Telehealth-Enhanced Asthma Care for Home After the Emergency Room
Part of paid clinical trials in Rochester, New York.
- Sponsor
- University of Rochester
- Study ID
- NCT05844891
- Status
- Recruiting
Conditions
- Asthma in Children
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Years - 12 Years
- Healthy Volunteers
- Not accepted
Interventions
- Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) — BEHAVIORALTEACH-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) — BEHAVIORALSimilar 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.
Study Details
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.
Key Dates
- Start date
- Apr 1, 2024
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 430 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Telehealth-Enhanced Asthma Care for Home After the Emergency RoomNew model of patient-centered asthma management.
- Active Comparator: Enhanced Care (EC) Comparison GroupStandard 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 Measure
Number of asthma-related hospitalizations and emergency department visits after discharge [ Time Frame: 12 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 |
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