Clinical trial NCT03666026: Patient Portal - Flu Reminder Recall
Official title: Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Respiratory Tract Infections
Vaccines
Keywords: Reminder Recall (R/R)
Influenza Vaccine
Electronic Health Record
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2018-09-11
Enrollment: 164205
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: October 1, 2018 to April 2, 2019 during influenza vaccination season
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Peter Szilagyi, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.