Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- RCT 2

April 7, 2022 updated by: Peter G Szilagyi, MD MPH, University of California, Los Angeles

Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal- RCT #2

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

There has been considerable research on how best to communicate about vaccines with families. A number of studies have examined the impact of gain-framed (messages emphasizing the benefits of vaccination) versus loss-framed (messages emphasizing the risks of not getting vaccinated); however, the findings have been inconsistent across studies and by sub-population.

In addition to framing, 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. Therefore, a pre-commitment prompt is being asked of half the participants in each arm to evaluate its impact on influenza vaccination.

The purpose of this randomized controlled trial is to evaluate the impact of gain-framed and loss-framed reminder-recall messages sent via the patient portal, pre-commitment prompts sent via the patient portal, and the interactions between the two type of messages and pre-commitment on influenza vaccination among UCLA Health System's primary care patients aged 6 months and older.

The proposed design of this randomized-controlled trial is a 3 x 2 factorial design.

Standard of care control (no reminder messages, no pre-commitment prompt) No portal messages, pre-commitment prompt Gain-framed portal messages, pre-commitment prompt Gain-framed portal messages, no pre-commitment prompt Loss-framed portal messages, pre-commitment prompt Loss-framed portal messages, no pre-commitment prompt

Hyp 1. Vaccination rates will differ by receipt of no reminders, gain-framed reminders and loss-framed reminders.

1a. Vaccination rates will be higher among patients receiving gain-framed reminders than among patients receiving no reminders.

1b. Vaccination rates will be higher among patients receiving loss-framed reminders than among patients receiving no reminders.

1c. Vaccination rates will be higher among patients receiving gain-framed reminders than among patients receiving loss-framed reminders.

Hyp 2. Vaccination rates will be higher among patients receiving a pre-commitment prompt than among patients not receiving any prompt.

For relevant study arms, the first R/R messages will be sent in October 2019.

Study Type

Interventional

Enrollment (Actual)

430636

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

  • United States
    • 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

4 months 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: Gain-framed portal reminders + Pre-commitment Prompts
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-framed
Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Behavioral: Pre-commitment prompt
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Active Comparator: Gain-framed portal reminders + No pre-commitment prompt
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
Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Active Comparator: Loss-framed portal reminders + Pre-commitment prompt
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: Pre-commitment prompt
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Behavioral: Portal Reminders for Influenza Vaccination: Loss-framed
Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Active Comparator: Loss-framed portal reminders + No pre-commitment prompt
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
Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Active Comparator: No portal reminder + Pre-commitment prompt
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
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
No Intervention: No portal reminders + No pre-commitment prompt
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of the Annual Influenza Vaccine Among Index Patients.
Time Frame: 6 months

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

Collaborators and Investigators

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

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Peter G Szilagyi, MPH, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 18, 2019

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 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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