NCT04110314

Brief Summary

This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System. 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. The investigators will assess the effectiveness of message-framing (gain-framed, loss-framed messages, no messages), as well as the effectiveness of a pre-commitment prompt (pre-commitment prompt, no prompt) asking about a patient's intention to get the influenza vaccination, using a 3 x 2 factorial design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
430,636

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

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

September 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

October 18, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 31, 2022

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

September 27, 2019

Results QC Date

July 13, 2021

Last Update Submit

April 7, 2022

Conditions

Keywords

VaccinationReminder recallPatient Portal

Outcome Measures

Primary Outcomes (1)

  • Receipt of the Annual Influenza Vaccine Among Index Patients.

    Receipt of the annual influenza vaccination (between 10/2/19 - 4/1/20) among index patients. Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data. Index patients will be randomly selected individuals within an included household, eligible for the following groups (\<18, 18-64 non-diabetic, 65+ non-diabetic, and 18+ diabetic). One index patient per group may be selected from each household. The index patients must also be an active UCLA Health MyChart user (\>= 1 login over the last 12 months from 8/1/19, 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 (6)

Gain-framed portal reminders + Pre-commitment Prompts

ACTIVE COMPARATOR

Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season

Behavioral: Portal Reminders for Influenza Vaccination: Gain-framedBehavioral: Pre-commitment prompt

Gain-framed portal reminders + No pre-commitment prompt

ACTIVE COMPARATOR

Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season

Behavioral: Portal Reminders for Influenza Vaccination: Gain-framed

Loss-framed portal reminders + Pre-commitment prompt

ACTIVE COMPARATOR

Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season

Behavioral: Portal Reminders for Influenza Vaccination: Loss-framedBehavioral: Pre-commitment prompt

Loss-framed portal reminders + No pre-commitment prompt

ACTIVE COMPARATOR

Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season

Behavioral: Portal Reminders for Influenza Vaccination: Loss-framed

No portal reminder + Pre-commitment prompt

ACTIVE COMPARATOR

Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal but do receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season

Behavioral: Pre-commitment prompt

No portal reminders + No pre-commitment prompt

NO INTERVENTION

Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal and do not receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season

Interventions

Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.

Gain-framed portal reminders + No pre-commitment promptGain-framed portal reminders + Pre-commitment Prompts

Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.

Loss-framed portal reminders + No pre-commitment promptLoss-framed portal reminders + Pre-commitment prompt

Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

Gain-framed portal reminders + Pre-commitment PromptsLoss-framed portal reminders + Pre-commitment promptNo portal reminder + Pre-commitment prompt

Eligibility Criteria

Age4 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Location

Related Publications (2)

  • Szilagyi PG, Albertin CS, Casillas A, Valderrama R, Duru OK, Ong MK, Vangala S, Tseng CH, Humiston SG, Evans S, Sloyan M, Bogard JE, Fox CR, Lerner C. Effect of Personalized Messages Sent by a Health System's Patient Portal on Influenza Vaccination Rates: a Randomized Clinical Trial. J Gen Intern Med. 2022 Feb;37(3):615-623. doi: 10.1007/s11606-021-07023-w. Epub 2021 Sep 1.

  • Lerner C, Albertin C, Casillas A, Duru OK, Ong MK, Vangala S, Humiston S, Evans S, Sloyan M, Fox CR, Bogard JE, Friedman S, Szilagyi PG. Patient Portal Reminders for Pediatric Influenza Vaccinations: A Randomized Clinical Trial. Pediatrics. 2021 Aug;148(2):e2020048413. doi: 10.1542/peds.2020-048413.

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 G Szilagyi, MPH, MD

    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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 1, 2019

Study Start

October 18, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 5, 2022

Results First Posted

March 31, 2022

Record last verified: 2022-04

Locations