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Patient Portal Flu Vaccine Reminders (RCT 6)

Primary Purpose

Influenza, Respiratory Tract Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Portal-based Video Message
Portal-based Infographic Message
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza focused on measuring Reminder Recall (R/R), Influenza Vaccine, Electronic Health Record, Vaccine, Video Messages, Trusted Messenger

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Active Portal Users A patient within the UCLA Health System identified as a primary care patient per an internal algorithm Exclusion Criteria: - A patient within the UCLA Health System not identified as a primary care patient per an internal algorithm

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Portal-Based PCP Video Reminder Message

    Portal-Based PCP Infographic Reminder Message

    Standard Health System Portal Messages

    Arm Description

    Participants in their arm will receive up to 3 portal-based messages with a video recorded message from their own primary care physician encouraging them to receive the influenza vaccine.

    Participants in their arm will receive up to 3 portal-based messages with an infographic message with an image of their own primary care physician encouraging them to receive the influenza vaccine.

    Participants in this arm will only receive standard-of-care health system portal messages, and will not receive study-based messages.

    Outcomes

    Primary Outcome Measures

    Receipt of the Annual Influenza Vaccine Among Adult Index Patients
    Percent of patients with annual influenza vaccination (between 10/4/23 - 4/1/24) among adult 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 8/1/23, 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.
    Receipt of the Annual Influenza Vaccine Among Pediatric Index Patients
    Percent of patients with annual influenza vaccination (between 10/4/23 - 4/1/24) 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 8/1/23, 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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    September 25, 2023
    Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06062264
    Brief Title
    Patient Portal Flu Vaccine Reminders (RCT 6)
    Official Title
    Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal RCT 6
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This trial is taking place in Los Angeles, CA at 21 clinics within the UCLA Health System. The study design is a 3 arm randomized trial. Patients will be randomized into 1) receiving portal based reminder messages with a video from their PCP encouraging them to receive the influenza vaccine, 2) portal-based reminder messages with an infographic with the image of their PCP encouraging them to receive the influenza vaccine, or 3) the control group. Patients randomized to the intervention arms will receive reminders if they are due for influenza vaccine. 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 video messages and infographic messages as compared to the standard of care control (Health system messages).
    Detailed Description
    Sub-optimal vaccination rates are a significant problem in the U.S., despite their effectiveness in preventing morbidity and mortality from vaccine-preventable illness. For influenza specifically, annual epidemics of influenza cause substantial morbidity in the U.S. with up to 40,00-80,000 deaths/year and many hospitalizations, emergency and outpatient visits, and significant costs. Reminder/recall (R/R), sent by phone, mail or other modality, can improve child and adult influenza vaccination rates. However, the majority of pediatric or adult primary care practices do not conduct R/R. Barriers are lack of finances, personnel, and algorithms to identify eligible patients. A technological breakthrough that might overcome these barriers involves patient portals-- secure, web-based communication systems, embedded within electronic health records (EHRs), for patients and providers to communicate with each other via email and the internet. Portals are used by about half of Americans and half of UCLA patients. Another is text messaging at the health system level. This randomized controlled trial will assess the effectiveness of reminders messages sent to portal users, encouraging influenza vaccination, on increasing influenza vaccination rates within a health system. Patients will be randomized into three groups: 1) one-third of patients will receive reminder messages with a video from their PCP encouraging them to receive the influenza vaccine, 2) one-third will receive reminders with an infographic with information about the influenza vaccine with an image of their PCP, and 3) one-third will receive standard health system messages (standard of care). Portal-based video messages: Clinicians have been shown to be trusted by their patients, so by sending patients videos that have been recorded by their own primary care physician, we are testing the concept of 'trusted messengers' to improve influenza vaccine uptake. Portal-based infographic messages: This study arm is also testing the concept of 'trusted messenger' since all infographic messages will also have an image of patients' own primary care physician at the top. Interventions that apply Behavioral Economics principles in vaccine promotion messaging can increase vaccine receipt. In the physician videos and infographics we will also include language utilizing the concepts endorsing social norms, social good, positive framing, urgency, and planning. For the primary analysis, the primary outcome will be the patient's end of flu season vaccination status. Intervention effects will be assessed using mixed effects log-binomial models. The portal-based reminder messages will be sent in October of 2023. Repeat messages will also be sent in late October, and late November to patients who do not receive their influenza vaccines.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza, Respiratory Tract Infections
    Keywords
    Reminder Recall (R/R), Influenza Vaccine, Electronic Health Record, Vaccine, Video Messages, Trusted Messenger

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Pragmatic comparative effectiveness trial with a standard-of-care control group
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    22233 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Portal-Based PCP Video Reminder Message
    Arm Type
    Active Comparator
    Arm Description
    Participants in their arm will receive up to 3 portal-based messages with a video recorded message from their own primary care physician encouraging them to receive the influenza vaccine.
    Arm Title
    Portal-Based PCP Infographic Reminder Message
    Arm Type
    Active Comparator
    Arm Description
    Participants in their arm will receive up to 3 portal-based messages with an infographic message with an image of their own primary care physician encouraging them to receive the influenza vaccine.
    Arm Title
    Standard Health System Portal Messages
    Arm Type
    No Intervention
    Arm Description
    Participants in this arm will only receive standard-of-care health system portal messages, and will not receive study-based messages.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Portal-based Video Message
    Intervention Description
    Video recorded by physician encouraging patients to receive influenza vaccine. Sent via the patient portal.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Portal-based Infographic Message
    Intervention Description
    Infographic with information about the influenza vaccine and an image of the physician. Sent via the patient portal.
    Primary Outcome Measure Information:
    Title
    Receipt of the Annual Influenza Vaccine Among Adult Index Patients
    Description
    Percent of patients with annual influenza vaccination (between 10/4/23 - 4/1/24) among adult 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 8/1/23, 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.
    Time Frame
    6 months
    Title
    Receipt of the Annual Influenza Vaccine Among Pediatric Index Patients
    Description
    Percent of patients with annual influenza vaccination (between 10/4/23 - 4/1/24) 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 8/1/23, 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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Active Portal Users A patient within the UCLA Health System identified as a primary care patient per an internal algorithm Exclusion Criteria: - A patient within the UCLA Health System not identified as a primary care patient per an internal algorithm
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peter Szilagyi, MD, MPH
    Phone
    310-206-6328
    Email
    pszilagyi@mednet.ucla.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emma Clark, MSc
    Phone
    2154324686
    Email
    ejclark@mednet.ucla.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter Szilagyi, MD, MPH
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Patient Portal Flu Vaccine Reminders (RCT 6)

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