Mail Outreach To Increase Vaccination Acceptance Through Engagement

NCT ID: NCT02243774

Last Updated: 2017-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

228000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Influenza, Human Influenza Human Flu

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No letter

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Core letter signed by Surgeon General

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

Group Type EXPERIMENTAL

Core letter signed by Surgeon General

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Core letter signed by the Director of the National Vaccine Program

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Core letter signed by Surgeon General + implementation prompt

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Core letter signed by SG + enhanced implementation prompt

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Medicare fee-for-service beneficiaries aged 66 and older are eligible for study inclusion.

Exclusion Criteria

There will be no additional exclusion criteria.
Minimum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Health and Human Services

FED

Sponsor Role collaborator

Centers for Medicare and Medicaid Services

FED

Sponsor Role collaborator

United States Social and Behavioral Sciences Team

UNKNOWN

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Niteesh K. Choudhry, MD, PhD

Associate Professor, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niteesh K Choudhry, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital/Harvard Medical School

Locations

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Centers for Medicare & Medicaid Services

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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2014-P-001821

Identifier Type: -

Identifier Source: org_study_id

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