NCT05037201

Brief Summary

The COVID-19 pandemic has caused significant morbidity and mortality across the world. Effective vaccines are now available but underutilized. In July 2021, Ascension Health implemented a mandate requiring all employees to obtain the COVID-19 vaccine by November 12th. In August 2021, the number of COVID-19 cases in the US increased rapidly, specifically in states with lower vaccination rates, many of which are served by Ascension Health facilities. In this study, we will evaluate a rapidly deployed health system initiative to use text messaging to nudge Ascension employees who have not yet been vaccinated to commit to a date and receive vaccination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

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

September 7, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2021

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

14 days

First QC Date

September 7, 2021

Last Update Submit

April 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent receiving COVID-19 Vaccine

    The percent of participants that receive the COVID-19 vaccine within 2 weeks of the intervention.

    2 weeks

Secondary Outcomes (1)

  • Time to receive COVID-19 vaccine

    4 weeks

Study Arms (2)

Usual care

NO INTERVENTION

The control arm will receive usual health system messaging about the importance and deadlines for receiving COVID-19 vaccination.

Text message

EXPERIMENTAL

The intervention arm will receive a text message stating that the vaccine is reserved for them on a specific date. They will have the ability to reschedule to a different day, opt-out of this text messaging intervention, or if previously vaccinated they can upload documentation to the Ascension website.

Behavioral: Text message

Interventions

Text messageBEHAVIORAL

The intervention arm will receive a text message stating that the vaccine is reserved for them on a specific date. They will have the ability to reschedule to a different day, opt-out of this text messaging intervention, or if previously vaccinated they can upload documentation to the Ascension website.

Text message

Eligibility Criteria

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

You may qualify if:

  • Ascension Associate Employee

You may not qualify if:

  • Prior vaccination for COVID-19
  • Exemption from COVID-19 vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ascension

St Louis, Missouri, 63134, United States

Location

Related Publications (1)

  • Patel MS, Fogel R, Winegar AL, Horseman C, Ottenbacher A, Habash S, Dukes JL, Brinson TC, Price SC, Masoudi FA, Cacchione J, Yehia BR. Effect of Text Message Reminders and Vaccine Reservations on Adherence to a Health System COVID-19 Vaccination Policy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2222116. doi: 10.1001/jamanetworkopen.2022.22116.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mitesh Patel, MD, MBA

    Ascension

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
VP, Ascension

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 8, 2021

Study Start

October 11, 2021

Primary Completion

October 25, 2021

Study Completion

November 8, 2021

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Individual patient data will not be shared

Locations