NCT05525494

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 with direct scheduling link, 2) portal-based reminder messages with direct scheduling link, or 3) the control group. Patients randomized to the intervention arms will receive reminders if they are due for influenza vaccine. Nested within the portal reminder arm, we will have two additional components for which patients will be randomized separately:

  1. 1.A pre-commitment prompt, asking patients which time (September, October, November or December) and which place (UCLA, pharmacy, workplace or school, or other) they plan to get their Influenza vaccine with tailored monthly messages based on responses (pre-commitment message with tailored recall messages with direct scheduling vs. standard portal reminders with direct scheduling).
  2. 2.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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262,085

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 30, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

September 7, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

August 30, 2022

Results QC Date

March 26, 2024

Last Update Submit

July 11, 2024

Conditions

Keywords

Reminder Recall (R/R)Influenza VaccineElectronic Health RecordText MessageVaccine

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Annual Influenza Vaccine Among Index Patients

    Percent of patients with annual influenza vaccination (between 9/1/22 - 4/1/23) among 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 8/1/22, 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

  • Number of Participants With Annual Influenza Vaccine Among Pediatric Index Patients

    Percent of patients with annual influenza vaccination (between 9/1/22 - 4/1/23) among 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 8/1/22, 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

Study Arms (7)

Text Fixed R/R Messages with Direct Appointment Schedule Link + Text Pre-Appointment Reminders

ACTIVE COMPARATOR

Participants 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.

Behavioral: Text Fixed R/R Messages with Direct Appointment Schedule LinkBehavioral: Text Pre-Appointment Reminder

Text Fixed R/R Messages with Direct Appointment Schedule Link

ACTIVE COMPARATOR

Participants 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.

Behavioral: Text Fixed R/R Messages with Direct Appointment Schedule Link

Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders

ACTIVE COMPARATOR

Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). 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.

Behavioral: Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule LinkBehavioral: Portal Pre-Appointment Reminder

Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link

ACTIVE COMPARATOR

Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

Behavioral: Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link

Portal Fixed R/R Messages with Direct Appointment Schedule Link + Portal Pre-Appointment Reminder

ACTIVE COMPARATOR

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 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.

Behavioral: Portal Fixed R/R Messages with Direct Appointment Schedule LinkBehavioral: Portal Pre-Appointment Reminder

Portal Fixed R/R Messages with Direct Appointment Schedule Link

ACTIVE COMPARATOR

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.

Behavioral: Portal Fixed R/R Messages with Direct Appointment Schedule Link

No R/R Message or Pre-Appointment Reminder

NO INTERVENTION

Participants 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. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

Text Fixed R/R Messages with Direct Appointment Schedule LinkText Fixed R/R Messages with Direct Appointment Schedule Link + Text Pre-Appointment Reminders

Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period.

Text Fixed R/R Messages with Direct Appointment Schedule Link + Text Pre-Appointment Reminders

Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule LinkPortal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders

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.

Portal Fixed R/R Messages with Direct Appointment Schedule LinkPortal Fixed R/R Messages with Direct Appointment Schedule Link + Portal Pre-Appointment Reminder

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 Fixed R/R Messages with Direct Appointment Schedule Link + Portal Pre-Appointment ReminderPortal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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, Los Angeles

Los Angeles, California, 99095, United States

Location

Related Publications (1)

  • Szilagyi PG, Duru OK, Casillas A, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Clark E, Ross MK, Evans SA, Sloyan M, Fox CR, Lerner C. Text vs Patient Portal Messaging to Improve Influenza Vaccination Coverage: A Health System-Wide Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):519-527. doi: 10.1001/jamainternmed.2024.0001.

MeSH Terms

Conditions

Influenza, HumanRespiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Principal Investigator
Organization
UCLA

Study Officials

  • Peter Szilagyi, MD, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

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
Model Details: Pragmatic comparative effectiveness trial with a standard-of-care control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Vice Chair, Vice Chair for Research, UCLA David Geffen School of Medicine, Department of Pediatrics, University of California, Los Angeles

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 1, 2022

Study Start

September 7, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

August 7, 2024

Results First Posted

August 7, 2024

Record last verified: 2024-07

Locations