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

Study Overview
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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.

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

Conditions
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Influenza, Respiratory Tract Infections

Intervention / Treatment
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* Behavioral: Portal Reminders for Influenza Vaccination: Gain-framed
* Behavioral: Portal Reminders for Influenza Vaccination: Loss-framed
* Behavioral: Pre-commitment prompt


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gain-framed portal reminders + Pre-commitment Prompts<br>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 | Behavioral: Portal Reminders for Influenza Vaccination: Gain-framed<br>* Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.<br>Behavioral: Pre-commitment prompt<br>* Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination<br>|
| Active Comparator: Gain-framed portal reminders + No pre-commitment prompt<br>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 | Behavioral: Portal Reminders for Influenza Vaccination: Gain-framed<br>* Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.<br>|
| Active Comparator: Loss-framed portal reminders + Pre-commitment prompt<br>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 | Behavioral: Portal Reminders for Influenza Vaccination: Loss-framed<br>* Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.<br>Behavioral: Pre-commitment prompt<br>* Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination<br>|
| Active Comparator: Loss-framed portal reminders + No pre-commitment prompt<br>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 | Behavioral: Portal Reminders for Influenza Vaccination: Loss-framed<br>* Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.<br>|
| Active Comparator: No portal reminder + Pre-commitment prompt<br>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 | Behavioral: Pre-commitment prompt<br>* Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination<br>|
| No Intervention: No portal reminders + No pre-commitment prompt<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination, Reminder recall, Patient Portal