Text Message Nudges for COVID-19 Vaccination

Sponsor

Ascension South East Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT05037201

Collaborator

(none)

2,000

Enrollment

Location

Arms

Actual Duration (Days)

2174.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

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

Study Type:

Interventional

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 :

Oct 11, 2021

Actual Primary Completion Date :

Oct 25, 2021

Actual Study Completion Date :

Nov 8, 2021

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Percent receiving COVID-19 Vaccine [2 weeks]
The percent of participants that receive the COVID-19 vaccine within 2 weeks of the intervention.

Secondary Outcome Measures

Time to receive COVID-19 vaccine [4 weeks]
Time to COVID-19 vaccination in days within 4 weeks of the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Ascension Associate Employee

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ascension	Saint Louis	Missouri	United States	63134

Sponsors and Collaborators

Ascension South East Michigan

Investigators

Principal Investigator: Mitesh Patel, MD, MBA, Ascension

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ascension South East Michigan

ClinicalTrials.gov Identifier:

NCT05037201

Other Study ID Numbers:

RAS20210002

First Posted:

Sep 8, 2021

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 20, 2022