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Use of Text Messages to Improve Care For Children Following an ED Visit for Asthma

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted text messages
General text messages
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Pediatrics, Emergency Medicine, Text messaging

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Caregivers of patients aged 4 - 17 years (inclusive) will be eligible for study participation if they meet the following criteria:

    1. Presentation to the ED with a chief complaint related to an asthma exacerbation such as shortness of breath, respiratory distress, wheezing, etc…
    2. Receive an albuterol treatment in the ED
    3. Previous history of asthma as represented in the medical record or by parental report
    4. Have a cell phone that is able to receive text messages
    5. 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:

    1. First episode of wheezing
    2. Admitted to the hospital
    3. Co-morbid respiratory disease:

      1. Cystic fibrosis
      2. Bronchiectasis
      3. Pulmonary hypertension
      4. Other chronic lung disease
    4. Current cancer diagnosis
    5. Previous cardiovascular surgery
    6. Inflammatory bowel disease
    7. Sickle Cell disease

Sites / Locations

  • Children's Hospitals and Clinics of Minnesota - Emergency DepartmentRecruiting
  • Children's MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Test group

Arm Description

Subjects receive general, health-related text messages applicable for children with asthma.

Subjects receive specific, targeted text messages for post-emergency department discharge asthma care.

Outcomes

Primary Outcome Measures

Follow-up care with primary care provider
Assessed via text and follow-up call if no response to text message

Secondary Outcome Measures

Influenza vaccine
Assessed via text and follow-up call if no response to text message
Return visit to the emergency department
Assessed via text and follow-up call if no response to text message; Our health record also checked for return visits

Full Information

First Posted
May 1, 2015
Last Updated
November 20, 2017
Sponsor
Children's Hospitals and Clinics of Minnesota
Collaborators
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02436070
Brief Title
Use of Text Messages to Improve Care For Children Following an ED Visit for Asthma
Official Title
Use of Text Messages to Improve Care For Children Following an ED Visit for Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota
Collaborators
HealthPartners Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Pediatrics, Emergency Medicine, Text messaging

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects receive general, health-related text messages applicable for children with asthma.
Arm Title
Test group
Arm Type
Experimental
Arm Description
Subjects receive specific, targeted text messages for post-emergency department discharge asthma care.
Intervention Type
Behavioral
Intervention Name(s)
Targeted text messages
Intervention Description
Subjects received text messages specific to post ED asthma follow-up
Intervention Type
Behavioral
Intervention Name(s)
General text messages
Intervention Description
Subjects received text messages generalized to children with asthma
Primary Outcome Measure Information:
Title
Follow-up care with primary care provider
Description
Assessed via text and follow-up call if no response to text message
Time Frame
1 week after emergency department discharge
Secondary Outcome Measure Information:
Title
Influenza vaccine
Description
Assessed via text and follow-up call if no response to text message
Time Frame
30 days after emergency department discharge
Title
Return visit to the emergency department
Description
Assessed via text and follow-up call if no response to text message; Our health record also checked for return visits
Time Frame
30 days after the inaugural emergency department visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Vander Velden
Phone
6128137892
Email
heidi.vandervelden@childrensmn.org
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota - Emergency Department
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anupam B Kharbanda, MD
Facility Name
Children's Minnesota
City
Saint Paul
State/Province
Minnesota
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anupam Kharbanda, MD

12. IPD Sharing Statement

Learn more about this trial

Use of Text Messages to Improve Care For Children Following an ED Visit for Asthma

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