NCT02752165

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

December 15, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 12, 2024

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

5.6 years

First QC Date

March 11, 2016

Results QC Date

June 12, 2023

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Number of Symptom-Free Days in the Prior 2 Weeks

    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

    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

    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

    Number of days without symptoms in the prior 2 weeks

    At the 12-month follow-up assessment

Study Arms (2)

TEAM-ED Intervention Group

EXPERIMENTAL

Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting

Other: TEAM-ED

Enhanced Usual Care

ACTIVE COMPARATOR

Report of symptoms to primary care physician

Other: Enhanced Usual Care

Interventions

TEAM-EDOTHER

Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting

TEAM-ED Intervention Group

Report of symptoms to primary care physician

Enhanced Usual Care

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Halterman JS, Fagnano M, Tremblay P, Butz A, Perry TT, Wang H. Effect of the Telemedicine Enhanced Asthma Management Through the Emergency Department (TEAM-ED) Program on Asthma Morbidity: A Randomized Controlled Trial. J Pediatr. 2024 Mar;266:113867. doi: 10.1016/j.jpeds.2023.113867. Epub 2023 Dec 6.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Jill Halterman
Organization
University of Rochester

Study Officials

  • JIll Halterman, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2016

First Posted

April 26, 2016

Study Start

December 15, 2016

Primary Completion

July 12, 2022

Study Completion

July 12, 2022

Last Updated

September 5, 2025

Results First Posted

February 12, 2024

Record last verified: 2025-09

Locations