Recruiting

Telehealth Care

Sponsor:

University of Rochester

Code:

NCT05844891

Conditions

Asthma in Children

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Not accepted

Interventions

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

Enhanced Care (EC)

Study Details

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

Study ID

NCT05844891

Start date

Apr 1, 2024

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria (all criteria must be met):

  • 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:

1. >2 days/wk with asthma symptoms in the past month,
2. >2 days/wk with rescue medication use in the past month,
3. >2 days/month with nighttime symptoms in the past month (vs. 1-2 nights per month if 3-4 years old), or
4. ≥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).

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

Enrollment

430 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Telehealth-Enhanced Asthma Care for Home After the Emergency Room

New model of patient-centered asthma management.

active comparator: Enhanced Care (EC) Comparison Group

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.

Interventions

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

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.

Enhanced Care (EC)

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.

Primary outcome measure

  • Number of asthma-related hospitalizations and emergency department visits after discharge [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Sean Frey, MD, MPH

585-275-1920sean_frey@urmc.rochester.edu

Jill Halterman, MD, MPH

585-275-5798jill_halterman@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-05-04.