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Evaluation of a Multilevel Intervention on Adult COVID-19 and Influenza Vaccination Rate

Evaluation of a Multilevel Intervention on Adult COVID-19 and Influenza Vaccination Rate

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06646406
Enrollment
114165
Registered
2024-10-17
Start date
2024-10-21
Completion date
2025-04-30
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Immunisation, Influenza Vaccine

Keywords

Adult, Vaccination, Influenza vaccines, COVID-19 Vaccines, Primary Health Care, Reminder Systems, Clinician communication, Patient communication

Brief 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. 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.

Interventions

BEHAVIORALPatient letter and 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

Sponsors

ModernaTX, Inc.
CollaboratorINDUSTRY
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients 19 years and older * Patients empaneled to 1 of 8 adult primary care practices as of September 2024

Exclusion criteria

* Patients 18 years or younger * Patients not empaneled to 1 of 8 adult primary care practices as of September 2024

Design outcomes

Primary

MeasureTime frameDescription
COVID-19 vaccine uptake7.5 monthsRates 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 uptake9 monthsRates of at least one dose of single licensed 2024-2025 trivalent influenza vaccine among adult patients at eight Mayo Clinic primary care practices

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026