Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06131723 |
Other study ID # |
AWVinitial |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 8, 2023 |
Est. completion date |
April 30, 2025 |
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 clinical trial evaluating how a behaviorally-informed outreach email
notification impacts patient engagement with primary care. This 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.
The main question it aims to answer is if sending an enhanced email notification (i.e.,
enhanced tickler email) to identified UCLA Health primary care patients increases their
engagement with primary care.
Participants will be assigned to either a control (standard tickler email) or treatment
(enhanced tickler email) condition, based on whether their birth date ends in an odd or even
number. Researchers will compare control and treatment groups to see if and how they differ
in pre-defined outcome measures.
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 has 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
communicate to patients about health maintenance measures they need to complete. This study
aims to evaluate the effectiveness of a behaviorally-informed outreach email message. 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 (MAP) initiative is an outreach effort targeting primary
care patients at UCLA Health who have outstanding, clinically indicated primary care
preventative care gaps (e.g., overdue colorectal cancer screening, outstanding diabetes
tests). At the beginning of the month following their birth month, patients with at least one
of these open care gaps receive a MAP Letter in the form of a patient portal message. The MAP
Letter contains a personalized list of outstanding preventive care items and actionable steps
to complete the items. When the MAP Letter is received in the patient portal, it triggers an
email "tickler" that is sent to patients' personal email address to notify them of the
patient portal message.
At the beginning of each month, patients who are due to receive a MAP Letter will be assigned
to receive either the current standard email tickler used by UCLA Health (control tickler) or
a behaviorally-informed email tickler (enhanced tickler), based on whether their birth date
ends in an odd or even number. The control email will notify them that they have a new
message posted in their MyChart patient portal account, and prompt them to sign in to read
it. The behaviorally-informed email will directly notify them that they are due for an
important medical exam and prompt them to sign in to their MyChart patient portal account to
schedule their recommended appointment; this message will be signed by their primary care
doctor's office. In each month, emails will go out to all eligible patients in both
conditions at the same time.
Both email notifications will contain links to the patient's MyChart portal account. The
control tickler will link patients to their MyChart patient portal home page (standard
procedure for email ticklers), whereas the enhanced tickler will link patients directly to
the MAP Letter.
The investigators plan to run this clinical trial for 12 months.
By studying whether patients review the MAP letter and whether or not the engagement
translates into completing health maintenance measures, the proposed study will provide
insightful information on how health systems could optimize electronic patient outreach.
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 an indicator variable for arm assignment.
- The analysis will control for sex, age, race/ethnicity, indicators for screenings/tests
that patients are due for (which are marked on their MAP letter), and whether patients
have upcoming primary care appointments at the time of MAP outreach. Missing covariate
values will be handled by including 'unknown' indicators, along with mean imputation for
quantitative covariates.
- Exploratory analyses will investigate heterogeneous treatment effects by patients'
baseline motivation (i.e., the extent to which patients seem to have an intention to get
the screenings/tests), which will be proxied by each patient's history of
screenings/tests. Specifically, the investigators 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 prior to the MAP outreach (the investigators aim for
10 years, but the exact time window is 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 complete the screenings/tests patients are due
for.
- The investigators will explore whether the difference between conditions is moderated by
how frequently patients have seen their PCP in the past few years prior to the MAP
outreach (the investigators target 3 years, but the exact time window is based on data
availability).
- Additionally, the investigators will investigate whether the translation of engagement
with the MAP Letter to actual appointment scheduling and screening/test completion
(defined later in the secondary outcome section) depends on whether patients face
structural barriers to get screenings/tests. The investigators will explore proxies
including socioeconomic factors at the zipcode level (social vulnerability, income),
insurance type, and distance from UCLA Health clinics (as a proxy for accessibility to
healthcare).