An interventional study of TEAM-ED and Enhanced Usual Care in Asthma, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 384 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Exclusion Criteria:
Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting
Other: TEAM-ED
Report of symptoms to primary care physician
Other: Enhanced Usual Care
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
Number of Symptom-Free Days in the Prior 2 Weeks
Number of days without symptoms in the prior 2 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the 12-month follow-up assessment
Recruitment occurred in two emergency departments in Rochester, NY in 2016-2021.
| Milestone | TEAM-ED Intervention Group | Enhanced Usual Care |
|---|---|---|
| Started | 191 | 193 |
| Completed | 146 | 144 |
| Not completed | 45 | 49 |
| Withdrew: Withdrawal by subject | 6 | 6 |
| Withdrew: Protocol violation | 6 | 5 |
| Withdrew: Lost to follow-up | 33 | 38 |
Number of days without symptoms in the prior 2 weeks
| days | TEAM-ED Intervention Group | Enhanced Usual Care |
|---|---|---|
| Number of Symptom-Free Days in the Prior 2 Weeks | 9.5 ± 4.9 | 10.1 ± 4.6 |
Number of days without symptoms in the prior 2 weeks
| days | TEAM-ED Intervention Group | Enhanced Usual Care |
|---|---|---|
| Number of Symptom-Free Days in the Prior 2 Weeks | 10.2 ± 4.6 | 10.4 ± 4.3 |
Number of days without symptoms in the prior 2 weeks
| days | TEAM-ED Intervention Group | Enhanced Usual Care |
|---|---|---|
| Number of Symptom-Free Days in the Prior 2 Weeks | 10.4 ± 4.6 | 10.5 ± 4.3 |
Number of days without symptoms in the prior 2 weeks
| days | TEAM-ED Intervention Group | Enhanced Usual Care |
|---|---|---|
| Number of Symptom-Free Days in the Prior 2 Weeks | 10.3 ± 4.8 | 10.0 ± 4.7 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TEAM-ED Intervention Group | 0/185 (0%) | 0/185 (0%) | 0/185 (0%) |
| Enhanced Usual Care | 0/189 (0%) | 0/189 (0%) | 0/189 (0%) |
10 participants were excluded from analysis as we later learned they did not meet the eligibility criteria.
| Age, Continuous(years) | TEAM-ED Intervention Group | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 6.3 ± 2.6 | 6.5 ± 1.8 | 6.4 ± 2.7 |
| Sex: Female, Male(Participants) | TEAM-ED Intervention Group | Enhanced Usual Care | Total |
|---|---|---|---|
| Female | 74 | 75 | 149 |
| Male | 111 | 113 | 224 |
| Ethnicity (NIH/OMB)(Participants) | TEAM-ED Intervention Group | Enhanced Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 64 | 57 | 121 |
| Not Hispanic or Latino | 121 | 131 | 252 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | TEAM-ED Intervention Group | Enhanced Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 94 | 106 | 200 |
| White | 17 | 15 | 32 |
| More than one race | 30 | 32 | 62 |
| Unknown or Not Reported | 40 | 33 | 73 |
| Region of Enrollment(participants) | TEAM-ED Intervention Group | Enhanced Usual Care | Total |
|---|---|---|---|
| United States | 185 | 188 | 373 |
| Mean Symptom-Free Days in prior 2 weeks(days) | TEAM-ED Intervention Group | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 6.61 ± 4.9 | 6.88 ± 4.6 | 6.7 ± 4.8 |
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