Telemedicine Enhanced Asthma Management Through the Emergency Department (TEAM-ED)
Primary Purpose
Asthma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEAM-ED
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TEAM-ED Intervention Group
Enhanced Usual Care
Arm Description
Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting
Report of symptoms to primary care physician
Outcomes
Primary Outcome Measures
Number of Symptom-Free Days in the prior 2 weeks
Number of days without symptoms in the prior 2 weeks
Number of Symptom-Free Days in the prior 2 weeks
Number of days without symptoms in the prior 2 weeks
Number of Symptom-Free Days in the prior 2 weeks
Number of days without symptoms in the prior 2 weeks
Number of Symptom-Free Days in the prior 2 weeks
Number of days without symptoms in the prior 2 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT02752165
First Posted
March 11, 2016
Last Updated
February 8, 2023
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT02752165
Brief Title
Telemedicine Enhanced Asthma Management Through the Emergency Department
Acronym
TEAM-ED
Official Title
Telemedicine Enhanced Asthma Management Through the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
430 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TEAM-ED Intervention Group
Arm Type
Experimental
Arm Description
Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
Report of symptoms to primary care physician
Intervention Type
Other
Intervention Name(s)
TEAM-ED
Intervention Description
Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Report of symptoms to primary care physician
Primary Outcome Measure Information:
Title
Number of Symptom-Free Days in the prior 2 weeks
Description
Number of days without symptoms in the prior 2 weeks
Time Frame
At the 3-month follow-up assessment
Title
Number of Symptom-Free Days in the prior 2 weeks
Description
Number of days without symptoms in the prior 2 weeks
Time Frame
At the 6-month follow-up assessment
Title
Number of Symptom-Free Days in the prior 2 weeks
Description
Number of days without symptoms in the prior 2 weeks
Time Frame
At the 9-month follow-up assessment
Title
Number of Symptom-Free Days in the prior 2 weeks
Description
Number of days without symptoms in the prior 2 weeks
Time Frame
At the 12-month follow-up assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIll Halterman, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Telemedicine Enhanced Asthma Management Through the Emergency Department
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