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出境医 / 临床实验 / Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019

Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019

Study Description
Brief Summary:
• 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.

Condition or disease Intervention/treatment Phase
Influenza, Vaccination Behavioral: Messaging Behavioral: Incentive Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019
Actual Study Start Date : October 6, 2018
Actual Primary Completion Date : March 31, 2019
Estimated Study Completion Date : August 31, 2019
Arms and Interventions
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
Behavioral: Messaging
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
Behavioral: Messaging
The participants will receive influenza promotion emails, text messages, and U.S. mail from Sendero Health Plans.

Behavioral: Incentive
Participants will be eligible for a gift card to a local grocery store chain as an incentive for obtaining an influenza vaccine

Outcome Measures
Primary Outcome Measures :
  1. Influenza vaccination [ Time Frame: three months ]
    Receipt of an influenza vaccination documented by medical or pharmacy claim.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
United States, Texas
The University of Texas System Population Health
Austin, Texas, United States, 78701
Sponsors and Collaborators
The University of Texas Health Science Center at Tyler
Sendero Health Plans, Inc.
Tracking Information
First Submitted Date  ICMJE October 4, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE October 6, 2018
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
Influenza vaccination [ Time Frame: three months ]
Receipt of an influenza vaccination documented by medical or pharmacy claim.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019
Official Title  ICMJE Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019
Brief Summary • 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Influenza, Vaccination
Intervention  ICMJE
  • Behavioral: Messaging
    The participants will receive influenza promotion emails, text messages, and U.S. mail from Sendero Health Plans.
  • Behavioral: Incentive
    Participants will be eligible for a gift card to a local grocery store chain as an incentive for obtaining an influenza vaccine
Study Arms  ICMJE
  • No Intervention: Control
    No intervention
  • Experimental: Messaging
    Group will be sent flu vaccine promotion messages via text, email and U.S. Mail
    Intervention: Behavioral: Messaging
  • 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
    Interventions:
    • Behavioral: Messaging
    • Behavioral: Incentive
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 22, 2019)
22584
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2018)
22500
Estimated Study Completion Date  ICMJE August 31, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03700281
Other Study ID Numbers  ICMJE SenderoFlu2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eileen Nehme, The University of Texas Health Science Center at Tyler
Study Sponsor  ICMJE The University of Texas Health Science Center at Tyler
Collaborators  ICMJE Sendero Health Plans, Inc.
Investigators  ICMJE Not Provided
PRS Account The University of Texas Health Science Center at Tyler
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP