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Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- UCLA Portal R/R Influenza RCT 3

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ClinicalTrials.gov Identifier: NCT04533685
Recruitment Status : Active, not recruiting
First Posted : August 31, 2020
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Peter G Szilagyi, MD MPH, University of California, Los Angeles

Brief Summary:

This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System.

The study design is a 2x2x2 factorial design, nested in a parallel 2-arm trial. The parallel arms are control v. reminder letter (reminder messages sent via the patient portal, reminding participants of an overdue influenza vaccine)

Nested within the reminder letter arm, we will have 3 additional components:

  • A direct scheduling link within the reminder letter enabling the patient to schedule an influenza vaccine only visit (direct scheduling link vs. no direct scheduling link).
  • A pre-commitment prompt (pre-commitment prompt vs. no prompt) asking about a patient's intention to get the influenza vaccination
  • A pre-appointment reminder, encouraging patients to ask for their influenza vaccine at their upcoming appointment (pre-appointment reminder encouraging influenza vaccination vs. standard pre-appointment reminder not mentioning influenza vaccination)

Condition or disease Intervention/treatment Phase
Influenza Respiratory Tract Infections Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link Behavioral: Pre-Commitment Prompt Behavioral: Pre-Appointment flu vaccine reminders Not Applicable

Detailed Description:

This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System, using 2x2x2 factorial design, nested in a parallel 2-arm trial.

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) messages, 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.

This randomized controlled trial will assess the effectiveness of reminders messages, encouraging influenza vaccination, sent to patient portal users on increasing influenza vaccination rates within a health system by randomizing patients to two groups: 1) two-thirds of patients will receive reminder letters, 2) one-third will not receive reminders.

Patients in the reminder arm will be further randomized (separately) for three additional components: 1) direct appointment scheduling, 2) pre-commitment prompts and 3) pre-appointment reminders.

Direct scheduling: The convenience of scheduling an appointment for influenza vaccination may increase the likelihood that patients receive an influenza vaccination. Patients receiving reminders will be randomized to receive one of two types of reminder letters: 1) one half will receive flu vaccine reminder letters with a link to the MyChart direct appointment scheduling page and 2) one half will receive flu vaccine reminder message without the direct appointment scheduling link.

Pre-commitment: 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. Patients will be randomized to one of two groups: 1) one half will receive pre-commitment prompt at the beginning of influenza vaccination season and 2) one half will not receive a pre-commitment prompt. The pre-commitment prompt asks whether the patient intends to receive influenza vaccine, and where and when they plan to get the vaccine.

Pre-appointment flu reminders: Finally, a missed opportunities for vaccination occurs when patients are eligible for vaccination but are not offered a vaccine at their medical appointment. Pre-appointment reminders, sent in advance of an upcoming appointment, encouraging the patient talk to their doctor about influenza vaccination, may increase the likelihood of that patient receiving a vaccine. Patients will be randomized to one of two groups: 1) one half will receive modified pre-appointment reminders that mention influenza vaccination and 2) one half will receive the standard pre-appointment reminders for an upcoming appointment (no mention of influenza vaccination).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213773 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: A 2x2x2 factorial design, nested within a parallel 2-arm trial.
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- RCT 3
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Direct scheduling + Pre-commitment + Pre-appt reminder
Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling, 2) a pre-commitment prompt and 3) pre-appointment reminders that mention asking the provider for a flu vaccine
Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination that include a direct scheduling link, enabling the patient to directly schedule a flu vaccination only visit

Behavioral: Pre-Commitment Prompt
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

Behavioral: Pre-Appointment flu vaccine reminders
Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine

Active Comparator: Direct scheduling + Pre-commitment
Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling and 2) a pre-commitment prompt
Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination that include a direct scheduling link, enabling the patient to directly schedule a flu vaccination only visit

Behavioral: Pre-Commitment Prompt
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

Active Comparator: Direct scheduling + Pre-appt reminder
Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling and 2) pre-appointment reminders that mention asking the provider for a flu vaccine
Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination that include a direct scheduling link, enabling the patient to directly schedule a flu vaccination only visit

Behavioral: Pre-Appointment flu vaccine reminders
Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine

Active Comparator: Direct scheduling
Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling
Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination that include a direct scheduling link, enabling the patient to directly schedule a flu vaccination only visit

Active Comparator: No direct scheduling + Pre-commitment + Pre-Appt reminder
Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling, 2) a pre-commitment prompt and 3) pre-appointment reminders that mention asking the provider for a flu vaccine
Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)

Behavioral: Pre-Commitment Prompt
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

Behavioral: Pre-Appointment flu vaccine reminders
Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine

Active Comparator: No direct scheduling + Pre-commitment
Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling and 2) a pre-commitment prompt
Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)

Behavioral: Pre-Commitment Prompt
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination

Active Comparator: No direct scheduling + Pre-appt reminder
Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling and 2) pre-appointment reminders that mention asking the provider for a flu vaccine
Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)

Behavioral: Pre-Appointment flu vaccine reminders
Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine

Active Comparator: No direct scheduling
Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling for a flu vaccine appointment
Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)

No Intervention: Control Arm
Participants will not receive any reminder/recall messages regarding influenza vaccination via the patient portal or other intervention components



Primary Outcome Measures :
  1. Number of index patients who received annual influenza vaccine [ Time Frame: 6 months ]

    Receipt of the annual influenza vaccination (between 8/1/20 - 4/1/21) among index patients. Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data.

    The index patients must also be an active UCLA Health MyChart user (>= 1 login over the last 12 months from 8/1/20, 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533685


Locations
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United States, California
University of California LA
Los Angeles, California, United States, 99095
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Peter G Szilagyi, MD, MPH Professor of Pediatrics
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Responsible Party: Peter G Szilagyi, MD MPH, Professor of Pediatrics, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04533685    
Other Study ID Numbers: 17-001889-AM-00012
R01AI135029 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter G Szilagyi, MD MPH, University of California, Los Angeles:
Vaccination
Reminder recall
Patient Portal
Additional relevant MeSH terms:
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Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
Vaccines
Immunologic Factors
Physiological Effects of Drugs