UCLA Health Department of Medicine, Quality Office
Westwood, Los Angeles, California, 90095, United States
NCT Number: NCT04800965
This study investigates whether and which type of text-based interventions affect the take-up of the COVID-19 vaccine.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Westwood, Los Angeles, California, 90095, United States
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.
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:
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:
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:
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All patients who satisfy the following criteria will be eligible to be included in our study:
Exclusion criteria
Text message includes a link for patients to sign on to their patient portal (Epic MyChart) and schedule their COVID-19 vaccine appointment.
Text message includes a link to a patient education video that aims to encourage patients to obtain the COVID-19 vaccine.
Text message includes information that will use enhanced language aimed at reducing psychological barriers that prevent patients from scheduling their appointment.
Time frame: 6 days
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.
Time frame: 1 month from text message
Whether patients get the first dose of COVID-19 vaccine at UCLA Health [time frame: 1 months from text message]
Time frame: 1 month from text message
The date when patients obtain the first dose of COVID-19 vaccine at UCLA Health [time frame: 1 months from text message]
Time frame: 2 months from text message
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]
Time frame: 2 months from text message
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]
University of California, Los Angeles
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04801524
COVID-19, Coronaviridae Infections
Westwood, Los Angeles, California, United States
View Trial DetailsNCT04763681
COVID-19, Coronaviridae Infections
Toronto, Ontario, Canada
View Trial DetailsNCT04747249
COVID-19, Coronaviridae Infections
Caen, France
View Trial DetailsNCT06305793
COVID-19, Chronic Disease
Durham, North Carolina, United States
View Trial Details