- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02752165
Telemedicine Enhanced Asthma Management Through the Emergency Department (TEAM-ED)
September 3, 2025 updated by: Jill Halterman, University of Rochester
In the US, children from minority ethnic and racial backgrounds suffer disproportionately from asthma and account for substantially more emergency department (ED) visits and hospitalizations than non-minority children.
While NHLBI guidelines recommend daily preventive medications for all children with persistent asthma to prevent morbidity as well as ED visits and hospitalizations, many children who should receive preventive medications are not receiving them.
This is in part because children presenting to the ED for an acute asthma exacerbation rarely receive preventive asthma care, due to the ED's focus on acute, episodic care.
The NHLBI guidelines recommend that children follow-up with a primary care provider (PCP) within 1-4 weeks of the ED visit.
The post-ED follow-up visit is an opportunity for the PCP to prescribe effective preventive asthma medications, step-up medication for children who demonstrate poor control, promote adherence, and provide education on asthma self-management and trigger control.
However, rates for follow-up after an asthma-related ED visit are extremely low, and preventive care is delivered inconsistently even when children are seen in follow-up.
In the investigators' prior work they have found that a provider prompting intervention can enhance the delivery of guideline-based preventive asthma treatments at the time of a primary care office visit and ultimately reduce morbidity.
They have also found that telemedicine can link children with persistent asthma to a provider for optimal chronic illness management.
The goal of this project is to use a novel telemedicine-based program to facilitate primary care follow-up and promote the delivery of guideline-based preventive care for high-risk children presenting to the ED for an asthma exacerbation.
The investigators will utilize a 2-group randomized trial to test the TEAM-ED intervention.
The intervention includes: 1) a telemedicine assessment at the child's school within one week of discharge from the ED and completed by a PCP, 2) 'point-of-care' prompting to promote the provision of guideline-based preventive care during the telemedicine visit, and 3) two additional telemedicine-assisted follow-up assessments to assure optimal response to treatment and tailor the care regimen as needed.
The investigators will assess the effectiveness of the program in reducing respiratory morbidity and improving preventive asthma care, with follow-up assessments at 3, 6, 9, and 12 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
384
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 12 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Prior physician diagnosis of asthma
- current emergency visit for an acute asthma exacerbation, requiring nebulized albuterol therapy
- Persistent or poor control of asthma, defined by NHLBI guidelines
Exclusion Criteria:
- Inability to speak and understand either English or Spanish
- No access to a phone for follow-up surveys
- Participation in another asthma study at the time of enrollment, or a sibling participating in this or another study Other significant medical conditions that could interfere with assessment of asthma-related measures
- children in foster care or other situations in which consent cannot be obtained from a legal guardian
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TEAM-ED Intervention Group
Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting
|
Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting
|
|
Active Comparator: Enhanced Usual Care
Report of symptoms to primary care physician
|
Report of symptoms to primary care physician
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Symptom-Free Days in the Prior 2 Weeks
Time Frame: At the 3-month follow-up assessment
|
Number of days without symptoms in the prior 2 weeks
|
At the 3-month follow-up assessment
|
|
Number of Symptom-Free Days in the Prior 2 Weeks
Time Frame: At the 6-month follow-up assessment
|
Number of days without symptoms in the prior 2 weeks
|
At the 6-month follow-up assessment
|
|
Number of Symptom-Free Days in the Prior 2 Weeks
Time Frame: At the 9-month follow-up assessment
|
Number of days without symptoms in the prior 2 weeks
|
At the 9-month follow-up assessment
|
|
Number of Symptom-Free Days in the Prior 2 Weeks
Time Frame: At the 12-month follow-up assessment
|
Number of days without symptoms in the prior 2 weeks
|
At the 12-month follow-up assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: JIll Halterman, MD, MPH, University of Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2016
Primary Completion (Actual)
July 12, 2022
Study Completion (Actual)
July 12, 2022
Study Registration Dates
First Submitted
March 11, 2016
First Submitted That Met QC Criteria
April 22, 2016
First Posted (Estimated)
April 26, 2016
Study Record Updates
Last Update Posted (Estimated)
September 5, 2025
Last Update Submitted That Met QC Criteria
September 3, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60286
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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