- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05793788
UCLA Health Patient Health Maintenance Outreach Text Message
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA Health Department of Medicine, Quality Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Empaneled to UCLA Health DOM Primary Care
- Has at least one overdue health maintenance measure that the My Action Plan initiative focuses on
- Has an active MyChart status
- Can accept SMS messages from UCLA Health
- Has a March, April, May or June Birthday
Exclusion Criteria:
- Under the age of 18
- Deceased patients
- Hospice patients
- Has opted out electronic communication (bulk messages, email, and/or text)
- For the final analysis, we will further exclude patients who have scheduled appointments for all screening/tests or completed all screenings/tests prior to the date when they are supposed to receive the text message
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: Specific
Eligible, randomized participant will receive a brief, specific SMS message informing patients that they should obtain screenings and tests they are due for.
|
The investigators will send randomized participants an SMS message encouraging them to click 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. Message content will vary based on randomization arm as noted below.
The message will inform patients that the care team has identified tests/screenings that they are due for.
|
|
Experimental: Arm 2: General
Eligible, randomized participant will receive a brief, generic SMS message informing patients that they have a health gap to be closed.
|
The investigators will send randomized participants an SMS message encouraging them to click 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. Message content will vary based on randomization arm as noted below.
The message will inform patients that the care team has identified a care gap in their record.
|
|
Experimental: Arm 3: Intention-oriented; General
Eligible, randomized participant will receive an intention-oriented, generic SMS message informing patients that they have a health gap to be closed and highlighting the importance of doing so.
|
The investigators will send randomized participants an SMS message encouraging them to click 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. Message content will vary based on randomization arm as noted below.
The message will inform patients that the care team has identified a care gap in their record.
The message will point out that even if patients feel healthy, their doctor recommends them to take care of their health gaps.
|
|
Experimental: Arm 4: Action-oriented; General
Eligible, randomized participant will receive an action-oriented, generic SMS-message informing patients that they have a health gap to be closed and prompting them to act soon before they forget.
|
The investigators will send randomized participants an SMS message encouraging them to click 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. Message content will vary based on randomization arm as noted below.
The message will inform patients that the care team has identified a care gap in their record.
The message will prompt patients to take care of their health gaps right away before they forget.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opening link within SMS Text message
Time Frame: 1 week after getting the outreach text message
|
Percentage of participants across the different arms who click on the link from the outreach message
|
1 week after getting the outreach text message
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opening My Action Plan Letter
Time Frame: 1 week after getting the outreach text message
|
Percentage of participants across the different arms who open their personalized My Action Plan letter
|
1 week after getting the outreach text message
|
|
Direct scheduling appointment rate
Time Frame: 2 weeks after getting the outreach text message
|
Rate of which eligible participants directly schedule an appointment for diabetic retinal exams, diabetes education, or breast cancer screening in order to complete these overdue screening/test(s).
These screenings/tests have dedicated appointment resources that people can directly schedule for.
|
2 weeks after getting the outreach text message
|
|
Rate of taking action for one overdue screening/test
Time Frame: 2 weeks after getting the outreach text message
|
Rate of which participants schedule an appointment to complete their overdue screening/test or start the online tool for colorectal screening
|
2 weeks after getting the outreach text message
|
|
Completion rate of one screening/test
Time Frame: 6 months after getting the outreach text message
|
Rate of completion of at least one screening/test within the observation window
|
6 months after getting the outreach text message
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MAPinitial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of Colorado, DenverMassachusetts General Hospital; Ann & Robert H Lurie Children's Hospital of... and other collaboratorsRecruitingDiabetes Mellitus | Diabetes | Type 2 Diabetes | Diabetes Mellitus Type 2 | Diabetes Mellitus, Type I | Diabetes Mellitus Type II | Diabetes Mellitus, Insulin-Dependent | Diabetes, Autoimmune | Type 1 Diabetes (T1D) | Diabetes Type 2 on Insulin | Diabetes, Type IIUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of North Carolina, Chapel HillAmerican Diabetes AssociationNot yet recruitingType 2 Diabetes Mellitus (T2DM) | Diabetes (DM) | Insulin Dependent Diabetes | Type 1 Diabetes (T1D) | Diabetes Education | Diabetes Care | Diabetes (Insulin-requiring, Type 1 or Type 2)United States
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
University of North Carolina, Chapel HillAmerican Heart AssociationRecruitingType 2 Diabetes | Nutrition | Diabetes Type 2 | T2DM (Type 2 Diabetes Mellitus) | Diabetes Mellitis | T2DM | Diabetes EducationUnited States
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
COUR Pharmaceutical Development Company, Inc.RecruitingType 1 Diabetes | Type 1 Diabetes Mellitus | T1DM | T1D | Type 1 Diabetes in Adolescence | Type 1 Diabetes in Children | Type 1 Diabetes Patients | Type 1 Diabetes Mellitis | T1DM - Type 1 Diabetes Mellitus | Type 1 Diabetes (Juvenile Onset)United States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceCompletedType 2 Diabetes Mellitus | Pre DiabetesAustralia
Clinical Trials on Outreach Text Messages
-
Friedrich-Alexander-Universität Erlangen-NürnbergPhilipps University Marburg Medical CenterCompleted
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
Children's Hospitals and Clinics of MinnesotaHealthPartners InstituteUnknownAsthmaUnited States
-
Duke UniversityNational Cancer Institute (NCI)CompletedSmoking | PregnancyUnited States
-
Medical University of South CarolinaRoswell Park Cancer InstituteCompleted
-
Auburn UniversityCompleted
-
Centre for Addiction and Mental HealthHealth CanadaCompleted
-
Vanderbilt University Medical CenterCompleted
-
Imperial College LondonBarts & The London NHS Trust; Mid and South Essex NHS Foundation Trust; Royal... and other collaboratorsCompleted
-
University of ManchesterNorthern Care Alliance NHS Foundation Trust; University of Oxford; Manchester...Completed