Patient-Centered Practical Vaccine Talk For Busy Clinicians

NCT07651761 | Enrolling By Invitation

• 2 other identifiers: STUDY00001814R01MD018611
• Study Type: interventional
• Target: 24,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza; COVID-19

Keywords

prevention; provider training

Outcome Measures

Primary Outcomes (2)

• Receipt of 2026/2027 influenza vaccine

  Binary variable, yes/no

  Within one month of the end of the study period

• Receipt of 2026/2027 COVID-19 vaccine

  Binary variable, yes/no

  Within one month of the end of the study period

Secondary Outcomes (1)

• PCP self-efficacy in communicating with patients about vaccination, assessed via 4-questions developed for this study (4-point Likert scale)

  Up to 8-months after enrollment

Study Arms (2)

Intervention Arm

OTHER

Provider educational intervention.

Other: Provider communication training

Control Arm

NO INTERVENTION

Usual care

Interventions

Provider communication training OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Practicing primary care provider at study clinic during the study period
• Licensed independent practitioner (MD, DO, NP, PA), including residents

You may not qualify if:

• 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.
• 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)
• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01602, United States

Location

MeSH Terms

Conditions

Influenza, Human; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Study Officials

• Kimberly A Fisher, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data analysts and patient participants will be masked to the study arm allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 16, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 3 years after the end of the funding period.

Locations

US (1)