Mail Outreach To Increase Vaccination Acceptance Through Engagement (MOTIVATE)

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.

Study Overview

• Status: Completed
• Conditions: Influenza; Influenza, Human; Human Flu
• Intervention / Treatment: Behavioral: Core letter signed by Surgeon General; Behavioral: Core letter signed by the Director of the National Vaccine Program; Behavioral: Core letter signed by Surgeon General + implementation prompt; Behavioral: Core letter signed by SG + enhanced implementation prompt

• Study Type: Interventional
• Enrollment (Actual): 228000
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months

Collaborators and Investigators

• 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
• Investigators: Principal Investigator: Niteesh K Choudhry, MD, PhD, Brigham and Women's Hospital/Harvard Medical School

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 18, 2014

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 9, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Health Promotion; Randomized Controlled Trial; Vaccination; Prevention & Control; Immunization; Medicare; Preventive Measures; Intention Prompts; Letters
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 2014-P-001821