Clinical trial NCT05844891: Telehealth-Enhanced Asthma Care for Home After the Emergency Room
Official title: Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-05-06
Enrollment: 430
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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 Monroe County, NY.

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.

Primary outcomes:
measure: Number of asthma-related hospitalizations and emergency department visits after discharge
timeFrame: 12 months
Secondary outcomes:
measure: Symptom-Free Days (SFD) in the past 2 weeks
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Caregiver-reported Asthma control (NHLBI)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Missed school due to asthma in the past 2 weeks
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Missed work due to asthma in the past 2 weeks
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Caregiver-reported Medication adherence
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Caregiver quality of life
timeFrame: [Time Frame: 2 months, 4 months, 6 months]
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: