Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05793788 |
| Other study ID # |
MAPinitial |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 9, 2023 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach
text messages 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.
Description:
Health maintenance measures have been shown to be critical in early detection, secondary
prevention, and early management of numerous medical conditions--from diabetes to various
cancers. The standardization of these health maintenance measures have resulted in major
improvements in population health. Despite the importance of these primary care tests and
screenings, many patients are overdue for these tests.
Given this healthcare gap, it is critical to investigate more effective strategies to
facilitate health maintenance measure completion. This study aims to evaluate the
effectiveness of a variety of behaviorally-informed outreach text messages. The investigators
intend to launch the study as a part of UCLA Health's My Action Plan initiative, a UCLA
Health primary care outreach quality improvement initiative aimed at encouraging patients to
complete their overdue health maintenance measures.
Specifically, the My Action Plan initiative is an outreach effort targeting 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). At the beginning
of each month, identified UCLA Health primary care patients will be randomized in a 1:1:1:1
ratio to receive one of four text messages informing them that they have an overdue health
maintenance measures and urging them to taking 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.
Within each text-message arm, patients will also be randomized to one of three time slots for
getting the message.
The My Action Plan quality improvement initiative is expected to start at the beginning of
the 2023 calendar year and continue for a span of at least 12 months. Each month, the
initiative targets patients whose birthday falls into that month. The investigators plan to
run this randomized clinical trial during four months of the larger QI initiative.
By studying how patients interact with these outreach messages and whether it then translates
to them completing their indicated health maintenance measures, the proposed study would
provide insightful information on how health systems could optimize electronic patient
outreach, narrow the gap in health maintenance measures in primary care, and ultimately
improve health on a population level.
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 Arm 1 with Arm 2 to test whether
more specific or general text message is more likely to improve the outcome measures
- Research question 2: The investigators will compare Arm 3, Arm 4, with Arm 2 to test
whether the general intention-oriented message and general action-oriented message can
outperform the general text message as well as which of these two messages is better.
- For research question 2, 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 Arm 2 as the ground truth.
Specifically, the investigators will take the aforementioned information about patients
in Arm 2 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 Arms 3 and 4 (vs. Arm 2).
- 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 messages varies across the
three times of the day when the reminders will be sent.
