Influenza, HumanMOTIVATENCT02243774
Mail Outreach To Increase Vaccination Acceptance Through Engagement
A study testing Core letter signed by Surgeon General, Core letter signed by the Director of the National Vaccine Program and Core letter signed by Surgeon General + implementation prompt in people with Influenza, Human and Influenza, run by Brigham and Women's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 66 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Influenza, Human Flu
- What is being tested?
- Core letter signed by Surgeon General, Core letter signed by the Director of the National Vaccine Program and Core letter signed by Surgeon General + implementation prompt
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Medicare fee-for-service beneficiaries aged 66 and older are eligible for study inclusion. There will be no additional exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Centers for Medicare & Medicaid Services
Baltimore, Maryland, 21244
About this study
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.
- Conditions
- Influenza, Human, Influenza, Human Flu
- Being tested
- Core letter signed by Surgeon General, Core letter signed by the Director of the National Vaccine Program, Core letter signed by Surgeon General + implementation prompt, Core letter signed by SG + enhanced implementation prompt
- Keywords
- Vaccination, Immunization, Randomized Controlled Trial, Prevention & Control, Preventive Measures, Health Promotion, Medicare, Intention Prompts, Letters
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core letter signed by Surgeon GeneralBehavioural
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 ProgramBehavioural
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 promptBehavioural
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 promptBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Core letter signed by SG + enhanced implementation prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Centers for Medicare and Medicaid Services, United States Social and Behavioral Sciences Team
- Responsible party
- Principal investigator, Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
- Investigators
- Niteesh K Choudhry, MD, PhD, Principal investigator, Brigham and Women's Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243774
- Sponsor's protocol ID
- 2014-P-001821
- Acronym
- MOTIVATE
- Status last verified
- Jul 2017
- First submitted
- 16 Sep 2014
- Last updated
- 12 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mail Outreach To Increase Vaccination Acceptance Through Engagement
- ClinicalTrials.gov ID
- NCT02243774
- Acronym / sponsor ID
- MOTIVATE / 2014-P-001821
- Conditions
- Influenza, Human, Influenza, Human Flu
- Keywords
- Vaccination, Immunization, Randomized Controlled Trial, Prevention & Control, Preventive Measures, Health Promotion, Medicare, Intention Prompts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228,000 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Centers for Medicare and Medicaid Services, United States Social and Behavioral Sciences Team
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Core letter signed by Surgeon GeneralIndividuals randomized to receive only a core letter signed by the Surgeon General |
| Core letter signed by Director of the National Vaccine Program | Experimental | Behavioral: Core letter signed by the Director of the National Vaccine ProgramIndividuals randomized to receive only a core letter signed by the Director of the National Vaccine Program |
| Core letter signed by Surgeon General + implementation prompt | Experimental | Behavioral: Core letter signed by Surgeon General + implementation promptIndividuals 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 |
| Core letter signed by SG + enhanced implementation prompt | Experimental | Behavioral: Core letter signed by SG + enhanced implementation promptIndividuals 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 |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core letter signed by Surgeon GeneralThe 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. | Behavioural | Core letter signed by Surgeon General |
| Core letter signed by the Director of the National Vaccine ProgramThe 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. | Behavioural | Core letter signed by Director of the National Vaccine Program |
| Core letter signed by Surgeon General + implementation promptThe 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. | Behavioural | Core letter signed by Surgeon General + implementation prompt |
| Core letter signed by SG + enhanced implementation promptThe 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. | Behavioural | Core letter signed by SG + enhanced implementation prompt |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niteesh K Choudhry, MD, PhD principal investigator
Brigham and Women's Hospital/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core letter signed by Surgeon General, Core letter signed by the Director of the National Vaccine Program and Core letter signed by Surgeon General + implementation prompt in people with Influenza, Human and Influenza, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of study participants who receive influenza vaccination (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.