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

Primary Purpose

Influenza, Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Portal Reminders for Influenza Vaccination: Gain-framed
Portal Reminders for Influenza Vaccination: Loss-framed
Pre-commitment prompt
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza focused on measuring Vaccination, Reminder recall, Patient Portal

Eligibility Criteria

4 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California LA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Gain-framed portal reminders + Pre-commitment Prompts

Gain-framed portal reminders + No pre-commitment prompt

Loss-framed portal reminders + Pre-commitment prompt

Loss-framed portal reminders + No pre-commitment prompt

No portal reminder + Pre-commitment prompt

No portal reminders + No pre-commitment prompt

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Receipt of the Annual Influenza Vaccine Among Index Patients.
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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2019
Last Updated
April 7, 2022
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04110314
Brief Title
Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- RCT 2
Official Title
Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal- RCT #2
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Respiratory Tract Infections
Keywords
Vaccination, Reminder recall, Patient Portal

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
430636 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gain-framed portal reminders + Pre-commitment Prompts
Arm Type
Active Comparator
Arm Description
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
Arm Title
Gain-framed portal reminders + No pre-commitment prompt
Arm Type
Active Comparator
Arm Description
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
Arm Title
Loss-framed portal reminders + Pre-commitment prompt
Arm Type
Active Comparator
Arm Description
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
Arm Title
Loss-framed portal reminders + No pre-commitment prompt
Arm Type
Active Comparator
Arm Description
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
Arm Title
No portal reminder + Pre-commitment prompt
Arm Type
Active Comparator
Arm Description
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
Arm Title
No portal reminders + No pre-commitment prompt
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Portal Reminders for Influenza Vaccination: Gain-framed
Intervention Description
Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Intervention Type
Behavioral
Intervention Name(s)
Portal Reminders for Influenza Vaccination: Loss-framed
Intervention Description
Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Intervention Type
Behavioral
Intervention Name(s)
Pre-commitment prompt
Intervention Description
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Primary Outcome Measure Information:
Title
Receipt of the Annual Influenza Vaccine Among Index Patients.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter G Szilagyi, MPH, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California LA
City
Los Angeles
State/Province
California
ZIP/Postal Code
99095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34472020
Citation
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.
Results Reference
derived
PubMed Identifier
34321338
Citation
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.
Results Reference
derived

Learn more about this trial

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

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