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Patient Portal - Flu Reminder Recall

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ClinicalTrials.gov Identifier: NCT03666026
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Peter G Szilagyi, MD MPH, University of California, Los Angeles

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Influenza Respiratory Tract Infections Vaccines Behavioral: 1 MyChart R/R Behavioral: 2 MyChart R/R Behavioral: 3 MyChart R/R Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343087 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal
Actual Study Start Date : October 2, 2018
Actual Primary Completion Date : April 2, 2019
Actual Study Completion Date : April 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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.




Primary Outcome Measures :
  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. [ Time Frame: 6 months ]

    An index patient will be a randomly selected individual within an included household. The index patient must also be an active UCLA Health MyChart user (>= 1 login over the last 12 months from 8/1/18, 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 :
  1. Receipt of annual influenza vaccine (between 10/1/18 - 4/2/19) among all included patients in identified households. Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data. [ Time Frame: 6 months ]
    All enrolled study participants, excluding unaffiliated patients and infants < 4 months, will be included in this secondary analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666026


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Peter Szilagyi, MD MPH University of California, Los Angeles

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Responsible Party: Peter G Szilagyi, MD MPH, Executive Vice Chair, Clinical Research, UCLA David Geffen School of Medicine, Dept of Pediatrics, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03666026     History of Changes
Other Study ID Numbers: 17-001889
1R01AI135029-01 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate results will be prepared for publication at the end of the trial.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter G Szilagyi, MD MPH, University of California, Los Angeles:
Reminder Recall (R/R)
Influenza Vaccine
Electronic Health Record

Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
Vaccines
Immunologic Factors
Physiological Effects of Drugs