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

NCT06646406 | Completed

• 1 other identifier: 24-007738
• Study Type: interventional
• Target: 114,165
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19 Immunisation; Influenza Vaccine

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  9 months

Study Arms (2)

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

Behavioral: Patient letter and clinician communication

No intervention

NO INTERVENTION

No intervention

Interventions

Patient letter and clinician communication BEHAVIORAL

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

Also known as: Reminder systems, Clinician communication

Patient letter and clinician communication

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• ModernaTX, Inc.: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Lila J. Rutten, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Services Research; Chair, Division of Epidemiology, Department of Quantitative Health Sciences

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 17, 2024
• Study Start: October 21, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

US (2)