NCT04533685

Brief Summary

This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System. The study design is a 2x2x2 factorial design, nested in a parallel 2-arm trial. The parallel arms are control v. reminder letter (reminder messages sent via the patient portal, reminding participants of an overdue influenza vaccine) Nested within the reminder letter arm, we will have 3 additional components:

  • 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-commitment prompt (pre-commitment prompt vs. no prompt) asking about a patient's intention to get the influenza vaccination
  • 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
213,773

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

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 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 25, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

August 26, 2020

Results QC Date

August 18, 2022

Last Update Submit

October 1, 2022

Conditions

InfluenzaRespiratory Tract Infections

Keywords

VaccinationReminder recallPatient Portal

Outcome Measures

Primary Outcomes (1)

  • Number of Index Patients Who Received Annual Influenza Vaccine

    Receipt of the annual influenza vaccination (between 8/1/20 - 4/1/21) 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 8/1/20, 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 (9)

Direct scheduling + Pre-commitment + Pre-appt reminder

ACTIVE COMPARATOR

Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling, 2) a pre-commitment prompt and 3) pre-appointment reminders that mention asking the provider for a flu vaccine

Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling linkBehavioral: Pre-Commitment PromptBehavioral: Pre-Appointment flu vaccine reminders

Direct scheduling + Pre-commitment

ACTIVE COMPARATOR

Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling and 2) a pre-commitment prompt

Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling linkBehavioral: Pre-Commitment Prompt

Direct scheduling + Pre-appt reminder

ACTIVE COMPARATOR

Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling and 2) pre-appointment reminders that mention asking the provider for a flu vaccine

Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling linkBehavioral: Pre-Appointment flu vaccine reminders

Direct scheduling

ACTIVE COMPARATOR

Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling

Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link

No direct scheduling + Pre-commitment + Pre-Appt reminder

ACTIVE COMPARATOR

Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling, 2) a pre-commitment prompt and 3) pre-appointment reminders that mention asking the provider for a flu vaccine

Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling linkBehavioral: Pre-Commitment PromptBehavioral: Pre-Appointment flu vaccine reminders

No direct scheduling + Pre-commitment

ACTIVE COMPARATOR

Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling and 2) a pre-commitment prompt

Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling linkBehavioral: Pre-Commitment Prompt

No direct scheduling + Pre-appt reminder

ACTIVE COMPARATOR

Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling and 2) pre-appointment reminders that mention asking the provider for a flu vaccine

Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling linkBehavioral: Pre-Appointment flu vaccine reminders

No direct scheduling

ACTIVE COMPARATOR

Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling for a flu vaccine appointment

Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link

Control Arm

NO INTERVENTION

Participants will not receive any reminder/recall messages regarding influenza vaccination via the patient portal or other intervention components

Interventions

Portal Reminders for Influenza Vaccination: Direct scheduling linkBEHAVIORAL

Patients receive reminder/recall messages via the patient portal to get an influenza vaccination that include a direct scheduling link, enabling the patient to directly schedule a flu vaccination only visit

Direct schedulingDirect scheduling + Pre-appt reminderDirect scheduling + Pre-commitmentDirect scheduling + Pre-commitment + Pre-appt reminder
Portal Reminders for Influenza Vaccination: No direct scheduling linkBEHAVIORAL

Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)

No direct schedulingNo direct scheduling + Pre-appt reminderNo direct scheduling + Pre-commitmentNo direct scheduling + Pre-commitment + Pre-Appt reminder
Pre-Commitment PromptBEHAVIORAL

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

Direct scheduling + Pre-commitmentDirect scheduling + Pre-commitment + Pre-appt reminderNo direct scheduling + Pre-commitmentNo direct scheduling + Pre-commitment + Pre-Appt reminder
Pre-Appointment flu vaccine remindersBEHAVIORAL

Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine

Direct scheduling + Pre-appt reminderDirect scheduling + Pre-commitment + Pre-appt reminderNo direct scheduling + Pre-appt reminderNo direct scheduling + Pre-commitment + Pre-Appt reminder

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 (1)

  • Szilagyi PG, Casillas A, Duru OK, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Ross MK, Friedman SR, Evans S, Sloyan M, Bogard JE, Fox CR, Lerner C. Evaluation of behavioral economic strategies to raise influenza vaccination rates across a health system: Results from a randomized clinical trial. Prev Med. 2023 May;170:107474. doi: 10.1016/j.ypmed.2023.107474. Epub 2023 Mar 2.

    PMID: 36870572DERIVED

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
pszilagyi@mednet.ucla.edu
310-206-6328

Study Officials

  • Peter G Szilagyi, MD, MPH

    Professor of Pediatrics

    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: A 2x2x2 factorial design, nested within a parallel 2-arm trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

August 26, 2020

First Posted

August 31, 2020

Study Start

September 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

October 25, 2022

Results First Posted

October 25, 2022

Record last verified: 2022-10

Locations

US(1)