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

NCT ID: NCT04110314

Last Updated: 2022-05-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

430636 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-18

Study Completion Date

2020-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Influenza Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Portal Reminders for Influenza Vaccination: Gain-framed

Intervention Type BEHAVIORAL

Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.

Pre-commitment prompt

Intervention Type BEHAVIORAL

Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

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

Group Type ACTIVE_COMPARATOR

Portal Reminders for Influenza Vaccination: Gain-framed

Intervention Type BEHAVIORAL

Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.

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

Group Type ACTIVE_COMPARATOR

Portal Reminders for Influenza Vaccination: Loss-framed

Intervention Type BEHAVIORAL

Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.

Pre-commitment prompt

Intervention Type BEHAVIORAL

Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

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

Group Type ACTIVE_COMPARATOR

Portal Reminders for Influenza Vaccination: Loss-framed

Intervention Type BEHAVIORAL

Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.

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

Group Type ACTIVE_COMPARATOR

Pre-commitment prompt

Intervention Type BEHAVIORAL

Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Portal Reminders for Influenza Vaccination: Gain-framed

Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.

Intervention Type BEHAVIORAL

Portal Reminders for Influenza Vaccination: Loss-framed

Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.

Intervention Type BEHAVIORAL

Pre-commitment prompt

Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Peter G Szilagyi, MD MPH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter G Szilagyi, MPH, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University of California LA

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Szilagyi PG, Albertin CS, Casillas A, Valderrama R, Duru OK, Ong MK, Vangala S, Tseng CH, Humiston SG, Evans S, Sloyan M, Bogard JE, Fox CR, Lerner C. Effect of Personalized Messages Sent by a Health System's Patient Portal on Influenza Vaccination Rates: a Randomized Clinical Trial. J Gen Intern Med. 2022 Feb;37(3):615-623. doi: 10.1007/s11606-021-07023-w. Epub 2021 Sep 1.

Reference Type DERIVED
PMID: 34472020 (View on PubMed)

Lerner C, Albertin C, Casillas A, Duru OK, Ong MK, Vangala S, Humiston S, Evans S, Sloyan M, Fox CR, Bogard JE, Friedman S, Szilagyi PG. Patient Portal Reminders for Pediatric Influenza Vaccinations: A Randomized Clinical Trial. Pediatrics. 2021 Aug;148(2):e2020048413. doi: 10.1542/peds.2020-048413.

Reference Type DERIVED
PMID: 34321338 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01AI135029

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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