School-Based Telemedicine Enhanced Asthma Management (SB-TEAM)
This project aims to improve guideline-based asthma care using enhanced communication and screening tools, telemedicine and directly observed therapy of preventive medications in city schools. Web-based screening will be used to identify children with persistent or poorly controlled asthma and to send reports to the child's primary care doctor. Children in the SB-TEAM group will receive a telemedicine asthma assessment in school and be prescribed a daily preventive asthma medication to be taken through school-based directly observed therapy. The overall aim of this study is to evaluate the use of the SB-TEAM intervention for improving guideline based care, enhancing adherence to effective preventive medications and at reducing morbidity among young urban children with asthma.
Other: School-Based Telemedicine Enhanced Asthma Management
Other: Enhanced Usual Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||School-Based Telemedicine Enhanced Asthma Management: A Randomized Control Trial Using Novel Technology to Improve Preventive Asthma Care|
- Average number of days without asthma symptoms (Symptom Free Days) [ Time Frame: Average number of days, over 2 weeks, during peak winter season (November-March) ] [ Designated as safety issue: No ]The primary outcome measure is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during each follow-up assessment during the peak winter season (November-March). Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath. The number of symptom free days will be reported by the child's caregiver.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Experimental: School-based Telemedicine Enhanced Asthma Mangement Group
We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.
|Other: School-Based Telemedicine Enhanced Asthma Management|
Active Comparator: Enhanced Usual Care Group
Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child's PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group's telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.
|Other: Enhanced Usual Care|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650844
|Contact: Jill S. Halterman, MD, MPHfirstname.lastname@example.org|
|Contact: Maria Fagnano, MPHemail@example.com|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Jill S Halterman, MD, MPH 585-275-7813 firstname.lastname@example.org|
|Principal Investigator: Jill S. Halterman, MD, MPH|