Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801524
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2021-03-15
Brief Title:
Text-based Reminders to Promote COVID-19 Vaccinations
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Text-based Reminders to Promote COVID-19 Vaccinations
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigates whether and which type of text-based reminders affect the take-up of the COVID-19 vaccine
Detailed Description:
Our primary research question is whether vaccine takeup can be boosted by a text-message reminder 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 Eligible patients will also receive a text-message reminder after the initial invitation Eight days after the first text reminder patients eligible for our study will be randomized at a 16 ratio into a holdout control arm that does not receive a second text message vs a text-message arm that receives a second text message
Our secondary research question concerns which type of text reminder is more effective To study this question we will nest a 2x3 factorial design within the text-message arm The first factor has two levels and is whether the text message focuses on patients personal benefits or prosocial benefits The second factor has three levels and is whether the text message highlights the early access patients have to the vaccine whether it highlights that the vaccine offers the promise of a fresh start or neither
In the Holdout arm patients will not receive a second text message 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 Self-benefit sub-arm participants will be reminded that the vaccine helps protect themselves from COVID
In the Prosocial-benefit sub-arm participants will be reminded that the vaccine helps protect their family friends and community from COVID
In the Early access self-benefit sub-arm participants will be reminded that they have early access to COVID-19 vaccine and should take the opportunity to protect themselves from COVID
In the Early access prosocial-benefit sub-arm participants will be reminded that they have early access to COVID-19 vaccine and should take the opportunity to protect their family friends community from COVID
In the Fresh start self-benefit sub-arm participants will be reminded that the vaccine offers the promise of a fresh start and they should take the opportunity to protect themselves from COVID and chart a new path forward
In the Early access prosocial-benefit sub-arm participants will be reminded that the vaccine offers the promise of a fresh start and they should take the opportunity to protect their family friends community from COVID and help our nation chart a new path forward
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 receiving the second text message Those in the text-message arm will receive the second text message on the workday on or closest to the 8th day following the first text message Specifically if t denotes the date of the first text message then t8 is the 8th day following the first text messageIf t8 is Saturday the second text message will be sent on Friday if t8 is Sunday the second text message will be sent on Monday 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
The study will stop assigning patients to the early access self-benefit sub-arm OR the early access prosocial-benefit sub-arm when UCLA health opens appointments to everyone regardless of priority status related to age health conditions or occupations This will be done because at this point the concept of early access is likely no longer credible At that point we will randomize future patients eligible for our study at a 14 ratio into the holdout control arm and a text-message arm that receives a second text message Within the text-message arm we will nest a 2x2 factorial design where the two factors will be a whether the text message will focus on patients personal benefits or prosocial benefits and b whether or not the text message highlights that the vaccine offers the promise of a fresh start
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 005 Our primary hypothesis is that the text-message arm is significantly better than the holdout arm so our primary analysis will compare the six text-message sub-arms altogether with the holdout group
Our secondary analysis will investigate whether 1 the three sub-arms highlighting self-benefits 2 the three sub-arms highlighting prosocial benefits 3 the two sub-arms highlighting early access and 4 the two sub-arms highlighting fresh start are better than the holdout arm
Furthermore we will test 1 the effect of highlighting prosocial benefits vs self-benefits 2 the effect of highlighting early access 3 the effect of highlighting the promise of a fresh start 4 whether the combination of early access and prosocial benefits will outperform early access alone or prosocial benefits alone and 5 whether the combination of fresh start and prosocial benefits will outperform fresh start alone or prosocial benefits alone
Our regressions will include the following control variables
Participant age
Indicators for participant raceethnicity Black non-Hispanic Hispanic Asian non-Hispanic white non-Hispanic othermixed unknown white non-Hispanic omitted
Whether the patients preferred language is Spanish which affects the language of text
Indicators for participant gender male female otherunknown
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 patients preferred language is Spanish
Whether the patient is 65 including 65 or below 65
Patients Social vulnerability index score
Patients COVID risk score
Patients 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 patients 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 participants neighborhood is in favor of the Republican vs Democratic Party if UCLA Health eventually agrees to provide de-identified address eg zipcode
The arm that patients were assigned to for the first text message see our pre-registration for the RCT related to the first text message at NCT04800965
Number of days between the date the first batch of patients received the initial invitation to get COVID vaccine at UCLA Health and the date a patient in question received the initial invitation
The number of patients who have received the initial invitation to get COVID vaccine at UCLA Health before a patient in question received the initial invitation
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 three sub-arms highlighting self-benefits the three sub-arms highlighting prosocial benefits the two sub-arms highlighting early access and the two sub-arms highlighting fresh start are better than the holdout arm
3 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
However if by Feb 23 we do not reach 40K 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 for this RCT we will only report estimated treatment effects and 95 confidence intervals but we will not perform any hypothesis testing
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 afterward exceeds 40K which gives us 80 power to detect a 2pp difference between the holdout arm and the text message arm 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
If we do not reach the sample size for the early analysis then we will use all the data including the early data and subsequent data to analyze the aforementioned questions for the early data
