Telemedicine Enhanced Asthma Management - Uniting Providers

Study Overview
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Brief Summary
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This research study is an innovative school-based program for urban children with moderate to severe persistent or difficult-to-control asthma. The Telemedicine Enhanced Asthma Management-Uniting Providers (TEAM-UP) program enhances a school-based, primary care directed asthma program with specialist-supported care to ensure optimal guideline based treatment. This study is a full-scale randomized trial of TEAM-UP versus an enhanced care comparison group. Primary care physicians (PCP) of all enrolled children (n=360, 4-12 yrs.) will be prompted to initiate directly observed therapy (DOT) of preventive asthma medication through school and to make a specialist referral. For children in the TEAM-UP group, the specialist visits will be facilitated via telemedicine at school. The telemedicine specialist visit will be scheduled after 4 weeks of initiating DOT, in order to allow for accurate guideline-based assessments of medication and care needs once adherence with a daily controller medication is established. There will also be 2 telemedicine follow-up specialist visits to assess the child's response to treatment and make needed adjustments. The study will use the existing community infrastructure by implementing both telemedicine and DOT in school, and maintaining collaboration with PCPs. Blinded follow-ups will occur at 3-, 6-, 9- and 12-months after baseline, and the primary outcome is the comparison of symptom-free days (SFD) at each follow-up time point.

Official Title
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Telemedicine Enhanced Asthma Management - Uniting Providers

Conditions
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Asthma in Children

Intervention / Treatment
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* Other: TEAM-UP Intervention Group
* Other: Enhanced Care Comparison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician-diagnosed asthma (based on parent report with validation from the child's physician). Age >=4 and =<12 years. Residence in the City of Rochester and surrounding suburbs, with a. primary residence within the following zip codes: 14445, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14620, 14621, 14622, 14623, 14624, 14625, 14626. Moderate-severe persistent severity (requiring Step 3 or higher care) or difficult to control asthma despite therapy (based on age-specific NHLBI guidelines). Exclusion Criteria: Inability to speak and understand English or Spanish. (*Parents unable to read will be eligible, and all instruments will be given verbally.) Current participation in an asthma study. Planning to leave the Rochester city school district area in fewer than 6 months. Having received asthma specialist care in the prior 3 months. Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. In foster care or other situations in which consent cannot be obtained from a guardian.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEAM-UP Intervention Group<br> | Other: TEAM-UP Intervention Group<br>* Children randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after 4 weeks of initiating DOT at school, as well as 2 subsequent follow-up visits. The visits will be performed by a specialist in pediatric asthma, to implement guideline-based care. Prescriptions for asthma medications will be prescribed to be delivered as directly observed therapy in school.<br>|
| Active Comparator: Enhanced Care Comparison Group<br> | Other: Enhanced Care Comparison<br>* Similar to the TEAM-UP group, children in the Enhanced Care group will receive a symptom assessment and asthma education materials at baseline, and we will contact the PCP by facsimile or email and will recommend DOT of preventive asthma medication through school as well as a referral to specialist. However specialist visits will not be facilitated via telemedicine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Symptom-Free Days in prior 14 days | Mean number of symptom-free days in the prior 14 days (range 0-14) | 3 months after baseline | 
| Mean Symptom-Free Days in prior 14 days | Mean number of symptom-free days in the prior 14 days (range 0-14) | 6 months after baseline | 
| Mean Symptom-Free Days in prior 14 days | Mean number of symptom-free days in the prior 14 days (range 0-14) | 9 months after baseline | 
| Mean Symptom-Free Days in prior 14 days | Mean number of symptom-free days in the prior 14 days (range 0-14) | 12 months after baseline |