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

26 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

24500

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Worcester, Massachusetts, Verenigde Staten, 01602
        • UMass Chan Medical School

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Bedieningsarm
Gebruikelijke zorg
Ander: Intervention Arm
Provider educational intervention.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Receipt of 2026/2027 influenza vaccine
Tijdsspanne: 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
Tijdsspanne: Within one month of the end of the study period
Binary variable, yes/no
Within one month of the end of the study period

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Massachusetts, Worcester

Medewerkers

National Institute on Minority Health and Health Disparities (NIMHD)

Onderzoekers

  • Hoofdonderzoeker: Kimberly A Fisher, MD, University of Massachusetts, Worcester

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 juni 2026

Primaire voltooiing (Geschat)

15 mei 2028

Studie voltooiing (Geschat)

15 mei 2028

Studieregistratiedata

Eerst ingediend

4 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2026

Eerst geplaatst (Werkelijk)

16 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

26 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00001814
  • R01MD018611 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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