Study Stopped
IT error which contaminated study arms
Patient Portal Flu Vaccine Reminders_RCT 4
Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal RCT 4
2 other identifiers
interventional
239,567
1 country
1
Brief Summary
This trial is taking place in Los Angeles, CA at clinics within the UCLA Health System. The study design is a 2x2 nested factorial design. Patients will be randomized into 1) receiving text based reminder messages, 2) portal-based reminder messages or 3) the control group. Patients randomized to the intervention arms will receive reminders if they are due for influenza vaccine. Nested within the reminder arms (text or portal), we will have 2 additional components for which patients will be randomized separately:
- A direct scheduling link within the reminder letter enabling the patient to schedule an influenza vaccine only visit (direct scheduling link vs. no direct scheduling link).
- A pre-appointment reminder, encouraging patients to ask for their influenza vaccine at their upcoming appointment (pre-appointment reminder encouraging influenza vaccination vs. standard pre-appointment reminder not mentioning influenza vaccination) Despite the Advisory Committee on Immunization Practices (ACIP) recommendation in 2010 that all people above 6 months of age should receive an annual flu vaccine, vaccination rates remain low: at 6m-4.9 yrs. (70%), 5-17.9 yrs. (56%), 18-64.9 yrs. (38%), and \>65 yrs. (63%). The investigators will assess the effectiveness of MyChart R/R messages and text R/R messages as compared to the standard of care control (no messages).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 22, 2021
CompletedStudy Start
First participant enrolled
October 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedResults Posted
Study results publicly available
April 11, 2025
CompletedApril 11, 2025
March 1, 2025
6 months
August 31, 2021
December 12, 2024
March 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Receipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients
Percent of patients with annual influenza vaccination (between 10/1/21 - 4/1/22) among adult and pediatric index patients. Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data. The index patients must also be an active UCLA Health MyChart user (\>= 1 login over the last 12 months from 8/1/21, excluding activity on the user's initial profile activation date). Individuals not affiliated with any primary care practice will be excluded from the primary analysis.
6 months
Other Outcomes (1)
Receipt of the Annual Influenza Vaccine Among Pediatric Index Patients
6 months - Unable to analyze data due to contaminated study arms
Study Arms (9)
Text Message R/R with Direct Appointment Schedule Link
ACTIVE COMPARATORParticipants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
Text Message R/R without Direct Appointment Schedule Link
ACTIVE COMPARATORParticipants in this arm will receive up to 3 R/R messages by text with no link to schedule an appointment.
Text Message R/R with Direct Appointment Schedule Link + text Pre-Appointment Reminder
ACTIVE COMPARATORParticipants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period.
Text Message R/R without Direct Appointment Schedule Link + Text Pre-Appointment Reminder
ACTIVE COMPARATORParticipants in this arm will receive up to 3 R/R messages by text. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period.
Portal Message R/R with Direct Appointment Schedule Link
ACTIVE COMPARATORParticipants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
Portal Message R/R without Direct Appointment Schedule Link
ACTIVE COMPARATORParticipants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
Portal Message R/R with Direct Appointment Schedule Link + Portal Pre-Appointment Reminder
ACTIVE COMPARATORParticipants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period.
Portal Message R/R without Direct Appointment Schedule Link + Portal Pre-Appointment Reminder
ACTIVE COMPARATORParticipants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period.
No R/R Message or Pre-Appointment Reminder
NO INTERVENTIONParticipants do not receive any flu vaccine R/R message or Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment during the specified flu season.
Interventions
Participants in this arm will receive up to 3 R/R messages by text reminding them to get a flu vaccine with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
Participants in this arm will receive up to 3 R/R messages by text reminding them to get a flu vaccine without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period advising them to get the flu vaccine at their upcoming appointment.
Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
Participants will receive a Pre-Appointment Reminder via the portal advising them to ask their doctor for the flu vaccine at their upcoming appointment via text when they schedule a visit during the study period.
Eligibility Criteria
You may qualify if:
- Active Portal Users A patient within the UCLA Health System identified as a primary care patient per an internal algorithm
You may not qualify if:
- A patient within the UCLA Health System not identified as a primary care patient per an internal algorithm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California LA
Los Angeles, California, 99095, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Errors occurred with the text messaging component of our studying meaning that over half of the cohort that was randomized to receive the intervention did not receive the allocated messages. For this reason, our study team terminated the study early and had no intention of ever publishing these results but instead planned to repeat the trial correctly. Outcome results reported are not valid and have not been published
Results Point of Contact
- Title
- Principal Investigator
- Organization
- UCLA
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Szilagyi, MPH, MD
University of California, Los Angeles
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Vice Chair, Clinical Research, UCLA David Geffen School of Medicine, Dept of Pediatrics, University of California, Los Angeles
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 22, 2021
Study Start
October 14, 2021
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
April 11, 2025
Results First Posted
April 11, 2025
Record last verified: 2025-03