Mail Outreach To Increase Vaccination Acceptance Through Engagement

Influenza Clinical Trial

— MOTIVATE  

Official title:

Mail Outreach To Increase Vaccination Acceptance Through Engagement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243774
• Other study ID #: 2014-P-001821
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: July 9, 2017
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: July 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228000
• Est. completion date: September 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 66 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Flu
• Influenza
• Influenza, Human

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Centers for Medicare & Medicaid Services	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Centers for Medicare and Medicaid Services, Department of Health and Human Services, United States Social and Behavioral Sciences Team

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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