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Mail Outreach To Increase Vaccination Acceptance Through Engagement (MOTIVATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Influenza, Human Influenza Human Flu 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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mail Outreach To Increase Vaccination Acceptance Through Engagement
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   66 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Medicare fee-for-service beneficiaries aged 66 and older are eligible for study inclusion. There will be no additional exclusion criteria.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243774


Locations
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United States, Maryland
Centers for Medicare & Medicaid Services
Baltimore, Maryland, United States, 21244
Sponsors and Collaborators
Brigham and Women's Hospital
Department of Health and Human Services
Centers for Medicare and Medicaid Services
United States Social and Behavioral Sciences Team
Investigators
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Principal Investigator: Niteesh K Choudhry, MD, PhD Brigham and Women's Hospital/Harvard Medical School
More Information
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Responsible Party: Niteesh K. Choudhry, MD, PhD, Associate Professor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02243774    
Other Study ID Numbers: 2014-P-001821
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Keywords provided by Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital:
Vaccination
Immunization
Randomized Controlled Trial
Prevention & Control
Preventive Measures
 Health Promotion
Medicare
Intention Prompts
Letters
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases