COVID-19, Influenza
Conditions
Keywords
prevention, provider training
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.
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
OTHERProvider 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.
Sponsors
University of Massachusetts, Worcester
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Data analysts and patient participants will be masked to the study arm allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of 2026/2027 influenza vaccine | Within one month of the end of the study period | Binary variable, yes/no |
| Receipt of 2026/2027 COVID-19 vaccine | Within one month of the end of the study period | Binary variable, yes/no |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKimberly A Fisher, MD
University of Massachusetts, Worcester
Outcome results
None listed