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Clinical Trials/NCT05844891
NCT05844891
Recruiting
Not Applicable

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

University of Rochester1 site in 1 country430 target enrollmentApril 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma in Children
Sponsor
University of Rochester
Enrollment
430
Locations
1
Primary Endpoint
Number of asthma-related hospitalizations and emergency department visits after discharge
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
June 30, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sean Frey

Associate Professor

University of Rochester

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 12 months

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

Secondary Outcomes

  • 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)
  • Caregiver quality of life([Time Frame: 2 months, 4 months, 6 months])
  • Symptom-Free Days (SFD) 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 Sites (1)

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