Telehealth-Enhanced Asthma Care for Home After the Emergency Room
ConditionAsthma in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorUniversity of Rochester
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
>2 days/wk with asthma symptoms in the past month,
>2 days/wk with rescue medication use in the past month,
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
430 Participants
are divided into 2 treatment groupsGroup A: Telehealth-Enhanced Asthma Care for Home After the Emergency RoomExperimental treatment 1 intervention
Group B: Enhanced Care (EC) Comparison GroupActive comparator 1 intervention
Trial outcomes
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
Time frame
12 monthsSecondary outcomes
1
Symptom-Free Days (SFD) in the past 2 weeks
The number of 24-hour periods within the previous 14 days that a child remained free of asthma symptoms (range: 0-14 days); a higher score indicates more days without symptoms. Reported by caregivers during scheduled telephone assessments.
Time frame
Baseline, 3 months, 6 months, 9 months, 12 months2
Caregiver-reported Asthma control (NHLBI)
Asthma control over the past 1 month, as based on caregiver report of recent symptoms, activity limitation, and medication use during scheduled telephone assessments.
Time frame
Baseline, 3 months, 6 months, 9 months, 12 months3
Missed school due to asthma in the past 2 weeks
We will ask caregivers to report how many days of school the child missed (if any) during the previous 2 weeks due to their asthma (range: 0-14 days).
Time frame
Baseline, 3 months, 6 months, 9 months, 12 months4
Missed work due to asthma in the past 2 weeks
We will ask caregivers to report how many days of work the caregiver missed (if any) during the previous 2 weeks due to their child's asthma (range: 0-14 days).
Time frame
Baseline, 3 months, 6 months, 9 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rochester
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov