Covid19NCT05037201
Text Message Nudges for COVID-19 Vaccination
A study testing Text message in people with Covid19, run by Mitesh Patel at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Text message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 8 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ascension Associate Employee
Who cannot join
- Prior vaccination for COVID-19
- Exemption from COVID-19 vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Text Message-Based Nudges to Increase COVID-19 Vaccination
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.
Read the 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)
- Conditions
- Covid19
- Being tested
- Text message
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | The control arm will receive usual health system messaging about the importance and deadlines for receiving COVID-19 vaccination. |
| Text message | Experimental | 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. Receives: Behavioral: Text message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent receiving COVID-19 Vaccine
The percent of participants that receive the COVID-19 vaccine within 2 weeks of the intervention.
Measured: 2 weeks
Secondary outcomes (1)
Time to receive COVID-19 vaccine
Time to COVID-19 vaccination in days within 4 weeks of the intervention.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start11 Oct 2021
- Primary completion25 Oct 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitesh Patel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Mitesh Patel, Ascension Health
- Investigators
- Mitesh Patel, MD, MBA, Principal investigator, Ascension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037201
- Sponsor's protocol ID
- RAS20210002
- Status last verified
- Apr 2024
- First submitted
- 7 Sep 2021
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared
Publications
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.
PubMed 35857327
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Text Message-Based Nudges to Increase COVID-19 Vaccination
- ClinicalTrials.gov ID
- NCT05037201
- Acronym / sponsor ID
- RAS20210002
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Mitesh PatelIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –The control arm will receive usual health system messaging about the importance and deadlines for receiving COVID-19 vaccination. |
| Text message | Experimental | Behavioral: Text messageThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ascension Associate Employee
Key exclusion criteria (2 listed)
- Prior vaccination for COVID-19
- Exemption from COVID-19 vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text messageThe 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. | Behavioural | Text message |
Primary outcome
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.
1 secondary outcome
Time to receive COVID-19 vaccine
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Derived from this study: PubMed 35857327Patel 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.
- Individual participant dataSharing planned: No. Individual patient data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitesh Patel, MD, MBA principal investigator
Ascension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message in people with Covid19, run by Mitesh Patel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent receiving COVID-19 Vaccine (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05037201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.