Clinical trial NCT04981392: Trusted Messengers: Intervention to Promote COVID-19 Vaccination
Official title: Trusted Messengers: Supporting Physicians in Promoting COVID-19 Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Vaccination
Keywords: Covid-19
Vaccine Hesitancy
Vaccine Confidence
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-07-29
Enrollment: 21844
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will be tested using a pragmatic, cluster randomized clinical trial. Randomization will occur at the clinic level. Clinics will be matched by practice setting (Academic, Community, Federally Qualified Health Center) and other characteristics as possible. Within each pair, clinics will be randomly allocated to either the intervention or usual care Arm.
Primary purpose: PREVENTION

Brief summary: The study aims to assess the impact of a multicomponent intervention to support Primary Care Provider (PCP) outreach to promote COVID-19 vaccination among vulnerable patients in and near Worcester, MA via a pragmatic, cluster randomized trial.

Detailed description: The goal of this study is to increase uptake of the COVID-19 vaccine among vulnerable populations through systematic primary care (PCP or clinic) text message outreach to unvaccinated patients, information provision via a study website, and resources to support PCPs.

The clinical trial will randomize 14 primary care clinics from three health systems in the Worcester, Massachusetts area to intervention or control. Eligible patients seen at a study clinic randomized to the intervention will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.

Providers at a study clinic randomized to the intervention will be provided resources to support their conversations with unvaccinated patients during the intervention. Resources will include access to the study website, factsheets to share with vaccine hesitant patients, prescription pads to be used to "prescribe' the website, and an electronic "smartphrase" that can automatically add information about the study website and how to schedule a COVID-19 vaccination to patients' After Visit Summary and/or clinic note.

Eligibility criteria: Inclusion Criteria:

* Patients seen by a PCP at a participating clinic site within 3-years prior to study start
* Age \> / = 18 years

Exclusion Criteria:

* Patients who have received at least one dose of a COVID-19 vaccine series prior to the start of the intervention
* Non-Massachusetts residents

Primary outcomes:
measure: COVID-19 Vaccination Within 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: COVID-19 Vaccination Within 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Kimberly A Fisher, M.D
role: PRINCIPAL_INVESTIGATOR
References: