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Mail Outreach To Increase Vaccination Acceptance Through Engagement (MOTIVATE)

Primary Purpose

Influenza, Human, Influenza, Human Flu

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Core letter signed by Surgeon General
Core letter signed by the Director of the National Vaccine Program
Core letter signed by Surgeon General + implementation prompt
Core letter signed by SG + enhanced implementation prompt
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza, Human focused on measuring Vaccination, Immunization, Randomized Controlled Trial, Prevention & Control, Preventive Measures, Health Promotion, Medicare, Intention Prompts, Letters

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers
Medicare fee-for-service beneficiaries aged 66 and older are eligible for study inclusion. There will be no additional exclusion criteria.

Sites / Locations

  • Centers for Medicare & Medicaid Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

No letter

Core letter signed by Surgeon General

Core letter signed by Director of the National Vaccine Program

Core letter signed by Surgeon General + implementation prompt

Core letter signed by SG + enhanced implementation prompt

Arm Description

Individuals randomized to the control group who will not receive any of the four letters

Individuals randomized to receive only a core letter signed by the Surgeon General

Individuals randomized to receive only a core letter signed by the Director of the National Vaccine Program

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2014
Last Updated
July 9, 2017
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
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1. Study Identification

Unique Protocol Identification Number
NCT02243774
Brief Title
Mail Outreach To Increase Vaccination Acceptance Through Engagement
Acronym
MOTIVATE
Official Title
Mail Outreach To Increase Vaccination Acceptance Through Engagement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Influenza, Human Flu
Keywords
Vaccination, Immunization, Randomized Controlled Trial, Prevention & Control, Preventive Measures, Health Promotion, Medicare, Intention Prompts, Letters

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No letter
Arm Type
No Intervention
Arm Description
Individuals randomized to the control group who will not receive any of the four letters
Arm Title
Core letter signed by Surgeon General
Arm Type
Experimental
Arm Description
Individuals randomized to receive only a core letter signed by the Surgeon General
Arm Title
Core letter signed by Director of the National Vaccine Program
Arm Type
Experimental
Arm Description
Individuals randomized to receive only a core letter signed by the Director of the National Vaccine Program
Arm Title
Core letter signed by Surgeon General + implementation prompt
Arm Type
Experimental
Arm Description
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
Arm Title
Core letter signed by SG + enhanced implementation prompt
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Core letter signed by Surgeon General
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Core letter signed by the Director of the National Vaccine Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Core letter signed by Surgeon General + implementation prompt
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Core letter signed by SG + enhanced implementation prompt
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of study participants who receive influenza vaccination
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Medicare fee-for-service beneficiaries aged 66 and older are eligible for study inclusion. There will be no additional exclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niteesh K Choudhry, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital/Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centers for Medicare & Medicaid Services
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21244
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Mail Outreach To Increase Vaccination Acceptance Through Engagement

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