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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 24,500
- 试验地点
- 1
- 主要终点
- Receipt of 2026/2027 influenza vaccine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Data analysts and patient participants will be masked to the study arm allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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,
- •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.
研究组 & 干预措施
Control Arm
Usual care
Intervention Arm
Provider educational intervention.
干预措施: Provider communication training (Other)
结局指标
主要结局
Receipt of 2026/2027 influenza vaccine
时间窗: Within one month of the end of the study period
Binary variable, yes/no
Receipt of 2026/2027 COVID-19 vaccine
时间窗: Within one month of the end of the study period
Binary variable, yes/no
次要结局
- 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)
研究者
Kimberly Fisher
Associate Professor
University of Massachusetts, Worcester