Trusted Messengers: Intervention to Promote COVID-19 Vaccination

NCT04981392 | Completed Results

• 2 other identifiers: H000232541R01MD016883-01
• Study Type: interventional
• Target: 21,844
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Vaccination

Keywords

Covid-19; Vaccine Hesitancy; Vaccine Confidence

Outcome Measures

Primary Outcomes (1)

• COVID-19 Vaccination Within 3 Months

  The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 3 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).

  3 months

Secondary Outcomes (1)

• COVID-19 Vaccination Within 6 Months

  6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Primary care text message outreach to unvaccinated patients and resources to support PCPs

Behavioral: Primary care text message outreach to unvaccinated patients and resources to support PCPs

Control Arm

NO INTERVENTION

Patients will receive usual care

Interventions

Primary care text message outreach to unvaccinated patients and resources to support PCPs BEHAVIORAL

Patients: Eligible patients 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: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

COVID-19; Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Kimberly Fisher, MD
• Organization: UMass Chan Medical School

kimberly.fisher2@umassmed.edu

5088561975

Study Officials

• Kimberly A Fisher, M.D

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 29, 2021
• Study Start: June 2, 2022
• Primary Completion: October 25, 2023
• Study Completion: October 25, 2023
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)