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Covid19, VaccinesNCT04800965

Text-based Interventions to Promote COVID-19 Vaccinations

A study testing Patient MyChart Scheduling Link, Patient Educational Video and Enhanced Follow through Message in people with Covid19, Vaccines, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates whether and which type of text-based interventions affect the take-up of the COVID-19 vaccine. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19, Vaccines
What is being tested?
Patient MyChart Scheduling Link, Patient Educational Video and Enhanced Follow through Message
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200,000 participants
Where
1 siteUnited States
Study dates
31 Jan 2021to 1 Jan 2022
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

  • All patients who satisfy the following criteria will be eligible to be included in our study:
  • They have a mobile phone number or SMS capable phone number in UCLA Health's database
  • They are eligible for receiving the COVID-19 vaccine at UCLA Health
  • They have not already scheduled an appointment the day before the scheduled time of text message
  • They are at or above 18 years old

Who cannot join

  • Patients who already scheduled an appointment or obtained a COVID vaccine (at our collaborating health system or as documented in the California Immunization Registry (CAIR) https://cairweb.org/ ) by the time our text message is sent will be excluded from the analysis.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCLA Health Department of Medicine, Quality Office

    Westwood, Los Angeles, California, 90095

Other trials in United States

About this study

This study investigates whether and which type of text-based interventions affect the take-up of the COVID-19 vaccine.

Read the detailed description

This study investigates whether and which type of text-based interventions affect the take-up of the COVID-19 vaccine. The primary research question is whether vaccine takeup can be boosted by a text-message intervention encouraging eligible patients to schedule a vaccination appointment. Patients, when becoming eligible for receiving the COVID-19 vaccine at UCLA Health, will be first notified about their eligibility and encouraged to schedule a vaccination appointment via one of the channels (email, voice call, or snail mail) depending on the contact information available to UCLA Health. Then patients eligible for the study will be randomized at a 1:4 ratio into a holdout control arm that does not receive a text message vs. a text-message arm that receives a text message.

The secondary research question concerns which type of text message is more effective. To study this question, a nested 2x2 factorial design within the text-message arm will be used, where the two factors will be a) whether patients receive the link to an educational video specifically designed to shift patients' intentions to get the COVID-19 vaccine and b) whether the text message contains language aimed at encouraging patients to follow through on their intentions.

  • In the Holdout arm: patients will not receive text messages about COVID-vaccine.
  • In the text-message arm, all participants will receive a text message that invites them to schedule their vaccination appointment and includes a link to the appointment website
  • In the Simple Text sub-arm, participants will not receive any additional information.
  • In the Simple Text+Video sub-arm, together with the appointment link, participants will also receive a link to a 2-minute video in the text message. The video contains information about the prevalence of COVID-19 and the effectiveness and safety of the COVID-19 vaccine.
  • In the Enhanced Text sub-arm, in addition to the appointment link, the text message will use enhanced language aimed at reducing psychological barriers that prevent patients from scheduling their appointment.
  • In the Enhanced Text+Video sub-arm, in addition to the appointment link, the text message will encourage patients to watch a 2-minute video (the same as in the Simple Text+Video sub-arm) and use enhanced language aimed at reducing patients' psychological barriers of following through on scheduling an appointment.

Patients will enter our study on a rolling basis, as they become eligible to get the vaccine (and if they fit our inclusion criteria). For the first batch of patients, those in the text-message arm will receive the text message within 4 -10 days after the initial invitation is sent (because the infrastructure of running this study is not ready until then). For subsequent batches of patients, they will be randomized and receive the text message (if they are not in the holdout arm) the first weekday after the initial communication goes out. We will measure a) whether patients schedule a COVID-19 vaccination appointment for the first dose and b) whether and when patients get the first dose of COVID-19 vaccine.

Analysis:

For the main analysis, we will run ordinary least squares regressions (OLS) with robust standard errors to predict the aforementioned outcome variables, except that we will use a Cox proportional hazards model with administrative censoring to predict time of obtaining the first COVID-19 vaccine. The significance level will be 0.05. Our primary hypothesis is that the text-message arm is significantly better than the holdout arm, so our primary analysis will compare the four text-message sub-arms all together with the holdout group.

Our secondary analysis will investigate whether (1) the Simple Text sub-arm, (2) the two sub-arms containing a video, and (3) the two sub-arms containing enhanced language are better than the holdout arm.

Furthermore, we will test (1) the effect of adding a video (vs. no video) to the text, (2) the effect of adding enhanced language (vs not adding enhanced language), and (3) whether the combination of video and enhanced language will outperform video alone or enhanced language alone.

Our regressions will include the following control variables:

  • Participant age
  • Indicators for participant race/ethnicity (Black non-Hispanic, Hispanic, Asian non-Hispanic, white non-Hispanic, other/mixed, unknown; white non-Hispanic omitted)
  • Whether the patient's preferred language is Spanish (which affects the language of text)
  • Indicators for participant gender (male, female, other/unknown)
  • Social vulnerability index score
  • COVID19 Risk Factors Model
  • Indicators for the batches of patients (patients will become eligible and receive initial communications in batches)

As a robustness check, we will re-run the analysis as a logit regression (instead of an OLS regression) for binary outcome variables.

We will explore the following moderators:

  • Whether the patient is female or male
  • Whether the patient is Black, Caucasian, Hispanic, or other
  • Whether the patient's preferred language is Spanish
  • Whether the patient is 65+ (including 65) or below 65
  • Patient's Social vulnerability index score
  • Patient's COVID risk score
  • Patient's population risk score
  • Whether the patient is married (which is a proxy for whether they live together with family members)
  • Whether or not the patient received a flu shot in either the 2019-2020 season or the 2020-2021 flu season prior to receiving our text message according to the patient's medical record
  • The day of the week when the text message is sent to a patient. We will compare each day of the week.
  • How strongly the participant's neighborhood is in favor of the Republican (vs. Democratic) Party if UCLA Health eventually agrees to provide de-identified address (e.g., zipcode).

Plan for Early and Subsequent Analyses

To inform policy as soon as possible, we plan to first assess the effects of our interventions in the early phase of vaccination outreach at UCLA Health. For this purpose, we plan to first analyze the data from the start of this RCT to the end of February. Given that we are using a 6-day time window for our primary dependent variable, we will examine data from patients who are randomized to either the holdout or text-message arm in this RCT before or on Feb 23, 2021. For this population, we will test:

  1. whether the text-message arm is significantly better than the holdout arm;
  2. whether the Simple Text sub-arm, the two subarms containing a video, and the two sub-arms containing enhanced language are better than the holdout arm
  3. the effect of adding a video (vs. no video) to the text
  4. the effect of adding enhanced language (vs not adding enhanced language)
  5. whether (1), (2), (3), and (4) varies based on whether patients received the flu vaccination in either the 2019-2020 season or the 2020-2021 season
  6. we will report the raw data for each sub-arm without conducting hypothesis testing across conditions that are not pre-registered in (1)-(4).

In our early analysis, we will include controls that are available to us (it is possible that we do not have all of the controls described above at the time of early report).

After all UCLA patients have been invited (or if vaccine distribution plan changes and UCLA Health no longer sends out text messages to patients at some point), we will do the following additional analyses:

  • If the additional data collected afterwards exceeds 30K (which gives us 80% power to detect a 2pp difference between the holdout arm and the text message arm, assuming that holdout arm has a 50% baseline), then we will analyze the main effect of sending a text message (vs. holdout) and report the raw data for each sub-arm (to see if the patterns are qualitatively comparable with those in the early data).
  • We will use the full sample (including the early data and subsequent data) to analyze (1) whether the combination of video and enhanced language will outperform video alone or enhanced language alone and (2) the aforementioned heterogeneous treatment effect.
Being tested
Patient MyChart Scheduling Link, Patient Educational Video, Enhanced Follow through Message
Keywords
COVID19, Vaccines, Text-messages, Patient Outreach, Behavioral Science
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient MyChart Scheduling LinkBehavioural

    Text message includes a link for patients to sign on to their patient portal (Epic MyChart) and schedule their COVID-19 vaccine appointment.

  • Patient Educational VideoBehavioural

    Text message includes a link to a patient education video that aims to encourage patients to obtain the COVID-19 vaccine.

  • Enhanced Follow through MessageBehavioural

    Text message includes information that will use enhanced language aimed at reducing psychological barriers that prevent patients from scheduling their appointment.

