CClinicalTrials.gg
CompletedNCT02243774MOTIVATEUpdated Jul 12, 2017

Mail Outreach To Increase Vaccination Acceptance Through Engagement

An interventional study of Core letter signed by Surgeon General and Core letter signed by the Director of the National Vaccine Program in Influenza, Human, Influenza and Human Flu, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 66 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-12.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
228,000
Allocation
Randomized
Ages
66 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Influenza, Human
  • Influenza
  • Human Flu

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Keywords

  • Vaccination
  • Immunization
  • Randomized Controlled Trial
  • Prevention & Control
  • Preventive Measures
  • Health Promotion
  • Medicare
  • Intention Prompts
  • Letters
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 228,000 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
66 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Medicare fee-for-service beneficiaries aged 66 and older are eligible for study inclusion. There will be no additional exclusion criteria.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
228,000 participants (actual)

Study arms

  • 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

    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

    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

    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

    Behavioral: Core letter signed by SG + enhanced implementation prompt

Interventions

  • BehavioralCore 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.

  • BehavioralCore 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.

  • BehavioralCore 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.

  • BehavioralCore 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.

06

What researchers measure

Primary outcomes

  1. Number of study participants who receive influenza vaccination

    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

    Time frame: 4 months

07

Study locations

1 site
  • Centers for Medicare & Medicaid Services
    Baltimore, Maryland 21244, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02243774
Lead sponsor
Brigham and Women's Hospital
Collaborators
Department of Health and Human Services, Centers for Medicare and Medicaid Services, United States Social and Behavioral Sciences Team
Responsible party
Niteesh K. Choudhry, MD, PhD (Associate Professor, Harvard Medical School, Brigham and Women's Hospital) — Principal investigator
First posted
Sep 18, 2014
Start date
Sep 2014
Primary completion
Jan 2015
Completion
Sep 2015
Last update
Jul 12, 2017

Study contacts

Niteesh K Choudhry, MD, PhD
principal investigator · Brigham and Women's Hospital/Harvard Medical School
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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