- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02436070
Use of Text Messages to Improve Care For Children Following an ED Visit for Asthma
BACKGROUND Asthma is a prevalent and troublesome pediatric condition. In 2013, Emergency Department (ED) providers treated over 3,500 cases of asthma-related complaints at Children's Hospitals and Clinics of Minnesota. Pediatric ED visits for asthma exceeds billions of dollars annually when including direct cost and lost productivity. Many of these visits and resultant costs are avoidable. Patients with well-controlled asthma do not typically exhibit these patterns, while patients with poorly controlled asthma show patterns of increased utilization of healthcare resources and lower quality of life. Evidence suggests that a text message reminder and educational program might positively influence pediatric asthma care practices.
RESEARCH QUESTION Does a targeted ED based text message intervention program improve outpatient follow-up and routine preventive care in pediatric asthma patients?
METHODS Study subjects will be block randomized based on age and insurance group. The experimental group will receive text messages with guidance towards follow-up care with their PCP and the importance of the flu vaccine for children with asthma. The control group will receive a series of educational self-care and health based text messages unrelated to asthma or the flu vaccine. Some self-report of behaviors will be captured via text message response.
ANALYSIS Primary outcomes for the educational versus targeted text message groups will be compared use Chi-square tests. Additional adjustments may be applied for missing data or if, despite randomization, there is substantial imbalance between group in key covariates (eg race/ethnicity, insurance type or asthma severity.)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55404
- Recruiting
- Children's Hospitals and Clinics of Minnesota - Emergency Department
-
Contact:
- Anupam B Kharbanda, MD
-
Saint Paul, Minnesota, United States
- Recruiting
- Children's Minnesota
-
Contact:
- Anupam Kharbanda, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Caregivers of patients aged 4 - 17 years (inclusive) will be eligible for study participation if they meet the following criteria:
- Presentation to the ED with a chief complaint related to an asthma exacerbation such as shortness of breath, respiratory distress, wheezing, etc…
- Receive an albuterol treatment in the ED
- Previous history of asthma as represented in the medical record or by parental report
- Have a cell phone that is able to receive text messages
- Able to communicate and provide consent in English or Spanish
Exclusion Criteria:
Caregivers of patients will be excluded from this study for the following reasons:
- First episode of wheezing
- Admitted to the hospital
Co-morbid respiratory disease:
- Cystic fibrosis
- Bronchiectasis
- Pulmonary hypertension
- Other chronic lung disease
- Current cancer diagnosis
- Previous cardiovascular surgery
- Inflammatory bowel disease
- Sickle Cell disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Subjects receive general, health-related text messages applicable for children with asthma.
|
Subjects received text messages generalized to children with asthma
|
|
Experimental: Test group
Subjects receive specific, targeted text messages for post-emergency department discharge asthma care.
|
Subjects received text messages specific to post ED asthma follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Follow-up care with primary care provider
Time Frame: 1 week after emergency department discharge
|
Assessed via text and follow-up call if no response to text message
|
1 week after emergency department discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Influenza vaccine
Time Frame: 30 days after emergency department discharge
|
Assessed via text and follow-up call if no response to text message
|
30 days after emergency department discharge
|
|
Return visit to the emergency department
Time Frame: 30 days after the inaugural emergency department visit
|
Assessed via text and follow-up call if no response to text message; Our health record also checked for return visits
|
30 days after the inaugural emergency department visit
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1409-082
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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