- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06587984
Influenza Reminder Text-Messaging
Influenza Reminder Text-Messaging: A Randomized Quality Improvement Effort to Promote Influenza Vaccine in Pediatric Primary Care
Study Overview
Detailed Description
This is a randomized control trial with two patient cohorts: patients with and without a scheduled well child care visit during the upcoming 2024 flu season. Patients with a scheduled well child visit will be randomized into one of three groups (control, intervention message #1, or intervention message #2). Patients within the intervention groups will receive a one-time text message reminder to get their flu shot for their child at their child's upcoming well visit. Intervention groups will be texted at the same time, the same month as their child's well visit. The text message language will differ between groups. Patients without a scheduled upcoming well child visit during the 2024 flu season will also be randomized into one of three groups (control, intervention message #1, or intervention message #2). Intervention groups will be texted at the same time, at the start of flu season. The text message language will differ between groups.
Flu vaccine uptake will be measured within each patient cohort.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19146
- The Children's Hospital of Philadelphia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients between ages 6 months-18 years old who have an upcoming well visit during the Fall of 2024 (September through December 2024) or had a completed well visit from January 2023 through August 2024
- Patients have a mobile phone number within their medical record
- Patients have opted-in to text communications from CHOP
- English-speaking
Exclusion Criteria:
- Subjects who do not meet the above inclusion criteria will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Cohort 1a
Patients within Cohort 1 have an upcoming well child visit between September-December 2024.
Patients within Cohort 1a are those randomized to CONTROL and will not receive a text message reminder about getting their flu shot at their upcoming visit.
|
|
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Experimental: Cohort 1b
Patients within Cohort 1 have an upcoming well child visit between September-December 2024.
Patients within Cohort 1b are those randomized to INTERVENTION MESSAGE #1 and will receive text message reminder (variation #1) about getting their flu shot at their upcoming visit.
|
One-time text message reminder with information about getting flu vaccine at CHOP
|
|
Experimental: Cohort 1c
Patients within Cohort 1 have an upcoming well child visit between September-December 2024.
Patients within Cohort 1c are those randomized to INTERVENTION MESSAGE #2 and will receive text message reminder (variation #2) about getting their flu shot at their upcoming visit.
|
One-time text message reminder with information about getting flu vaccine at CHOP
|
|
No Intervention: Cohort 2a
Patients within Cohort 2 do not have an upcoming well visit between September-December 2024, but completed their well visit between January 2023 through August 2024.
Patients within Cohort 2a are those randomized to CONTROL and will not receive a text message reminder about getting their flu shot.
|
|
|
Experimental: Cohort 2b
Patients within Cohort 2 do not have an upcoming well visit between September-December 2024, but completed their well visit between January 2023 through August 2024.
Patients within Cohort 2b are those randomized to INTERVENTION MESSAGE #1 and will receive text message reminder (variation #3) about getting their flu shot this upcoming flu season.
|
One-time text message reminder with information about getting flu vaccine at CHOP
|
|
Experimental: Cohort 2c
Patients within Cohort 2 do not have an upcoming well visit between September-December 2024, but completed their well visit between January 2023 through August 2024.
Patients within Cohort 2b are those randomized to INTERVENTION MESSAGE #2 and will receive text message reminder (variation #4) about getting their flu shot this upcoming flu season.
|
One-time text message reminder with information about getting flu vaccine at CHOP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effectiveness of a text message reminder on influenza vaccine uptake
Time Frame: Baseline to approximately 30 days post-text message
|
Via prospective chart review, the primary outcome for both Cohort 1 and Cohort 2 will be to assess the number of patients who received an influenza vaccination 30 days post-text message reminder (baseline).
Data from chart review will determine vaccination status (patient received influenza vaccination or not).
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Baseline to approximately 30 days post-text message
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effectiveness of text message language within Cohort 1
Time Frame: Baseline to approximately 30 days post-text message
|
Via prospective chart review, we will compare the number of patients within the Cohort 1 intervention groups who received influenza vaccination to understand which text message variation was more effective.
Data from chart review will determine vaccination status (patient received influenza vaccination or not).
|
Baseline to approximately 30 days post-text message
|
|
The effectiveness of text message language within Cohort 2
Time Frame: Baseline to approximately 30 days post-text message
|
Via prospective chart review, we will compare the number of patients within the Cohort 2 intervention groups who received influenza vaccination to understand which text message variation was more effective.
Data from chart review will determine vaccination status (patient received influenza vaccination or not).
|
Baseline to approximately 30 days post-text message
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brian P. Jenssen, MD, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-022516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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