Patient-Centered Practical Vaccine Talk For Busy Clinicians

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

Overview

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.

Detailed description

Low uptake of the COVID-19 and influenza vaccines is a major public health threat. An estimated 234,000 deaths due to COVID-19 could have been prevented between June 2021 and March 2022 through vaccination. Yet, only 20% of US adults are up to date on COVID-19 vaccination, despite widespread vaccine availability, and evidence of vaccine effectiveness at preventing hospitalization or death. Similarly, flu shots prevented an estimated 105,000 hospitalizations and 6,300 deaths during the 2019-2020 season alone, but only 50% of adults received a flu shot in the 2020-2021 influenza season, and these rates have been declining in the years since.

Healthcare provider (HCP) recommendations increase uptake of COVID-19 and influenza vaccines. Interventions that leverage the central role of HCPs in recommending vaccination are a promising means of increasing vaccination coverage. Yet many PCPs are unsure how to communicate effectively with patients who decline vaccination, indicating a need for strategies and training in how to effectively communicate with patients about the COVID-19 and influenza vaccines.

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. Our hypothesis is that training PCPs in evidence-based communication strategies (e.g., making a presumptive recommendation, responding with elements of MI) via the PCP-VAX intervention will be superior to usual care with regards to influenza and COVID-19 vaccine uptake. The trial will be conducted among primary care clinics from 3 health systems in central Massachusetts, including community primary care practices, academic primary care practices, and Federally Qualified Health Centers.

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.

Primary outcome measures

• Receipt of 2026/2027 influenza vaccine [Time frame: Within one month of the end of the study period]
• Receipt of 2026/2027 COVID-19 vaccine [Time frame: Within one month of the end of the study period]

Secondary outcome measures (1)

• PCP self-efficacy in communicating with patients about vaccination, assessed via 4-questions developed for this study (4-point Likert scale) [Time frame: Up to 8-months after enrollment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

United States · 1 center

• UMass Chan Medical School — Worcester

Identifiers

NCT: NCT07651761 · STUDY00001814 · R01MD018611

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