We will use the full sample including the early data and subsequent data to analyze 1 the effect of highlighting prosocial benefits vs self-benefits 2 the effect of highlighting early access 3 the effect of highlighting the promise of a fresh start 4 whether the combination of early access and prosocial benefits will outperform early access alone or prosocial benefits alone and 5 whether the combination of fresh start and prosocial benefits will outperform fresh start alone or prosocial benefits alone and 6 the aforementioned heterogeneous treatment effects
Our secondary research question concerns which type of text reminder is more effective To study this question we will nest a 2x3 factorial design within the text-message arm The first factor has two levels and is whether the text message focuses on patients personal benefits or prosocial benefits The second factor has three levels and is whether the text message highlights the early access patients have to the vaccine whether it highlights that the vaccine offers the promise of a fresh start or neither
In the Holdout arm patients will not receive a second text message 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 Self-benefit sub-arm participants will be reminded that the vaccine helps protect themselves from COVID
In the Prosocial-benefit sub-arm participants will be reminded that the vaccine helps protect their family friends and community from COVID
In the Early access self-benefit sub-arm participants will be reminded that they have early access to COVID-19 vaccine and should take the opportunity to protect themselves from COVID
In the Early access prosocial-benefit sub-arm participants will be reminded that they have early access to COVID-19 vaccine and should take the opportunity to protect their family friends community from COVID
In the Fresh start self-benefit sub-arm participants will be reminded that the vaccine offers the promise of a fresh start and they should take the opportunity to protect themselves from COVID and chart a new path forward
In the Early access prosocial-benefit sub-arm participants will be reminded that the vaccine offers the promise of a fresh start and they should take the opportunity to protect their family friends community from COVID and help our nation chart a new path forward
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 receiving the second text message Those in the text-message arm will receive the second text message on the workday on or closest to the 8th day following the first text message Specifically if t denotes the date of the first text message then t8 is the 8th day following the first text messageIf t8 is Saturday the second text message will be sent on Friday if t8 is Sunday the second text message will be sent on Monday 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
The study will stop assigning patients to the early access self-benefit sub-arm OR the early access prosocial-benefit sub-arm when UCLA health opens appointments to everyone regardless of priority status related to age health conditions or occupations This will be done because at this point the concept of early access is likely no longer credible At that point we will randomize future patients eligible for our study at a 14 ratio into the holdout control arm and a text-message arm that receives a second text message Within the text-message arm we will nest a 2x2 factorial design where the two factors will be a whether the text message will focus on patients personal benefits or prosocial benefits and b whether or not the text message highlights that the vaccine offers the promise of a fresh start
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 005 Our primary hypothesis is that the text-message arm is significantly better than the holdout arm so our primary analysis will compare the six text-message sub-arms altogether with the holdout group
Our secondary analysis will investigate whether 1 the three sub-arms highlighting self-benefits 2 the three sub-arms highlighting prosocial benefits 3 the two sub-arms highlighting early access and 4 the two sub-arms highlighting fresh start are better than the holdout arm
Furthermore we will test 1 the effect of highlighting prosocial benefits vs self-benefits 2 the effect of highlighting early access 3 the effect of highlighting the promise of a fresh start 4 whether the combination of early access and prosocial benefits will outperform early access alone or prosocial benefits alone and 5 whether the combination of fresh start and prosocial benefits will outperform fresh start alone or prosocial benefits alone
Our regressions will include the following control variables
Participant age
Indicators for participant raceethnicity Black non-Hispanic Hispanic Asian non-Hispanic white non-Hispanic othermixed unknown white non-Hispanic omitted
Whether the patients preferred language is Spanish which affects the language of text
Indicators for participant gender male female otherunknown
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 patients preferred language is Spanish
Whether the patient is 65 including 65 or below 65
Patients Social vulnerability index score
Patients COVID risk score
Patients 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 patients 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 participants neighborhood is in favor of the Republican vs Democratic Party if UCLA Health eventually agrees to provide de-identified address eg zipcode
The arm that patients were assigned to for the first text message see our pre-registration for the RCT related to the first text message at NCT04800965
Number of days between the date the first batch of patients received the initial invitation to get COVID vaccine at UCLA Health and the date a patient in question received the initial invitation
The number of patients who have received the initial invitation to get COVID vaccine at UCLA Health before a patient in question received the initial invitation
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 three sub-arms highlighting self-benefits the three sub-arms highlighting prosocial benefits the two sub-arms highlighting early access and the two sub-arms highlighting fresh start are better than the holdout arm
3 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
However if by Feb 23 we do not reach 40K 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 for this RCT we will only report estimated treatment effects and 95 confidence intervals but we will not perform any hypothesis testing
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 afterward exceeds 40K which gives us 80 power to detect a 2pp difference between the holdout arm and the text message arm 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
If we do not reach the sample size for the early analysis then we will use all the data including the early data and subsequent data to analyze the aforementioned questions for the early data
We will use the full sample including the early data and subsequent data to analyze 1 the effect of highlighting prosocial benefits vs self-benefits 2 the effect of highlighting early access 3 the effect of highlighting the promise of a fresh start 4 whether the combination of early access and prosocial benefits will outperform early access alone or prosocial benefits alone and 5 whether the combination of fresh start and prosocial benefits will outperform fresh start alone or prosocial benefits alone and 6 the aforementioned heterogeneous treatment effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None