NCT02243774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

September 16, 2014

Last Update Submit

July 9, 2017

Conditions

Keywords

VaccinationImmunizationRandomized Controlled TrialPrevention & ControlPreventive MeasuresHealth PromotionMedicareIntention PromptsLetters

Outcome Measures

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

    4 months

Study Arms (5)

No letter

NO INTERVENTION

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

Core letter signed by Surgeon General

EXPERIMENTAL

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

Behavioral: Core letter signed by Surgeon General

Core letter signed by Director of the National Vaccine Program

EXPERIMENTAL

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

Core letter signed by Surgeon General + implementation prompt

EXPERIMENTAL

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

Core letter signed by SG + enhanced implementation prompt

EXPERIMENTAL

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

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 Surgeon General

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 Director of the National Vaccine Program

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 Surgeon General + 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.

Core letter signed by SG + enhanced implementation prompt

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centers for Medicare & Medicaid Services

Baltimore, Maryland, 21244, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Niteesh K Choudhry, MD, PhD

    Brigham and Women's Hospital/Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Harvard Medical School

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 18, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2015

Study Completion

September 1, 2015

Last Updated

July 12, 2017

Record last verified: 2017-07

Locations