Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05791955
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2023-03-17
Brief Title:
UCLA Health Patient Health Maintenance With Interactive Text Reminder
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
UCLA Health Patient Health Maintenance With Interactive Text Reminder
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text message reminders impact patient engagement with primary care This prospective randomized control trial is being implemented in conjunction with UCLA Healths larger quality improvement initiative the My Action Plan Quality Improvement Initiative in order to improve primary care preventive measure completion rates
Detailed Description:
UCLA Health will launch an initiative called My Action Plan which is an outreach effort targeting the primary care patients at UCLA who have an outstanding clinically indicated primary care preventative care gap eg overdue colorectal cancer screening outstanding diabetes tests and aims at encouraging patients to complete their overdue health maintenance measures
At the beginning of each month identified UCLA Health primary care patients will be enrolled in a trial the investigators have pre-registered under the title UCLA Health Patient Health Maintenance Outreach Text Message and randomized to receive one of four text messages informing them that they have overdue health maintenance measures and urging them to take action to complete these measures These text messages will contain a link to their MyChart patient portal account specifically linking them to a My Action Plan electronic letter that will contain a personalized list of outstanding preventive care items and actionable steps to complete the items
In May and June 2023 if patients do not open their My Action Plan electronic letter within 7 days of initial outreach they will be enrolled in the trial described in the current pre-registration This trial will evaluate the effect of sending a text reminder about health gaps as well as compare the effectiveness of different outreach text reminders Patients will be randomly assigned at the 1111 ratio to either the holdout control condition without a reminder or one of the three reminder arms receiving one of three text reminders 2 weeks after the initial outreach message Of these three reminder arms one will serve as a control reminder message and the other two will be interactive experimental reminder messages that ask participants for a text response Additionally within each text-reminder arm patients will be randomized to one of three time slots for getting the reminder The investigators will examine patients interaction with these reminders and how that ultimately translates to them completing their indicated health maintenance measures
The UCLA Department of Medicine DOM intends to roll out this QI initiative at the beginning of the 2023 calendar year and continue it for a span of at least 12 months Each month the initiative targets patients whose birthday falls into that month This proposed trial will run for two months May and June 2023
Analysis Plan
The investigators will utilize patient-level ordinary least squares OLS estimation with statistical inferences based on model-robust standard errors The primary model term will be indicator variables for arm assignment
The analysis will adjust for sex age raceethnicity indicators for screeningstests that patients are due for and whether patients have upcoming primary care appointments Missing covariate values will be handled by including unknown indicators along with mean imputation for quantitative covariates
The investigators will use this dataset to address two separate research questions
Research question 1 The investigators will compare the average of Arms 2-4 with Arm 1 to test the average effect of sending a text reminder If the average effect is significant the investigators will explore if Arms 2 3 and 4 separately differ from Arm 1
Research question 2 The investigators will compare Arm 3 Arm 4 with Arm 2 to test the effectiveness of adding an interactive component to enhance intentions to close the health gap Arm 3 or to prompt action Arm 4
Exploratory analyses will investigate heterogeneous treatment effects by patients baseline motivation ie the extent to which patients seem to have some intentions to get the screeningstests in two ways First the investigators will use each patients history of screeningstests to construct a proxy for their baseline motivation to obtain the due screeningstests Specifically the investigator will calculate among all the screeningstests that are included in the My Action Plan Initiative and that a patient was due for in the past few years exact time window TBD based on data availability what percentage was completed by the patient as far as UCLA Health could tell A higher percentage indicates a higher baseline motivation to get the screeningstests patients are due for during the study period Second the investigators will obtain demographics and medical information that UCLA Health is willing to provide eg gender age raceethnicity history of cancer and other pre-existing conditions family cancer history past adherence to screeningstests that are included in the My Action Plan Initiative past receipt of influenza vaccination frequency of doctor visits time window of these variables is TBD depending on data availability With such information the investigators will train an algorithm to predict patients baseline motivation level using patients in the holdout condition Arm 1 as the ground truth Specifically the investigators will take the aforementioned information about patients in Arm 1 as input and use whether they complete any of the screeningsvisits recommended in the My Action Plan letter within 6 months as the outcome measure Then the investigators will apply the algorithm to all patients to predict their baseline motivation level For both approaches the proxy for baseline motivation Approach 1 and the predicted baseline motivation level Approach 2 will be used to analyze the heterogeneous treatment effects of 1 Arms 3 and 4 vs Arm 2 and 2 the combination of Arms 2 and 4 vs Arm 1
