- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03700281
Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019
April 22, 2019 updated by: Eileen Nehme, The University of Texas Health Science Center at Tyler
• This study will assess the effect of promotional messaging and incentives encouraging influenza vaccination in the Sendero IdealCare policy holders during the 2018-2019 Flu Season.
The intervention will consist of influenza vaccination promotion/reminders from Sendero Health Plans to subscribers, including text messages, emails, and tailored direct mail outs, i.e. postcard or a personalized letter, and incentive.
The study population consists of approximately 22,500 subscribers enrolled in Sendero IdealCare Plan.
The intervention will last approximately four months.
The primary endpoints, assessed through administrative claims data, will be getting a flu shot during the 2018-2019 season.
Data collected through this study will be used to determine effective components of influenza vaccination promotion campaigns used by a health insurance plan.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22584
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78701
- The University of Texas System Population Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Enrollment in Sendero IdealCare health plan as of August 1, 2018
- Age 18 years or older
Exclusion Criteria:
- A coverage termination date listed prior to December 31, 2018.
- Sendero member records lack both a phone number and email address.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control
No intervention
|
|
|
EXPERIMENTAL: Messaging
Group will be sent flu vaccine promotion messages via text, email and U.S. Mail
|
The participants will receive influenza promotion emails, text messages, and U.S. mail from Sendero Health Plans.
|
|
EXPERIMENTAL: Messaging plus incentive
Group will be sent flu vaccine promotion messages via text, email and U.S. Mail, and will be eligible to receive a gift card as incentive for receiving flu vaccine
|
The participants will receive influenza promotion emails, text messages, and U.S. mail from Sendero Health Plans.
Participants will be eligible for a gift card to a local grocery store chain as an incentive for obtaining an influenza vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Influenza vaccination
Time Frame: three months
|
Receipt of an influenza vaccination documented by medical or pharmacy claim.
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 6, 2018
Primary Completion (ACTUAL)
March 31, 2019
Study Completion (ANTICIPATED)
August 31, 2019
Study Registration Dates
First Submitted
October 4, 2018
First Submitted That Met QC Criteria
October 4, 2018
First Posted (ACTUAL)
October 9, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 23, 2019
Last Update Submitted That Met QC Criteria
April 22, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SenderoFlu2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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