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VEText Message Framing and Covid-19 Vaccine Uptake Among at Risk Veterans (VEText)

Primary Purpose

Covid19, Vaccine Refusal

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral economics
Sponsored by
VA Puget Sound Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.

Inclusion Criteria:

  • Veterans must be enrolled into VHA care
  • Veterans must meet age or illness institutional priority guidelines for eligibility for COVID-19 vaccine receipt

Exclusion Criteria:

  • None

Sites / Locations

  • VA Puget Sound Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Scarcity

Social good

Arm Description

Will receive a text message with standard messaging used to alert veterans that they are eligible for COVID-19 vaccine and offer scheduling embedded within the text message.

Will receive a text message with a behavioral scarcity message used to alert veterans that they are eligible for COVID-19 vaccine and offer scheduling embedded within the text message.

Will receive a text message with a behavioral social good message used to alert veterans that they are eligible for COVID-19 vaccine and offer scheduling embedded within the text message.

Outcomes

Primary Outcome Measures

Vaccine appointments scheduled/completed
% of first-dose vaccine appointments scheduled/vaccines completed

Secondary Outcome Measures

Full Information

First Posted
March 11, 2021
Last Updated
June 25, 2021
Sponsor
VA Puget Sound Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT04805931
Brief Title
VEText Message Framing and Covid-19 Vaccine Uptake Among at Risk Veterans
Acronym
VEText
Official Title
COVID-19 Vaccine Rollout: VEText Message Framing and Covid-19 Vaccine Uptake Among at Risk Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Puget Sound Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different targeted outreach interventions aimed at increasing Covid-19 vaccine uptake. Veterans who are eligible for COVID-19 vaccine receipt by priority status (based on institutional guidelines) will be identified. Veterans must be enrolled into Veterans Health Administration (VHA) care and meet age or illness institutional priority guidelines to be eligible. Veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation at an individual level, using permuted block randomization (with random block sizes of 3 and 6) to the following interventions: Control arm - receives a text message with standard messaging Arm 2 - receives a text message with a message framed for scarcity Arm 3 - receives a text message with a message framed for improving the social good
Detailed Description
OBJECTIVE: To compare the effectiveness of different text message reminders sent through an interactive mobile system (VEText) at increasing Covid-19 vaccine uptake among at risk Veterans. OVERVIEW: This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different targeted outreach interventions at increasing Covid-19 vaccine uptake. Veterans who are eligible for Covid-19 vaccine receipt by priority status (based on institutional guidelines) will be identified. Veterans must be enrolled into VHA care and meet age or illness institutional priority guidelines to be eligible. Veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation at an individual level, using permuted block randomization (with random block sizes of 3 and 6) to the following interventions: Control arm - receives a text message with standard messaging Arm 2 - receives a text message with a behavioral scarcity message Arm 3 - receives a text message with a behavioral social good message Randomization will be stratified by VA center (VA Puget Sound or American Lake). Due to operational constraints, only one type of text message can be sent per day/batch. In order to account for any potential differences with the day of the week the text message is received, the three arm messages will be randomized by day of the week each week. For example, week 1 will have the control group message sent on Monday, the arm 2 message sent on Tuesday, and the arm 3 message sent on Wednesday. Week 2 will have the arm 2 message sent on Monday, the control group message sent on Tuesday, and the arm 3 message sent on Wednesday. Text messages will be sent based on the randomized order generated and will continue on those days of the week that the center has vaccine available. Our primary outcome of interest is the vaccine scheduling and/or completion rate within 7 days of receipt of the text message. Enrollment in the trial will occur between March 15, 2021 and May 1, 2021. Primary aims: Aim 1a: Investigate differences in vaccine scheduling/completion rates among different outreach strategies. Will test the hypothesis (HA1) that the proportion of Veterans either scheduling a vaccine appointment for a first dose or receiving a first vaccine dose varies between targeted behavioral messaging and standard messaging (arms 2 + 3 vs. control) at 7 days post randomization. Aim 1b: Investigate differences in vaccine scheduling/completion rates among different outreach strategies. Will test the hypothesis (HA1) that the proportion of Veterans either scheduling a vaccine appointment for a first dose or receiving a first vaccine dose varies between different types of behavioral messaging (arm 2 vs. arm 3) at 7 days post randomization. Secondary aims: None Sub-analyses: None STUDY POPULATION: All Veterans who are eligible for a first dose of Covid-19 vaccine by priority status (based on institutional guidelines). STUDY TIME PERIOD The enrollment period for the study is March 15, 2021 and May 1, 2021. Data collection and analysis will continue through at least 6 months post enrollment for the last Veteran evaluated. DATA SOURCES: Table: CDWWork.SVeteran.SMVIPerson Time period: Screening/enrollment Description: Contact information for kit/letter mailing and subsequent reminder calls Variable of interest: Name, address, zip code, phone number, SSN. Table: CDWWork.SVeteran.SMVIPerson Time period: Screening/enrollment Description: Demographics Analytic variable(s) of interest: DOB, age, gender, marital status, DOD (if applicable), service connectedness, copay. Table: Communicator report (not CDW table) Time period: Post randomization Description: Provides automated call information Analytic variable(s) of interest: Call date/time, Patient response, Result from non-response. Table: CDWWork.Appt.Appointment, CDWWork.Dim.Location Time period: Post randomization Description: Scheduled vaccination appointments Analytic variable(s) of interest: Appointment date/time, location. Table: CDWWork.Immun.Immunization, CDWWork.Dim.ImmunizationName Time period: Post randomization Description: Detailed vaccination receipt records Analytic variable(s) of interest: Vaccine receipt date/time, location. STATISTICAL ANALYSES AND DESCRIPTION OF MAIN TABLES Sample size analysis assuming a baseline vaccination proportion of approximately 33% among Veterans aged 65 and older (estimates based on vaccination data pulled 03/10/21) the estimated total sample size required to provide at least 80% power to detect a 5% difference between Arms 2 + 3 and the control arm is 4311 total (1437 per group). Descriptive patient-level statistics will be presented using the Pearson chi-square test for dichotomous variables and the Student's t test for continuous variables. The primary intention-to-treat analysis will use logistic regression to test the association between randomization group and vaccine scheduling/completion 7 days post randomization, adjusting for VHA center as a stratification variable. Odds ratios and predicted probabilities from this model will be reported. All descriptive and main analyses will be performed using R version 3.6.1. P-values < 0.05 will be considered statistically significant. Aim 1a Statistical Analyses Will test the hypothesis (HA1) that the proportion of Veterans scheduling an appointment for the first vaccine dose or receiving a first vaccine dose varies between targeted behavioral messaging and standard messaging (arms 2 + 3 vs. control) at 7 days post randomization. Aim 1b Statistical Analyses Will test the hypothesis (HA1) that different types of behavioral messaging will have differing effects on vaccine scheduling/vaccine completion at 7 days post randomization (arm 2 vs. arm 3) STUDY OUTCOMES Primary analyses: % of first-dose vaccine appointments scheduled/vaccines completed at 7 days post randomization STUDY COVARIATES Primary analyses: Covariate of interest: intervention group indicator

