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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05037201
Other study ID # RAS20210002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 11, 2021
Est. completion date November 8, 2021

Study information

Verified date July 2022
Source Ascension South East Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date November 8, 2021
Est. primary completion date October 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ascension Associate Employee Exclusion Criteria: - Prior vaccination for COVID-19 - Exemption from COVID-19 vaccination

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Ascension Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Ascension South East Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent receiving COVID-19 Vaccine The percent of participants that receive the COVID-19 vaccine within 2 weeks of the intervention. 2 weeks
Secondary Time to receive COVID-19 vaccine Time to COVID-19 vaccination in days within 4 weeks of the intervention. 4 weeks
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