Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- UCLA Portal R/R Influenza RCT 3

October 1, 2022 updated by: Peter G Szilagyi, MD MPH, University of California, Los Angeles

Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- RCT 3

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)

Study Overview

Detailed Description

This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System, using 2x2x2 factorial design, nested in a parallel 2-arm trial.

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) messages, 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 to 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.

This randomized controlled trial will assess the effectiveness of reminders messages, encouraging influenza vaccination, sent to patient portal users on increasing influenza vaccination rates within a health system by randomizing patients to two groups: 1) two-thirds of patients will receive reminder letters, 2) one-third will not receive reminders.

Patients in the reminder arm will be further randomized (separately) for three additional components: 1) direct appointment scheduling, 2) pre-commitment prompts and 3) 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-commitment: Another potential influence on the decision to vaccinate is pre-commitment. Previous studies suggest that, upon being prompted, indicating an intention to do something increases the likelihood of following through. Patients will be randomized to one of two groups: 1) one half will receive pre-commitment prompt at the beginning of influenza vaccination season and 2) one half will not receive a pre-commitment prompt. The pre-commitment prompt asks whether the patient intends to receive influenza vaccine, and where and when they plan to get the vaccine.

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).

Study Type

Interventional

Enrollment (Actual)

213773

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 99095
        • University of California LA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Direct scheduling + Pre-commitment + Pre-appt reminder
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
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
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine
Active Comparator: Direct scheduling + Pre-commitment
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
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
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Active Comparator: Direct scheduling + Pre-appt reminder
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
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
Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine
Active Comparator: Direct scheduling
Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling
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
Active Comparator: No direct scheduling + Pre-commitment + Pre-Appt reminder
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
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)
Active Comparator: No direct scheduling + Pre-commitment
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
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)
Active Comparator: No direct scheduling + Pre-appt reminder
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
Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)
Active Comparator: No direct scheduling
Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling for a flu vaccine appointment
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)
No Intervention: Control Arm
Participants will not receive any reminder/recall messages regarding influenza vaccination via the patient portal or other intervention components

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Index Patients Who Received Annual Influenza Vaccine
Time Frame: 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Peter G Szilagyi, MD, MPH, Professor of Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 17-001889-AM-00012
  • R01AI135029 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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