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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02752165
Other study ID # 60286
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2016
Est. completion date July 12, 2022

Study information

Verified date June 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 384
Est. completion date July 12, 2022
Est. primary completion date July 12, 2022
Accepts healthy volunteers No
Gender All
Age group 3 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
TEAM-ED
Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting
Enhanced Usual Care
Report of symptoms to primary care physician

Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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