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Mail Outreach To Increase Vaccination Acceptance Through Engagement (MOTIVATE)

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ClinicalTrials.gov Identifier: NCT02243774
Recruitment Status : Completed
First Posted : September 18, 2014
Last Update Posted : July 12, 2017
Sponsor:
Collaborators:
Department of Health and Human Services
Centers for Medicare and Medicaid Services
United States Social and Behavioral Sciences Team
Information provided by (Responsible Party):
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE September 16, 2014
First Posted Date  ICMJE September 18, 2014
Last Update Posted Date July 12, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2017)
Number of study participants who receive influenza vaccination [ Time Frame: 4 months ]
Primary outcome of interest, determined from administrative claims data, will be the number of beneficiaries in each experimental group who receive an influenza vaccination between the date letter is mailed in September 2014 and January 31, 2015
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2014)
Number of study participants who receive influenza vaccination [ Time Frame: 4 months ]
Primary outcome of interest, determined from administrative claims data, will be the number of beneficiaries in each experimental group who receive an influenza vaccination between the date letter is mailed in September 2014 and December 31, 2014
Change History Complete list of historical versions of study NCT02243774 on ClinicalTrials.gov Archive Site
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 Mail Outreach To Increase Vaccination Acceptance Through Engagement
Official Title  ICMJE Mail Outreach To Increase Vaccination Acceptance Through Engagement
Brief Summary The aim of this study is to determine whether receiving a core letter signed by the Surgeon General or the Director of the National Vaccine Program that provides only information about influenza, or a core letter signed by the Surgeon General with an added basic or enhanced implementation prompt, will increase rates of influenza vaccination among Medicare beneficiaries when compared to a control group.
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: Treatment
Condition  ICMJE
  • Influenza, Human
  • Influenza
  • Human Flu
Intervention  ICMJE
  • Behavioral: Core letter signed by Surgeon General
    The core letter provides information about influenza and the risks associated with it, incorporating a number of behavioral insights. All four letters evaluated in this study will contain the same tops and bodies that are included in the core letter, but the signature and P.S. tag region will differ among the various intervention groups. In this intervention, the core letter is signed by and includes a picture of the Surgeon General. The letter ends after the signature line and the space beneath the signature line is left blank where a P.S. tag region could be appended.
  • Behavioral: Core letter signed by the Director of the National Vaccine Program
    The core letter is signed by and includes a picture of the Director of the National Vaccine Program. The letter ends after the signature line and the space beneath the signature line is left blank where a P.S. tag region could be appended.
  • Behavioral: Core letter signed by Surgeon General + implementation prompt
    The core letter is signed by and includes a picture of the Surgeon General. Below the signature line of the core letter, an implementation intention prompt is provided in the P.S. tag region that invites the recipient to write in the day of week, month, day, and time at which he or she plans to get vaccinated.
  • Behavioral: Core letter signed by SG + enhanced implementation prompt
    The core letter is signed by and includes a picture of the Surgeon General (SG). Below the signature line of the core letter, an enhanced implementation intention prompt is provided in the P.S. tag region that prompts recipients to "decide now" - by checking one of two boxes - indicating they will or will not get vaccinated. The options use language that highlights the losses incumbent in refusing to vaccinate. In addition, an implementation intention prompt is embedded into the checkbox for indicating a choice to be vaccinated.
Study Arms  ICMJE
  • No Intervention: No letter
    Individuals randomized to the control group who will not receive any of the four letters
  • Experimental: Core letter signed by Surgeon General
    Individuals randomized to receive only a core letter signed by the Surgeon General
    Intervention: Behavioral: Core letter signed by Surgeon General
  • Experimental: Core letter signed by Director of the National Vaccine Program
    Individuals randomized to receive only a core letter signed by the Director of the National Vaccine Program
    Intervention: Behavioral: Core letter signed by the Director of the National Vaccine Program
  • Experimental: Core letter signed by Surgeon General + implementation prompt
    Individuals randomized to receive a core letter signed by the Surgeon General with an implementation intention prompt added in an appended P.S. tag region below the signature line
    Intervention: Behavioral: Core letter signed by Surgeon General + implementation prompt
  • Experimental: Core letter signed by SG + enhanced implementation prompt
    Individuals randomized to receive a core letter signed by the Surgeon General (SG) with an enhanced implementation intention prompt added in an appended P.S. tag region below the signature line
    Intervention: Behavioral: Core letter signed by SG + enhanced implementation prompt
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2014)
228000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Medicare fee-for-service beneficiaries aged 66 and older are eligible for study inclusion. There will be no additional exclusion criteria.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 66 Years and older   (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 NCT02243774
Other Study ID Numbers  ICMJE 2014-P-001821
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE
  • Department of Health and Human Services
  • Centers for Medicare and Medicaid Services
  • United States Social and Behavioral Sciences Team
Investigators  ICMJE
Principal Investigator: Niteesh K Choudhry, MD, PhD Brigham and Women's Hospital/Harvard Medical School
PRS Account Brigham and Women's Hospital
Verification Date July 2017

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