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Text Message Nudges for COVID-19 Vaccination

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text message
Sponsored by
Ascension South East Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ascension Associate Employee

Exclusion Criteria:

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

Sites / Locations

  • Ascension

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Text message

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Percent receiving COVID-19 Vaccine
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
Time to COVID-19 vaccination in days within 4 weeks of the intervention.

Full Information

First Posted
September 7, 2021
Last Updated
July 18, 2022
Sponsor
Ascension South East Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05037201
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
November 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascension South East Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The control arm will receive usual health system messaging about the importance and deadlines for receiving COVID-19 vaccination.
Arm Title
Text message
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text message
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent receiving COVID-19 Vaccine
Description
The percent of participants that receive the COVID-19 vaccine within 2 weeks of the intervention.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Time to receive COVID-19 vaccine
Description
Time to COVID-19 vaccination in days within 4 weeks of the intervention.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ascension Associate Employee Exclusion Criteria: Prior vaccination for COVID-19 Exemption from COVID-19 vaccination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitesh Patel, MD, MBA
Organizational Affiliation
Ascension
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ascension
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63134
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual patient data will not be shared
Citations:
PubMed Identifier
35857327
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.
Results Reference
derived

Learn more about this trial

Text Message Nudges for COVID-19 Vaccination

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