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COVID-19NCT05586178

Information Provision and Consistency Framing to Increase COVID-19 Booster Uptake

A study testing Reminder that facilitates action, Consistency framing and Information provision about the uniqueness of the bivalent booster in people with COVID-19 and 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 different ways to elevate intentions to get the COVID-19 booster via text-based reminders, including providing information about the booster and leveraging the consistency principle. The proposed randomized controlled trial will examine the impact of these reminders on booster uptake. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, Vaccines
What is being tested?
Reminder that facilitates action, Consistency framing and Information provision about the uniqueness of the bivalent booster
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177,720 participants
Where
1 siteUnited States
Study dates
18 Oct 2022to 31 Dec 2023
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

  • Patients aged 18 or above
  • Have a mobile phone number or SMS-capable phone number in UCLA Health's database
  • Having completed a COVID-19 vaccine primary series based on CAIR data
  • Last COVID-19 vaccine shot (including booster shot) occurred at least two months before the date when patient list are pulled in preparation for the trial, based on CAIR data. The last two criteria meant to identify patients who are eligible for the updated booster.

Who cannot join

  • Patients who have received the bivalent booster anywhere (based on CAIR data) before the day they receive the text message
  • Patients who have already scheduled appointments at UCLA Health for getting the bivalent booster before the day they receive the text message

Trial locations and contacts

1 site in 1 country.

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

    Los Angeles, California, 90095

Other trials in United States

About this study

This study investigates different ways to elevate intentions to get the COVID-19 booster via text-based reminders, including providing information about the booster and leveraging the consistency principle. The proposed randomized controlled trial will examine the impact of these reminders on booster uptake.

Read the detailed description

The proposed randomized controlled trial will take place a few weeks after UCLA Health notified its patients about bivalent COVID-19 boosters. The trial will test whether text-based reminders can increase uptake of bivalent COVID-19 boosters and examine different ways to elevate intentions to get the booster. This trial will include a randomly selected ~40% of patients from all UCLA Health patients eligible to receive the COVID-19 bivalent booster at the time of the study, with 35% of the remaining eligible patients randomly allocated to another trial (Pre-registration title: "Boost intentions and Facilitate Action to Promote Covid-19 Booster Take-up") and 25% randomly allocated to a third trial (Pre-registration title: "Effects of Prompt to Bundle Covid-19 Booster and Flu Shot"). The three trials will be run simultaneously.

Patients randomly selected for this trial will be randomized at an equal share to 7 conditions: an Holdout condition that does not receive a text reminder and 6 additional conditions that receive a text message (simple reminder, uniqueness information reminder, eligibility information reminder, severity information reminder, consistency reminder, and consistency and uniqueness information reminder; see description in the Arm/Interventions section). Within each arm, patients are further randomized into one of the 33 time slots for when they will receive the text message (i.e., 3 time points per day including 9am, 12pm, 4pm for 11 days). Days 1-4 and 8-11 have slightly fewer patients than Days 5-7.

First, to test whether the text reminders increase vaccine uptake, the investigators will compare the holdout condition to the combination of the 6 reminder arms.

The investigators will also investigate additional questions:

  1. The investigators will investigate how the information provision strategies affect vaccine uptake. For this purpose, the investigators will compare vaccine uptake and link click rates between (1) the uniqueness information reminder, (2) the eligibility information reminder, and (3) the severity information reminder. If there are significant differences across three information provision reminders in a given outcome, the investigators will separately compare these three reminders with the simple reminder and the holdout arm. If there are not significant differences across the three information provision reminders in a given outcome, the investigators will compare the average of these three reminders with the simple reminder and holdout. The investigators will also compare the simple reminder with the holdout arm. For the severity information reminder, the investigators have competing predictions. On one hand, highlighting underestimated severity may increase the perceived importance of the vaccine; on the other hand, the negative valence of this message may create reactance, leading people to avoid thinking about COVID-19 and vaccination.
  2. The investigators will investigate how the consistency framing affects vaccine uptake and whether the combination of consistency and uniqueness information has a positive effect. On one hand, the psychological literature about the consistency principle suggests that people strive to behave consistently with their past actions and positions; thus, reminding people that they have completed the primary series and have done a good job at protecting their health may motivate them to consistently take care of themselves by getting the bivalent booster. On the other hand, patients may get complacent after being reminded that they have already finished the primary series, thinking that they have already completed the necessary steps to protect themselves. Hence, the investigators have competing predictions about whether the consistency framing can effectively increase vaccine uptake. The combination of consistency and uniqueness information about how the bivalent booster differs from the previous doses may be most powerful. To understand the role of consistency framing, the investigators will compare the consistency reminder with the simple reminder (in both vaccine uptake and link click rates) and the holdout condition (in vaccine uptake only). To test the effect of consistency framing and uniqueness information, the investigators will compare the consistency and uniqueness information reminder with the consistency reminder, the uniqueness information reminder, simple reminder, and holdout, respectively.
  3. The investigators will explore the role of the time when a text message is sent. The investigators will examine how the effect of text reminders (i.e., the combination of the 6 reminder arms vs. holdout) varies across days and times. As additional specifications, the investigators will control for the time trend and analyze all patients who have not gotten the bivalent booster in California or scheduled a booster appointment at UCLA Health the day before the trial starts.

Analysis:

The investigators will run ordinary least squares regressions (OLS) with robust standard errors to predict the aforementioned outcome variables, except that the investigators will use a Cox proportional hazards model with administrative censoring to predict time of obtaining the booster. The significance level will be 0.05. The regressions will include the following control variables:

  • Indicators for one of the 33 time slots
  • Participant age (If there will be a missing value, the investigators will replace with the mean and add a dummy variable to indicate patients with missing age)
  • Indicators for participant race/ethnicity (Black non-Hispanic, Hispanic, Asian non-Hispanic, white non-Hispanic, other/mixed, unknown)
  • Indicators for participant gender (male, female, other/unknown)

The investigators will test whether the main effect of sending text reminders (i.e., the combination of the 6 reminder arms vs. holdout) is robust regardless of:

  • Whether the patient is female or male
  • Whether the patient is white non-hispanic or racial/ethnical minority
  • Whether the patient is 65+ (including 65) or below 65

The investigators will investigate the following moderators for (1) the effect of sending a text reminder to facilitate action and (2) the effect of boosting intentions via information provision; since the investigators have competing predictions about the effectiveness of consistency framing, the investigators will exclude the arms containing consistency framing from this analysis:

  • Timing of the first dose of the COVID-19 vaccine primary series
  • Whether patients got at least one original booster before the trial starts
  • Whether or not the patient received a flu shot in either the 2020-2021 season or the 2021-2022 flu season according to the patient's medical record
  • How strongly the patient's neighborhood is in favor of the Republican (vs. Democratic) Party if UCLA Health eventually agrees to provide de-identified addresses (e.g., zip code) and if the sample includes patients living in Republican-leaning counties.

Additional information: Three days into this trial, the investigators learned that the supply of boosters at UCLA Health is very limited and patients could not find appointments at UCLA Health. The investigators verified that local pharmacies continue to have appointments available. Thus, the investigators updated all text messages to (1) explain that UCLA Health has limited booster appointments available, (2) no longer provide a direct link to schedule appointments at UCLA Health, and (3) instead encourage patients to make an appointment at local pharmacies.

Conditions
COVID-19, Vaccines
Being tested
Reminder that facilitates action, Consistency framing, Information provision about the uniqueness of the bivalent booster, Information provision about bivalent booster eligibility, Information provision about the severity of COVID-19 symptoms
Keywords
COVID19, Vaccines, Text-messages, Patient Outreach, Behavioral Science, Information provision
Medical subject headings
COVID-19

What participants receive

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

  • Reminder that facilitates actionBehavioural

    Patients will receive a text message reminding them that they can now get the bivalent COVID-19 booster and facilitating action. The message will contain a link to schedule a booster appointment at UCLA Health and a link to vaccine.gov (where people can find local pharmacies that carry the bivalent booster).

  • Consistency framingBehavioural

    The message will leverage the psychological principle of consistency. It will highlight to patients that based on medical records, they have completed a COVID-19 vaccine primary series, have done a great job protecting their health, and can now get the bivalent booster.

  • Information provision about the uniqueness of the bivalent boosterBehavioural

    The message will contain information about how the bivalent booster differs from previous doses patients have received and why it is valuable.

  • Information provision about bivalent booster eligibilityBehavioural

    The message will clarify to patients that regardless of whether they are at high risk, received the original boosters, or previously got COVID-19, they are eligible for the bivalent booster based on their medical records, and the updated booster will be valuable for them.

  • Information provision about the severity of COVID-19 symptomsBehavioural

    The message will contain information about the often underestimated chances of people developing severe or long-lasting COVID-19 symptoms. The message will also mention that the bivalent booster can reduce such chances.

Study groups in NCT05586178
Study groupRoleWhat they receive
HoldoutNo interventionNot described
Simple reminderExperimentalNot described
Receives: Behavioral: Reminder that facilitates action
Consistency reminderExperimentalNot described
Receives: Behavioral: Reminder that facilitates action; Behavioral: Consistency framing
Uniqueness information reminderExperimentalNot described
Receives: Behavioral: Reminder that facilitates action; Behavioral: Information provision about the uniqueness of the bivalent booster
Eligibility information reminderExperimentalNot described
Receives: Behavioral: Reminder that facilitates action; Behavioral: Information provision about bivalent booster eligibility
Severity information reminderExperimentalNot described
Receives: Behavioral: Reminder that facilitates action; Behavioral: Information provision about the severity of COVID-19 symptoms
Consistency and uniqueness information reminderExperimentalNot described
Receives: Behavioral: Reminder that facilitates action; Behavioral: Consistency framing; Behavioral: Information provision about the uniqueness of the bivalent booster

What is being measured

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

  1. booster take-up in 2 weeks

    Whether people receive the bivalent booster at any location reporting to the California Immunization Registry (CAIR)

    Measured: 2 weeks after getting the text message

  2. booster take-up in 4 weeks

    Whether people receive the bivalent booster at any location reporting to the California Immunization Registry (CAIR)

    Measured: 4 weeks after getting the text message

Secondary outcomes (1)
  1. Link click rate in 1 week

    Whether people click on at least one link provided in the text message

    Measured: 1 week after getting the 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 posted19 Oct 2022
  2. Study start18 Oct 2022
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2023

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
177,720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586178
Sponsor's protocol ID
covidbooster2
Status last verified
Dec 2024
First submitted
17 Oct 2022
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Reminder that facilitates action, Consistency framing and Information provision about the uniqueness of the bivalent booster in people with COVID-19 and 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 4 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 5 Dec 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?

booster take-up in 2 weeks (time frame: 2 weeks after getting the text message). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Dec 2024.

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