Patient Portal - Flu Reminder Recall

Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal

This trial is taking place in Los Angeles, CA at clinics 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: 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 and cost-effectiveness of 1, 2, 3 MyChart R/R messages as compared to the standard of care control (no messages).

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Influenza; Vaccines
• Intervention / Treatment: Behavioral: 1 MyChart R/R; Behavioral: 2 MyChart R/R; Behavioral: 3 MyChart R/R

Detailed Description

Annual epidemics of influenza cause substantial morbidity in the U.S. with up to 40,000 deaths/year and many hospitalizations, emergency and outpatient visits, and significant costs. Concerns about pandemic influenza elevate the need to prevent flu outbreaks.

Numerous studies, including Cochrane or systematic reviews, and reports by the CDC and the Task Force on Community Preventive Services, highlight 4 evidence-based strategies to raise child and adult influenza vaccination rates: 1) increase patient demand by reminder-recall or education, 2) expand patient access to influenza vaccinations (e.g., flu vaccine clinics), 3) implement provider strategies such as prompts or standing orders, and 4) use societal strategies (e.g., reducing costs).

Reminder/recall (R/R), sent by phone, mail or other modality, can improve child and adult influenza vaccination rates. However, fewer than one-fifth of pediatric or adult primary care practices utilize patient 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. Portals can theoretically improve upon phone, mail or text R/R by adding information such as web links, videos, or images, allowing patients to schedule their own visits, and linking to the medical chart to customize messages.

For this randomized control trial, the intent is to evaluate the impact of patient portal (MyChart) reminder recalls - either 1, 2, or 3 reminders versus the standard of care control group, specifically in relation to raising influenza vaccination rates among UCLA Health System's primary care patients aged 6 months and older.

The proposed design of this 4-arm RCT:

1. Standard of care control (no messages)
2. Up to 1 portal R/R messages
3. Up to 2 portal R/R messages
4. Up to 3 portal R/R messages

Hypothesis 1: >1 portal R/R will increase vaccination rates vs. no R/R. Hypothesis 2: More R/R messages will raise vaccination rates (3R/R > 2R/R > 1R/R > 0R/R).

For the primary analysis, only the data from the randomly selected index patients (1 index patient per household) will be included.

For relevant study arms, the first R/R message will be sent in October 2018.

• Study Type: Interventional
• Enrollment (Actual): 164205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

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 by the system as a primary care patient per an internal algorithm, with a documented primary care visit within the last 3 years as of 8/1/18.

Exclusion Criteria:

• A patient not identified by the UCLA Health System's internal algorithm as a primary care patient.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care control; Participants in this group will not receive any MyChart influenza vaccination reminders
Experimental: 1 MyChart R/R; Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account	Behavioral: 1 MyChart R/R; Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
Experimental: 2 MyChart R/R; Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account	Behavioral: 2 MyChart R/R; Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
Experimental: 3 MyChart R/R; Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account	Behavioral: 3 MyChart R/R; Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1.Receipt of the Annual Influenza Vaccine (Between 10/1/18 - 4/2/19) Among Index Patients. Outcomes Will be Assessed Via Vaccine Data Extraction From the Electronic Health Record and External Claims and Pharmacy Data.	Number of participants in each arm who received influenza vaccination	October 1, 2018 to April 2, 2019 during influenza vaccination season

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Peter Szilagyi, MD MPH, University of California, Los Angeles

Publications and helpful links

General Publications

• Szilagyi PG, Albertin C, Casillas A, Valderrama R, Duru OK, Ong MK, Vangala S, Tseng CH, Rand CM, Humiston SG, Evans S, Sloyan M, Lerner C. Effect of Patient Portal Reminders Sent by a Health Care System on Influenza Vaccination Rates: A Randomized Clinical Trial. JAMA Intern Med. 2020 Jul 1;180(7):962-970. doi: 10.1001/jamainternmed.2020.1602.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Actual): April 2, 2019
• Study Completion (Actual): April 2, 2019

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Influenza Vaccine; Electronic Health Record; Reminder Recall (R/R)
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Respiratory Tract Infections
• Other Study ID Numbers: 17-001889; 1R01AI135029-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Aggregate results will be prepared for publication at the end of the trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No