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

7. April 2022 aktualisiert von: Peter G Szilagyi, MD MPH, University of California, Los Angeles

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

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

430636

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • California
      • Los Angeles, California, Vereinigte Staaten, 99095
        • University of California LA

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

4 Monate und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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
Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Aktiver Komparator: 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
Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Aktiver Komparator: 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
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Aktiver Komparator: 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
Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Aktiver Komparator: 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
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Kein Eingriff: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Receipt of the Annual Influenza Vaccine Among Index Patients.
Zeitfenster: 6 months

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Peter G Szilagyi, MPH, MD, University of California, Los Angeles

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. Oktober 2019

Primärer Abschluss (Tatsächlich)

1. April 2020

Studienabschluss (Tatsächlich)

1. April 2020

Studienanmeldedaten

Zuerst eingereicht

27. September 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. September 2019

Zuerst gepostet (Tatsächlich)

1. Oktober 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Mai 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. April 2022

Zuletzt verifiziert

1. April 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • R01AI135029 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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