Additionally the investigators will investigate proxies for whether patients face structural barriers to get screeningstests as moderators including socioeconomic factors at the zipcode level insurance type proxies for accessibility to healthcare resources such as distance from UCLA Health clinics
The investigators will also explore how the effect of text reminders varies across the three times of the day when the reminders will be sent
At the beginning of each month identified UCLA Health primary care patients will be enrolled in a trial the investigators have pre-registered under the title UCLA Health Patient Health Maintenance Outreach Text Message and randomized to receive one of four text messages informing them that they have overdue health maintenance measures and urging them to take action to complete these measures These text messages will contain a link to their MyChart patient portal account specifically linking them to a My Action Plan electronic letter that will contain a personalized list of outstanding preventive care items and actionable steps to complete the items
In May and June 2023 if patients do not open their My Action Plan electronic letter within 7 days of initial outreach they will be enrolled in the trial described in the current pre-registration This trial will evaluate the effect of sending a text reminder about health gaps as well as compare the effectiveness of different outreach text reminders Patients will be randomly assigned at the 1111 ratio to either the holdout control condition without a reminder or one of the three reminder arms receiving one of three text reminders 2 weeks after the initial outreach message Of these three reminder arms one will serve as a control reminder message and the other two will be interactive experimental reminder messages that ask participants for a text response Additionally within each text-reminder arm patients will be randomized to one of three time slots for getting the reminder The investigators will examine patients interaction with these reminders and how that ultimately translates to them completing their indicated health maintenance measures
The UCLA Department of Medicine DOM intends to roll out this QI initiative at the beginning of the 2023 calendar year and continue it for a span of at least 12 months Each month the initiative targets patients whose birthday falls into that month This proposed trial will run for two months May and June 2023
Analysis Plan
The investigators will utilize patient-level ordinary least squares OLS estimation with statistical inferences based on model-robust standard errors The primary model term will be indicator variables for arm assignment
The analysis will adjust for sex age raceethnicity indicators for screeningstests that patients are due for and whether patients have upcoming primary care appointments Missing covariate values will be handled by including unknown indicators along with mean imputation for quantitative covariates
The investigators will use this dataset to address two separate research questions
Research question 1 The investigators will compare the average of Arms 2-4 with Arm 1 to test the average effect of sending a text reminder If the average effect is significant the investigators will explore if Arms 2 3 and 4 separately differ from Arm 1
Research question 2 The investigators will compare Arm 3 Arm 4 with Arm 2 to test the effectiveness of adding an interactive component to enhance intentions to close the health gap Arm 3 or to prompt action Arm 4
Exploratory analyses will investigate heterogeneous treatment effects by patients baseline motivation ie the extent to which patients seem to have some intentions to get the screeningstests in two ways First the investigators will use each patients history of screeningstests to construct a proxy for their baseline motivation to obtain the due screeningstests Specifically the investigator will calculate among all the screeningstests that are included in the My Action Plan Initiative and that a patient was due for in the past few years exact time window TBD based on data availability what percentage was completed by the patient as far as UCLA Health could tell A higher percentage indicates a higher baseline motivation to get the screeningstests patients are due for during the study period Second the investigators will obtain demographics and medical information that UCLA Health is willing to provide eg gender age raceethnicity history of cancer and other pre-existing conditions family cancer history past adherence to screeningstests that are included in the My Action Plan Initiative past receipt of influenza vaccination frequency of doctor visits time window of these variables is TBD depending on data availability With such information the investigators will train an algorithm to predict patients baseline motivation level using patients in the holdout condition Arm 1 as the ground truth Specifically the investigators will take the aforementioned information about patients in Arm 1 as input and use whether they complete any of the screeningsvisits recommended in the My Action Plan letter within 6 months as the outcome measure Then the investigators will apply the algorithm to all patients to predict their baseline motivation level For both approaches the proxy for baseline motivation Approach 1 and the predicted baseline motivation level Approach 2 will be used to analyze the heterogeneous treatment effects of 1 Arms 3 and 4 vs Arm 2 and 2 the combination of Arms 2 and 4 vs Arm 1
Additionally the investigators will investigate proxies for whether patients face structural barriers to get screeningstests as moderators including socioeconomic factors at the zipcode level insurance type proxies for accessibility to healthcare resources such as distance from UCLA Health clinics
The investigators will also explore how the effect of text reminders varies across the three times of the day when the reminders will be sent
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