NCT04805931

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:

  1. 1.Control arm - receives a text message with standard messaging
  2. 2.Arm 2 - receives a text message with a message framed for scarcity
  3. 3.Arm 3 - receives a text message with a message framed for improving the social good

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,311

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

March 11, 2021

Last Update Submit

June 25, 2021

Conditions

Covid19Vaccine Refusal

Outcome Measures

Primary Outcomes (1)

  • Vaccine appointments scheduled/completed

    % of first-dose vaccine appointments scheduled/vaccines completed

    7 days post randomization

Study Arms (3)

Control

NO INTERVENTION

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.

Scarcity

EXPERIMENTAL

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.

Behavioral: Behavioral economics

Social good

EXPERIMENTAL

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.

Behavioral: Behavioral economics

Interventions

Behavioral economicsBEHAVIORAL

Tailored behavioral economic text messaging vs. standard text messaging

ScarcitySocial good

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

MeSH Terms

Conditions

COVID-19Vaccination Refusal

Interventions

Economics, Behavioral

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychologyBehavioral SciencesBehavioral Disciplines and ActivitiesEconomicsHealth Care Economics and Organizations

Study Officials

  • Ashok Reddy, MD, MS

    VA Puget Sound

    PRINCIPAL INVESTIGATOR

  • Karin Nelson, MD, MSHS

    VA Puget Sound

    STUDY DIRECTOR

  • Linnaea Schuttner, MD, MD

    VA Puget Sound

    PRINCIPAL INVESTIGATOR

  • Stefanie Deeds, MD

    VA Puget Sound

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaina Mori, BA

CONTACT

(206) 247-6782alaina.mori@va.gov

Stefanie Deeds, MD

CONTACT

206-314-0757Stefanie.Deeds@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Prospective, randomized controlled, parallel groups trial
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 18, 2021

Study Start

March 15, 2021

Primary Completion

May 1, 2021

Study Completion

November 1, 2021

Last Updated

June 28, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)