Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800965
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2021-02-06
Brief Title:
Text-based Interventions to Promote COVID-19 Vaccinations
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Text-based Interventions 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 interventions affect the take-up of the COVID-19 vaccine
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 14 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 TextVideo 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 TextVideo 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 TextVideo 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 005 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 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
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
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 TextVideo 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 TextVideo 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 TextVideo 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 005 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 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
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
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