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

Influenza Clinical Trial

Official title:

Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal- RCT #2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04110314
• Other study ID #: R01AI135029
• Status: Completed
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430636
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Respiratory Tract Infections

Intervention

Behavioral:
• Portal Reminders for Influenza Vaccination: Gain-framed
Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.
• Portal Reminders for Influenza Vaccination: Loss-framed
Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.
• Pre-commitment prompt
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

Locations

Country	Name	City	State
United States	University of California LA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months