Clinical trial NCT05037201: Text Message Nudges for COVID-19 Vaccination
Official title: A Randomized Trial of Text Message-Based Nudges to Increase COVID-19 Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Eligibility criteria: Inclusion Criteria:

* Ascension Associate Employee

Exclusion Criteria:

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

Primary outcomes:
measure: Percent receiving COVID-19 Vaccine
timeFrame: 2 weeks
Secondary outcomes:
measure: Time to receive COVID-19 vaccine
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Ascension
state: Missouri
Study officials:
affiliation: Ascension
name: Mitesh Patel, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.