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NCT07651761

Patient-Centered Practical Vaccine Talk For Busy Clinicians

Sponsor: University of Massachusetts, Worcester

View on ClinicalTrials.gov

Summary

The goal of this study is to assess the effect of an educational intervention for primary care providers (PCPs) on influenza and COVID-19 vaccine uptake among their adult patients through a pragmatic, cluster randomized trial in primary care clinics.

Official title: Patient-Centered Practical Vaccine Talk for Busy Clinicians (PCP-VAX): An Educational Intervention for Primary Care Providers on Influenza and COVID-19 Vaccine Uptake Among Adult Primary Care Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24500

Start Date

2026-07-15

Completion Date

2028-05-15

Last Updated

2026-06-16

Healthy Volunteers

Conditions

Influenza COVID-19

Interventions

OTHER

Provider communication training

Providers in participating intervention clinics will complete an educational program (PCP-VAX) on strategies for communicating with patients about the influenza and COVID-19 vaccines.

Inclusion criteria for primary care provider participants are as follows: * Practicing primary care provider at study clinic during the study period * Licensed independent practitioner (MD, DO, NP, PA), including residents Exclusion criteria for primary care provider participants are as follows: * PCPs at participating clinic sites who are members of the investigational team or part of the intervention * PCP participants who practice at more than one study clinic that are assigned to discordant study arms (e.g., control and intervention) will be excluded at the outset of the study. Inclusion criteria for patient participants are specified for each of the two co-primary outcomes as follows: Receipt of the 2026/2027 influenza vaccine, among eligible patients: * Have a qualifying clinic visit, defined as a clinic visit with a study PCP at one of the study clinics during the 2026/2027 influenza vaccine season\* * Have not received the 2026-2027 influenza vaccine prior to the qualifying clinic visit (patients who receive the influenza vaccine on the day of the qualifying study visit are eligible) * Adult (age \>= 18 years) Receipt of the 2026/2027 COVID-19 vaccine, among eligible patients: * Have a qualifying clinic visit, defined as a clinic visit with a study PCP at one of the study clinics during the 2026/2027 COVID-19 vaccine season\* * Have not received the 2026-2027 COVID-19 vaccine prior to the qualifying study visit (patients who receive the COVID-19 vaccine on the day of the qualifying study visit are eligible) * Have at least one risk factor for developing severe COVID-19 according to the CDC, including age \>= 65 years * Adult (age \>= 19 years) Exclusion criteria for patient participants for both co-primary outcomes are the following: * Resident of a state that does not share immunization data with the Massachusetts Immunization Information System (MIIS) For the purposes of this study, the 2026/2027 influenza and COVID-19 vaccine seasons are defined as September 1, 2026, or date the respective vaccine is available (whichever is later) through February 28, 2027. These dates were selected based on the timing of influenza and COVID-19 vaccine administration in prior years according to the Massachusetts immunization for respiratory disease data. This is referred to as the 'study period' elsewhere in the protocol.