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Patient-Centered Practical Vaccine Talk For Busy Clinicians (PCP-VAX)

10. juni 2026 opdateret af: Kimberly Fisher, University of Massachusetts, Worcester

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrolarm
Sædvanlig pleje
Andet: Intervention Arm
Provider educational intervention.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Receipt of 2026/2027 influenza vaccine
Tidsramme: Within one month of the end of the study period
Binary variable, yes/no
Within one month of the end of the study period
Receipt of 2026/2027 COVID-19 vaccine
Tidsramme: Within one month of the end of the study period
Binary variable, yes/no
Within one month of the end of the study period

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Kimberly A Fisher, MD, University of Massachusetts, Worcester

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juli 2026

Primær færdiggørelse (Anslået)

15. maj 2028

Studieafslutning (Anslået)

15. maj 2028

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified data, data dictionaries, and statistical code will be made available in the eScholarship@UMassChan repository at the time of publication.

IPD-delingstidsramme

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med COVID-19

Kliniske forsøg med Provider communication training

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