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Text Message Nudges for COVID-19 Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05037201
Recruitment Status : Completed
First Posted : September 8, 2021
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Ascension South East Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Behavioral: Text message Not Applicable

Detailed Description:

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.

Nudges are subtle changes to the way information is framed or choices are offered that can have a significant impact on behavior. Status quo bias is a preference for the current state which is often used as a reference point when making decisions. Changes from the reference point are often faced with high inertia and this prevents changes in behavior. Default options are the setting of the baseline reference point and are often taken as an implicit recommendation. In prior work, changing default options has led to significant changes in health-related behaviors. For example, changing prescription default settings in the EHR from opt-in to opt-out for generic prescriptions increased the rate of generic prescriptions from 75% to 98% across Penn Medicine (Patel et al. Annals of IM. 2014; Patel et al. JGIM 2018). Framing program participation as opt-out has led to a 22% increase in enrollment in a COVID-19 surveillance testing program (Oakes et al. NEJM Catalyst 2021) and triple enrollment in remote monitoring programs for medication adherence (Mehta et al. JAMA Cardiology. 2018) and diabetes management (Aysola et al. AJHP 2016)

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized Trial of Text Message-Based Nudges to Increase COVID-19 Vaccination
Actual Study Start Date : October 11, 2021
Actual Primary Completion Date : October 25, 2021
Actual Study Completion Date : November 8, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Usual care
The control arm will receive usual health system messaging about the importance and deadlines for receiving COVID-19 vaccination.
Experimental: Text message
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percent receiving COVID-19 Vaccine [ Time Frame: 2 weeks ]
    The percent of participants that receive the COVID-19 vaccine within 2 weeks of the intervention.


Secondary Outcome Measures :
  1. Time to receive COVID-19 vaccine [ Time Frame: 4 weeks ]
    Time to COVID-19 vaccination in days within 4 weeks of the intervention.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ascension Associate Employee

Exclusion Criteria:

  • Prior vaccination for COVID-19
  • Exemption from COVID-19 vaccination
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037201


Locations
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United States, Missouri
Ascension
Saint Louis, Missouri, United States, 63134
Sponsors and Collaborators
Ascension South East Michigan
Investigators
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Principal Investigator: Mitesh Patel, MD, MBA Ascension
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ascension South East Michigan
ClinicalTrials.gov Identifier: NCT05037201    
Other Study ID Numbers: RAS20210002
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases