COVID-19 ImmunisationNCT06646406
Evaluation of a Multilevel Intervention on Adult COVID-19 and Influenza Vaccination Rate
A study testing Patient letter and clinician communication in people with COVID-19 Immunisation and Influenza Vaccine, run by Mayo Clinic at 2 sites in United States.
Trial summary
The study will test two tactics to improve uptake of two vaccines in adults. The vaccines prevent COVID-19 and influenza. Both are common and harmful. Most adults do not get either vaccine. This is despite strong recommendations that all adults get both vaccines. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Immunisation, Influenza Vaccine
- What is being tested?
- Patient letter and clinician communication
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114,165 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2024to 30 Apr 2025
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 19 years and older
- Patients empaneled to 1 of 8 adult primary care practices as of September 2024
Who cannot join
- Patients 18 years or younger
- Patients not empaneled to 1 of 8 adult primary care practices as of September 2024
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55902
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The study will test two tactics to improve uptake of two vaccines in adults. The vaccines prevent COVID-19 and influenza. Both are common and harmful. Most adults do not get either vaccine. This is despite strong recommendations that all adults get both vaccines.
The study will involve adult patients at eight Mayo Clinic primary care practices in Rochester and Kasson. The study will test the two tactics together. Four clinics will get the two tactics. The other four clinics will not. The study will randomly assign the two tactics to the clinics. One tactic is to send a letter by US mail to the patient. The letter will state strong recommendations on getting both vaccines now. It will tell patients how to get the vaccines now. The second tactic is to send monthly emails to clinicians. It will remind them to use every visit to vaccinate patients against COVID-19 and influenza. The study will compare the uptake of the two vaccines after six months in the clinics with and without the two tactics.
- Conditions
- COVID-19 Immunisation, Influenza Vaccine
- Being tested
- Patient letter and clinician communication
- Keywords
- Adult, Vaccination, Influenza vaccines, COVID-19 Vaccines, Primary Health Care, Reminder Systems, Clinician communication, Patient communication
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient letter and clinician communicationBehavioural
Also called Reminder systems, Clinician communication
Single mailing to patients from practice with a reminder that the influenza and COVID-19 vaccines are due, and monthly emailing to the patients' clinicians with information about how to make a strong recommendation for those vaccines
| Study group | Role | What they receive |
|---|---|---|
| Patient letter and clinician communication | Experimental | Each patient will be mailed a letter and each patient's clinician will receive a monthly email communicating information about making a strong recommendation for influenza and COVID-19 vaccination Receives: Behavioral: Patient letter and clinician communication |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 vaccine uptake
Rates of at least one dose of single licensed 2024-2025 COVID-19 vaccine among adult patients at eight Mayo Clinic primary care practices
Measured: 7.5 months
Influenza vaccine uptake
Rates of at least one dose of single licensed 2024-2025 trivalent influenza vaccine among adult patients at eight Mayo Clinic primary care practices
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start21 Oct 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 ImmunisationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114,165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- ModernaTX, Inc.
- Responsible party
- Principal investigator, Lila J. Rutten, Mayo Clinic
- Investigators
- Lila J. Rutten, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646406
- Sponsor's protocol ID
- 24-007738
- Status last verified
- Jul 2025
- First submitted
- 30 Sep 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multilevel Intervention on Adult COVID-19 and Influenza Vaccination Rate
- ClinicalTrials.gov ID
- NCT06646406
- Acronym / sponsor ID
- 24-007738
- Conditions
- COVID-19 Immunisation, Influenza Vaccine
- Keywords
- Adult, Vaccination, Influenza vaccines, COVID-19 Vaccines, Primary Health Care, Reminder Systems, Clinician communication, Patient communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114,165 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- ModernaTX, Inc.
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 17 Oct 2024 (actual)
- 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 study will test two tactics to improve uptake of two vaccines in adults. The vaccines prevent COVID-19 and influenza. Both are common and harmful. Most adults do not get either vaccine. This is despite strong recommendations that all adults get both vaccines.
The study will involve adult patients at eight Mayo Clinic primary care practices in Rochester and Kasson. The study will test the two tactics together. Four clinics will get the two tactics. The other four clinics will not. The study will randomly assign the two tactics to the clinics. One tactic is to send a letter by US mail to the patient. The letter will state strong recommendations on getting both vaccines now. It will tell patients how to get the vaccines now. The second tactic is to send monthly emails to clinicians. It will remind them to use every visit to vaccinate patients against COVID-19 and influenza. The study will compare the uptake of the two vaccines after six months in the clinics with and without the two tactics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient letter and clinician communication | Experimental | Behavioral: Patient letter and clinician communicationEach patient will be mailed a letter and each patient's clinician will receive a monthly email communicating information about making a strong recommendation for influenza and COVID-19 vaccination |
| No intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 19 years and older
- Patients empaneled to 1 of 8 adult primary care practices as of September 2024
Key exclusion criteria (2 listed)
- Patients 18 years or younger
- Patients not empaneled to 1 of 8 adult primary care practices as of September 2024
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 |
|---|---|---|
| Patient letter and clinician communicationAlso: Reminder systems, Clinician communicationSingle mailing to patients from practice with a reminder that the influenza and COVID-19 vaccines are due, and monthly emailing to the patients' clinicians with information about how to make a strong recommendation for those vaccines | Behavioural | Patient letter and clinician communication |
Primary outcome
COVID-19 vaccine uptake
Time frame: 7.5 months
Rates of at least one dose of single licensed 2024-2025 COVID-19 vaccine among adult patients at eight Mayo Clinic primary care practices
Influenza vaccine uptake
Time frame: 9 months
Rates of at least one dose of single licensed 2024-2025 trivalent influenza vaccine among adult patients at eight Mayo Clinic primary care practices
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 5 Aug 2025.
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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.
Lila J. Rutten, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient letter and clinician communication in people with COVID-19 Immunisation and Influenza Vaccine, run by Mayo Clinic at 2 sites 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?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
COVID-19 vaccine uptake (time frame: 7.5 months). The study lists 2 primary outcomes in all. 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 5 Aug 2025.