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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05979987
Other study ID # MAPreminder3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 27, 2023
Est. completion date July 31, 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 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.


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 July 2023, if participants do not open their My Action Plan electronic letter within 7 days after the initial outreach, they will be enrolled in the trial described in the current pre-registration. Patients will be randomly assigned in a 1:1:1:1 ratio to receive one of four text reminders 2 weeks after the initial outreach message. 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 one month (July 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 first compare Arm 2 with Arm 1 to test the effect of encouraging patients to read the story about a patient whose life was saved by preventive screening.. If the difference is significant in an outcome measure, the investigators will then compare Arms 3 and 4 with Arms 1 and 2 to shed light on why Arm 2 differs from Arm 1. Exploratory analyses will investigate heterogeneous treatment effects of Arm 2 (vs. Arm 1) by patients' 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10000
Est. completion date July 31, 2024
Est. primary completion date April 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 July 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Reminder of preventive care measures
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.
Persuasion via anecdote
The message will contain an anecdote of a patient whose cancer was caught early through similar, recommended preventive screenings. The message prompts patients to click on a link to read the story about the patient.
Persuasion via anecdote without link
The message will contain a link to an anecdote of a patient whose cancer was caught early through similar, recommended preventive screenings. The message won't contain a link to the story, but it will briefly describe the story.
Persuasion via research
This message will mention that research has shown promptly closing health gaps saves lives.The message will contain a link to an official website that supports the statement.

Locations

Country Name City State
United States UCLA Health Department of Medicine, Quality Office Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles UCLA Health Department of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opening link within SMS Text message Percentage of participants across the different reminder arms who click on the link in the reminder message 1 week after getting the reminder
Secondary MyChart letter opened Percentage of participants across the different arms who open their personalized My Action Plan letter on MyChart 1 week after getting the reminder
Secondary Direct scheduling appointment rate 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 reminder
Secondary Rate of taking action for one overdue screening/test 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 reminder
Secondary Completion rate of one screening/test Rate of completion of at least one screening/test within the observation window. 6 months after getting the initial outreach text message
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