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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEAM-ED Intervention Group | Experimental | Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting |
|
| Enhanced Usual Care | Active Comparator | Report of symptoms to primary care physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEAM-ED | Other | Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JIll Halterman, MD, MPH | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38065280 | Derived | 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. |
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Participants were screened for inclusion/exclusion criteria (age, zip code, asthma severity, reason for emergency visit, foster care, etc.) at the time of the visit to the emergency room. Children were excluded if they did not meet enrollment criteria.
Recruitment occurred in two emergency departments in Rochester, NY in 2016-2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | TEAM-ED Intervention Group | Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting TEAM-ED: Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting |
| FG001 | Enhanced Usual Care | Report of symptoms to primary care physician Enhanced Usual Care: Report of symptoms to primary care physician |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
10 participants were excluded from analysis as we later learned they did not meet the eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | TEAM-ED Intervention Group | Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting TEAM-ED: Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Symptom-Free Days in the Prior 2 Weeks | Number of days without symptoms in the prior 2 weeks | Posted | Mean | Standard Deviation | days | At the 3-month follow-up assessment |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEAM-ED Intervention Group | Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting TEAM-ED: Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Halterman | University of Rochester | 5852755798 | jill_halterman@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2020 | May 30, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2021 | May 30, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Enhanced Usual Care | Other | Report of symptoms to primary care physician |
|
| Lost to Follow-up |
|
| Enhanced Usual Care |
Report of symptoms to primary care physician Enhanced Usual Care: Report of symptoms to primary care physician |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean Symptom-Free Days in prior 2 weeks | Mean | Standard Deviation | days |
|
|
|
| Primary | Number of Symptom-Free Days in the Prior 2 Weeks | Number of days without symptoms in the prior 2 weeks | Posted | Mean | Standard Deviation | days | 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 | Posted | Mean | Standard Deviation | days | 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 | Posted | Mean | Standard Deviation | days | At the 12-month follow-up assessment |
|
|
|
| 0 |
| 185 |
| 0 |
| 185 |
| 0 |
| 185 |
| EG001 | Enhanced Usual Care | Report of symptoms to primary care physician Enhanced Usual Care: Report of symptoms to primary care physician | 0 | 189 | 0 | 189 | 0 | 189 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |