- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04110314
Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- RCT 2
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
California
-
Los Angeles, California, Spojené státy, 99095
- University of California LA
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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
|
|
Aktivní komparátor: 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.
|
|
Aktivní komparátor: 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.
|
|
Aktivní komparátor: 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.
|
|
Aktivní komparátor: 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
|
|
Žádný zásah: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Receipt of the Annual Influenza Vaccine Among Index Patients.
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Peter G Szilagyi, MPH, MD, University of California, Los Angeles
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R01AI135029 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Infekce dýchacích cest
-
Onze Lieve Vrouw HospitalUniversiteit Antwerpen; MSD Belgium BVBADokončenoRespirator-Gated Imaging TechnikyBelgie
-
Biostime Institute of Nutrition and CareDokončeno
-
Maastricht University Medical CenterWingate Institute of NeurogastroenterologyNáborfMRI | Transkutánní stimulace vagového nervu (tVNS) | Nucleus of the Solitary Tract (NTS)Holandsko, Spojené království
-
Assiut UniversityZatím nenabírámeGIT - Gastrointestinal Tract Hemorrhage
-
Assiut UniversityNeznámýCKD | GIT - Gastrointestinal Tract Hemorrhage
-
Kevin WinthropAN2 Therapeutics, IncNáborInfekce Mycobacterium AbscessusSpojené státy
-
Beijing Chest HospitalZápis na pozvánkuInfekce Mycobacterium Abscessus | MonoterapieČína
-
Beijing Chest HospitalZápis na pozvánkuInfekce Mycobacterium Abscessus | NTM plicní infekce způsobená MACČína
-
Institute of Tropical Medicine, BelgiumDamien FoundationDokončeno
-
London School of Hygiene and Tropical MedicineArmauer Hansen Research Institute, Ethiopia; Alert Hospital, Ethiopia; Homes...Dokončeno