Study groups in NCT04800965
Study groupRoleWhat they receive
Holdout ArmNo interventionIn the Holdout arm, patients will not receive text messages about COVID-vaccine.
Simple Text Sub-armExperimentalIn the Simple Text sub-arm, participants will not receive any additional information.
Receives: Behavioral: Patient MyChart Scheduling Link
Simple Text + Video Sub-armExperimentalIn the Simple Text+Video sub-arm, together with the appointment link, participants will also receive a link to a 2-minute video in the text message. The video contains information about the prevalence of COVID-19 and the effectiveness and safety of the COVID-19 vaccine.
Receives: Behavioral: Patient MyChart Scheduling Link; Behavioral: Patient Educational Video
Enhanced Text sub-ArmExperimentalIn the Enhanced Text sub-arm, in addition to the appointment link, the text message will use enhanced language aimed at reducing psychological barriers that prevent patients from scheduling their appointment.
Receives: Behavioral: Patient MyChart Scheduling Link; Behavioral: Enhanced Follow through Message
Enhanced Text + Video Sub-armExperimentalIn the Enhanced Text+Video sub-arm, in addition to the appointment link, the text message will encourage patients to watch a 2-minute video (the same as in the Simple Text+Video sub-arm) and use enhanced language aimed at reducing patients' psychological barriers of following through on scheduling an appointment.
Receives: Behavioral: Patient MyChart Scheduling Link; Behavioral: Patient Educational Video; Behavioral: Enhanced Follow through Message

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First COVID-19 Vaccine Appointment Scheduled at UCLA Health

    Whether patients schedule their vaccination appointment at UCLA Health within 6 days of receiving the text message (including the day of text message). Specifically, if t=the date of the text message (for the holdout arm, this refers to the date they would have received the text message had they not been assigned to the holdout arm), we will track vaccination appointments made by the end of t+5. While most people just make one appointment, a small percentage update their appointment time. We will have access to the latest few first-dose appointments people schedule by the time of data extraction.

    Measured: 6 days

Secondary outcomes (4)
  1. First COVID-19 Vaccine obtained at UCLA Health

    Whether patients get the first dose of COVID-19 vaccine at UCLA Health [time frame: 1 months from text message]

    Measured: 1 month from text message

  2. Time of obtaining the first COVID-19 vaccine at UCLA Health

    The date when patients obtain the first dose of COVID-19 vaccine at UCLA Health [time frame: 1 months from text message]

    Measured: 1 month from text message

  3. First COVID-19 Vaccine obtained at UCLA Health or any organization reporting to CAIR

    Whether patients obtain the first dose of COVID-19 vaccine at UCLA Health or another location reporting to the California Immunization Registry (CAIR). [time frame: 2 months from text message]

    Measured: 2 months from text message

  4. Time of obtaining the first COVID-19 at UCLA Health or another location reporting to CAIR

    The date when patients obtain the first dose of COVID-19 vaccine at UCLA Health or another location reporting to the California Immunization Registry (CAIR) [time frame: 2 months from text message]

    Measured: 2 months from text message

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start31 Jan 2021
  3. Primary completion31 Dec 2021
  4. Study completion1 Jan 2022

Resources

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
Participant, Care provider
Enrolment
200,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04800965
Sponsor's protocol ID
IRB#21-000268 (1)
Status last verified
Sep 2022
First submitted
6 Feb 2021
Last updated
13 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brewer NT, Chapman GB, Rothman AJ, Leask J, Kempe A. Increasing Vaccination: Putting Psychological Science Into Action. Psychol Sci Public Interest. 2017 Dec;18(3):149-207. doi: 10.1177/1529100618760521.

    PubMed 29611455
  • Haaland, I., Roth, C., & Wohlfart, J. (2020). Designing information provision experiments. CESifo Working Paper, No. 8406

  • Volpp KG, Loewenstein G, Buttenheim AM. Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program. JAMA. 2021 Jan 12;325(2):125-126. doi: 10.1001/jama.2020.24036. No abstract available.

    PubMed 33315079

Questions about this trial

What is this clinical trial studying?

A study testing Patient MyChart Scheduling Link, Patient Educational Video and Enhanced Follow through Message in people with Covid19, Vaccines, run by University of California, Los Angeles 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 5 inclusion and 1 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 13 Sep 2022. 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?

First COVID-19 Vaccine Appointment Scheduled at UCLA Health (time frame: 6 days). 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 NCT04800965, which also lists 3 linked publications.

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 13 Sep 2022.

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