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Vaccine Refusal

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized controlled, parallel groups trial
Masking
Participant
Allocation
Randomized
Enrollment
4311 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Will receive a text message with standard messaging used to alert veterans that they are eligible for COVID-19 vaccine and offer scheduling embedded within the text message.
Arm Title
Scarcity
Arm Type
Experimental
Arm Description
Will receive a text message with a behavioral scarcity message used to alert veterans that they are eligible for COVID-19 vaccine and offer scheduling embedded within the text message.
Arm Title
Social good
Arm Type
Experimental
Arm Description
Will receive a text message with a behavioral social good message used to alert veterans that they are eligible for COVID-19 vaccine and offer scheduling embedded within the text message.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral economics
Intervention Description
Tailored behavioral economic text messaging vs. standard text messaging
Primary Outcome Measure Information:
Title
Vaccine appointments scheduled/completed
Description
% of first-dose vaccine appointments scheduled/vaccines completed
Time Frame
7 days post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request. Inclusion Criteria: Veterans must be enrolled into VHA care Veterans must meet age or illness institutional priority guidelines for eligibility for COVID-19 vaccine receipt Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaina Mori, BA
Phone
(206) 247-6782
Email
alaina.mori@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Stefanie Deeds, MD
Phone
206-314-0757
Email
Stefanie.Deeds@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Reddy, MD, MS
Organizational Affiliation
VA Puget Sound
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karin Nelson, MD, MSHS
Organizational Affiliation
VA Puget Sound
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Linnaea Schuttner, MD, MD
Organizational Affiliation
VA Puget Sound
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefanie Deeds, MD
Organizational Affiliation
VA Puget Sound
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linnaea Schuttner, MD
Phone
206-277-6126
Email
linnaea.schuttner@va.gov
First Name & Middle Initial & Last Name & Degree
Alaina Mori, BA
Phone
206-247-6782
Email
alaina.mori@va.gov
First Name & Middle Initial & Last Name & Degree
Ashok Reddy, MD
First Name & Middle Initial & Last Name & Degree
John Geyer, MD
First Name & Middle Initial & Last Name & Degree
Stefanie Deeds, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

VEText Message Framing and Covid-19 Vaccine Uptake Among at Risk Veterans

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