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Trial Title:
UCLA Health Patient Health Maintenance With Interactive Text Reminder
NCT ID:
NCT05791955
Condition:
Health Maintenance
Diabetes
Cancer
Conditions: Keywords:
primary care
digital outreach
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel-arm randomized control trial
Primary purpose:
Health Services Research
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Behavioral
Intervention name:
Reminder of preventive care measures
Description:
The investigators will send randomized participants an SMS reminder encouraging them to
click the provided link and close their outstanding, overdue preventive care measures.
The provided link will take them to their MyChart login page; after logging in, they
would see their personalized My Action Plan Letter detailing their personalized, overdue
preventive care measures.
Arm group label:
Control Reminder
Arm group label:
Personal Responsibility Reminder
Arm group label:
Planning prompt reminder
Intervention type:
Behavioral
Intervention name:
Acknowledgement of personal responsibility
Description:
The message will contain a request for the participant to take personal responsibility
for their health by either clicking on the link to make an appointment or replying
"noted" to the text message.
Arm group label:
Personal Responsibility Reminder
Intervention type:
Behavioral
Intervention name:
Planning prompt
Description:
The message will prompt people to either click on the link to make an appointment now or
text back when they plan to close their health gap
Arm group label:
Planning prompt reminder
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
Health's 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 (e.g., 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 1:1:1:1 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, race/ethnicity, indicators for screenings/tests
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 (i.e., the extent to which patients seem to have some intentions to
get the screenings/tests) in two ways. First, the investigators will use each patient's
history of screenings/tests to construct a proxy for their baseline motivation to obtain
the due screenings/tests. Specifically, the investigator will calculate, among all the
screenings/tests 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 screenings/tests patients
are due for during the study period. Second, the investigators will obtain demographics
and medical information that UCLA Health is willing to provide (e.g., gender, age,
race/ethnicity, history of cancer and other pre-existing conditions, family cancer
history, past adherence to screenings/tests 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 screenings/visits 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 screenings/tests 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Empaneled to UCLA Health DOM Primary Care
2. Has at least one overdue health maintenance measure that the My Action Plan
initiative focuses on
3. Has an active MyChart status
4. Can accept SMS messages from UCLA Health
5. Has not opened the My Action Plan electronic letter within 7 days of initial
outreach
6. Has a May or June Birthday
Exclusion Criteria:
1. Under the age of 18
2. Deceased patients
3. Hospice patients
4. Has opted out electronic communication (bulk messages, email, and/or text)
5. For the final analysis, the investigators will further exclude patients who have
scheduled appointments for all screenings/tests or completed all screenings/tests
prior to the date when they are supposed to receive the reminder from this trial
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA Health Department of Medicine, Quality Office
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Start date:
May 23, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
University of California, Los Angeles
Agency class:
Other
Collaborator:
Agency:
UCLA Health Department of Medicine
Agency class:
Other
Source:
University of California, Los Angeles
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05791955