Asthma
Conditions
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.
Interventions
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
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Symptom-Free Days in the Prior 2 Weeks | At the 3-month follow-up assessment | Number of days without symptoms in the prior 2 weeks |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred in two emergency departments in Rochester, NY in 2016-2021.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 185 |
| Enhanced Usual Care Report of symptoms to primary care physician
Enhanced Usual Care: Report of symptoms to primary care physician | 188 |
| Total | 373 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 33 | 38 |
| Overall Study | Protocol Violation | 6 | 5 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | Total | TEAM-ED Intervention Group | Enhanced Usual Care |
|---|---|---|---|
| Age, Continuous | 6.4 years STANDARD_DEVIATION 2.7 | 6.3 years STANDARD_DEVIATION 2.6 | 6.5 years STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 121 Participants | 64 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 252 Participants | 121 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mean Symptom-Free Days in prior 2 weeks | 6.7 days STANDARD_DEVIATION 4.8 | 6.61 days STANDARD_DEVIATION 4.9 | 6.88 days STANDARD_DEVIATION 4.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 200 Participants | 94 Participants | 106 Participants |
| Race (NIH/OMB) More than one race | 62 Participants | 30 Participants | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 73 Participants | 40 Participants | 33 Participants |
| Race (NIH/OMB) White | 32 Participants | 17 Participants | 15 Participants |
| Region of Enrollment United States | 373 participants | 185 participants | 188 participants |
| Sex: Female, Male Female | 149 Participants | 74 Participants | 75 Participants |
| Sex: Female, Male Male | 224 Participants | 111 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 185 | 0 / 189 |
| other Total, other adverse events | 0 / 185 | 0 / 189 |
| serious Total, serious adverse events | 0 / 185 | 0 / 189 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEAM-ED Intervention Group | Number of Symptom-Free Days in the Prior 2 Weeks | 9.5 days | Standard Deviation 4.9 |
| Enhanced Usual Care | Number of Symptom-Free Days in the Prior 2 Weeks | 10.1 days | Standard Deviation 4.6 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEAM-ED Intervention Group | Number of Symptom-Free Days in the Prior 2 Weeks | 10.2 days | Standard Deviation 4.6 |
| Enhanced Usual Care | Number of Symptom-Free Days in the Prior 2 Weeks | 10.4 days | Standard Deviation 4.3 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEAM-ED Intervention Group | Number of Symptom-Free Days in the Prior 2 Weeks | 10.4 days | Standard Deviation 4.6 |
| Enhanced Usual Care | Number of Symptom-Free Days in the Prior 2 Weeks | 10.5 days | Standard Deviation 4.3 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEAM-ED Intervention Group | Number of Symptom-Free Days in the Prior 2 Weeks | 10.3 days | Standard Deviation 4.8 |
| Enhanced Usual Care | Number of Symptom-Free Days in the Prior 2 Weeks | 10.0 days | Standard Deviation 4.7 |