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Patient Portal Flu Vaccine Reminders_RCT 4

Primary Purpose

Influenza, Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message R/R with Direct Appointment Schedule Link
Text Message R/R without Direct Appointment Schedule Link
Text Pre-Appointment Reminder
Portal Message R/R with Direct Appointment Schedule Link
Portal Message R/R without Direct Appointment Schedule Link
Portal Pre-Appointment Reminder
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, Text Message, Vaccine

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

  • University of California LA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Text Message R/R with Direct Appointment Schedule Link

Text Message R/R without Direct Appointment Schedule Link

Text Message R/R with Direct Appointment Schedule Link + text Pre-Appointment Reminder

Text Message R/R without Direct Appointment Schedule Link + Text Pre-Appointment Reminder

Portal Message R/R with Direct Appointment Schedule Link

Portal Message R/R without Direct Appointment Schedule Link

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

Portal Message R/R without Direct Appointment Schedule Link + Portal Pre-Appointment Reminder

No R/R Message or Pre-Appointment Reminder

Arm Description

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 in this arm will receive up to 3 R/R messages by text with no link to schedule an appointment.

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.

Participants 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.

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 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.

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 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.

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.

Outcomes

Primary Outcome Measures

Receipt of the Annual Influenza Vaccine Among Adult Index Patients
Percent of patients with annual influenza vaccination (between 10/1/21 - 4/1/22) 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 8/1/21, 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.
Receipt of the Annual Influenza Vaccine Among Pediatric Index Patients
Percent of patients with annual influenza vaccination (between 10/1/21 - 4/1/22) 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 8/1/21, 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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2021
Last Updated
January 21, 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
NCT05052190
Brief Title
Patient Portal Flu Vaccine Reminders_RCT 4
Official Title
Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal RCT 4
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

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 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).
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 letters via the portal, 2) one-third will receive reminders via text messages sent by the health system and 3) one-third will not receive reminders. Patients in the reminder arms will be further randomized (separately) for two additional components: 1) direct appointment scheduling and 2) pre-appointment reminders. Direct scheduling: The convenience of scheduling an appointment for influenza vaccination may increase the likelihood that patients receive an influenza vaccination. Patients receiving reminders will be randomized to receive one of two types of reminder letters: 1) one half will receive flu vaccine reminder letters with a link to the MyChart direct appointment scheduling page and 2) one half will receive flu vaccine reminder message without the direct appointment scheduling link. Pre-appointment flu reminders: Finally, a missed opportunities for vaccination occurs when patients are eligible for vaccination but are not offered a vaccine at their medical appointment. Pre-appointment reminders, sent in advance of an upcoming appointment, encouraging the patient talk to their doctor about influenza vaccination, may increase the likelihood of that patient receiving a vaccine. Patients will be randomized to one of two groups: 1) one half will receive modified pre-appointment reminders that mention influenza vaccination and 2) one half will receive the standard pre-appointment reminders for an upcoming appointment (no mention of influenza vaccination). Interventions that apply Behavioral Economics principles in vaccine promotion messaging can increase vaccine receipt. We will include ownership language in the pre-appointment messages. Additionally, the convenience of reminders sent via text and with a Direct Appointment Schedule link included enables patients to self-schedule a flu vaccine only visit, reducing friction for vaccine receipt. 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. Models will contain terms for messaging modality (text v. portal v. none), pre-appointment reminders (sent v. not sent), and direct scheduling link (included v. not included). The R/R text and portal messages (with and without direct scheduling links) and pre-appointment reminders and will all begin in October of 2021.

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, Text Message, Vaccine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Pragmatic comparative effectiveness trial with a standard-of-care control group
Masking
Participant
Allocation
Randomized
Enrollment
239567 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text Message R/R with Direct Appointment Schedule Link
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Text Message R/R without Direct Appointment Schedule Link
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive up to 3 R/R messages by text with no link to schedule an appointment.
Arm Title
Text Message R/R with Direct Appointment Schedule Link + text Pre-Appointment Reminder
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Text Message R/R without Direct Appointment Schedule Link + Text Pre-Appointment Reminder
Arm Type
Active Comparator
Arm Description
Participants 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.
Arm Title
Portal Message R/R with Direct Appointment Schedule Link
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Portal Message R/R without Direct Appointment Schedule Link
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Portal Message R/R with Direct Appointment Schedule Link + Portal Pre-Appointment Reminder
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Portal Message R/R without Direct Appointment Schedule Link + Portal Pre-Appointment Reminder
Arm Type
Active Comparator
Arm Description
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 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.
Arm Title
No R/R Message or Pre-Appointment Reminder
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text Message R/R with Direct Appointment Schedule Link
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text Message R/R without Direct Appointment Schedule Link
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text Pre-Appointment Reminder
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Portal Message R/R with Direct Appointment Schedule Link
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Portal Message R/R without Direct Appointment Schedule Link
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Portal Pre-Appointment Reminder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Receipt of the Annual Influenza Vaccine Among Adult Index Patients
Description
Percent of patients with annual influenza vaccination (between 10/1/21 - 4/1/22) 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 8/1/21, 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.
Time Frame
6 months
Title
Receipt of the Annual Influenza Vaccine Among Pediatric Index Patients
Description
Percent of patients with annual influenza vaccination (between 10/1/21 - 4/1/22) 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 8/1/21, 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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Szilagyi, MPH, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California LA
City
Los Angeles
State/Province
California
ZIP/Postal Code
99095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Patient Portal Flu Vaccine Reminders_RCT 4

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