching asthma management.

Enhanced Care (EC) Comparison Group

Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) BEHAVIORAL

TEACH-ER aims to provide primary care management and educational support for families managing childhood asthma throughout the transition from emergency department to home, and includes several core components: 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 (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. Virtual visits will be completed using the Zoom platform on smartphones or other compatible devices. We anticipate that all three telehealth visits (1 provider visit, 2 educator visits) will be completed within 2 months of enrollment.

Telehealth-Enhanced Asthma Care for Home After the Emergency Room

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Physician diagnosis of asthma, based on review of medical records and/or caregiver report.
• Current emergency visit for an acute asthma exacerbation, requiring treatment with rescue medication.
• Persistent asthma or poor asthma control for which a daily controller medication is recommended by NHLBI guidelines, defined as any 1 of the following:
• \>2 days/wk with asthma symptoms in the past month,
• \>2 days/wk with rescue medication use in the past month,
• \>2 days/month with nighttime symptoms in the past month (vs. 1-2 nights per month if 3-4 years old), or
• ≥1 other episode of asthma during the past year that required systemic corticosteroids (vs. during the past 6 months if 3-4 years old).
• Child age between ≥3 and ≤12 years.
• Child and caregiver live in the greater Rochester, NY metropolitan area (Monroe, Wayne, Ontario, Livingston, Genesee, and Orleans Counties)
• Emergency severity index triage scores of 2-5 (total range 1-5; scores of 1 indicate the highest acuity and likelihood of hospitalization).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants conducting telephone follow-up assessments 3, 6, 9, and 12 months after enrollment will be blinded to group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 6, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)