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InfluenzaNCT05525494

Patient Portal Flu Vaccine Reminders (5)

A study testing Text Fixed R/R Messages with Direct Appointment Schedule Link, Text Pre-Appointment Reminder and Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link in people with Influenza and Respiratory Tract Infections, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is taking place in Los Angeles, CA at clinics within the UCLA Health System. The study design is a 2x2 nested factorial design. Patients will be randomized into 1) receiving text based reminder messages with direct scheduling link, 2) portal-based reminder messages with direct scheduling link, or 3) the… Read more about this study

Who is it for?
Ages 6 months and older
Conditions the study is for
Influenza, Respiratory Tract Infections
What is being tested?
Text Fixed R/R Messages with Direct Appointment Schedule Link, Text Pre-Appointment Reminder and Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262,085 participants
Where
1 siteUnited States
Study dates
7 Sep 2022to 1 Apr 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Active Portal Users A patient within the UCLA Health System identified as a primary care patient per an internal algorithm

Who cannot join

  • A patient within the UCLA Health System not identified as a primary care patient per an internal algorithm

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Los Angeles

    Los Angeles, California, 99095

Other trials in United States

About this study

Official title: Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal RCT 5

This trial is taking place in Los Angeles, CA at clinics within the UCLA Health System.

The study design is a 2x2 nested factorial design. Patients will be randomized into 1) receiving text based reminder messages with direct scheduling link, 2) portal-based reminder messages with direct scheduling link, or 3) the control group. Patients randomized to the intervention arms will receive reminders if they are due for influenza vaccine.

Read more

Nested within the portal reminder arm, we will have two additional components for which patients will be randomized separately:

  1. A pre-commitment prompt, asking patients which time (September, October, November or December) and which place (UCLA, pharmacy, workplace or school, or other) they plan to get their Influenza vaccine with tailored monthly messages based on responses (pre-commitment message with tailored recall messages with direct scheduling vs. standard portal reminders with direct scheduling).
  2. 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)

Nested within the text message reminder arm, we will have one additional component for which patients will be randomized separately:

  1. 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)

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: at 6m-4.9 yrs. (70%), 5-17.9 yrs. (56%), 18-64.9 yrs. (38%), and >65 yrs. (63%). The investigators will assess the effectiveness of MyChart R/R messages and text R/R messages as compared to the standard of care control (no messages).

Read the detailed 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 do 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. Another is text messaging at the health system level.

This randomized controlled trial will assess the effectiveness of reminders messages sent to portal users, encouraging influenza vaccination, on increasing influenza vaccination rates within a health system. Patients will be randomized into three groups: 1) one-third of patients will receive reminder messages with direct scheduling and pre-appointment reminders via the portal, 2) one-third will receive reminders via text messages with direct scheduling and pre-appointment reminders sent by the health system and 3) one-third will not receive reminders.

Patients in the portal-based reminder arm will be further randomized (separately) for two additional components: pre-commitment messages with tailored recall messages and pre-appointment reminders. Patients in the text message-based reminder arm will be further randomized for an additional component: pre-appointment reminders.

Direct scheduling: The convenience of scheduling an appointment for influenza vaccination may increase the likelihood that patients receive an influenza vaccination. All patients receiving reminders (intervention groups) will receive flu vaccine reminder letters with a link to the MyChart direct appointment scheduling page.

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 in both the portal-based and text message-based reminder arms 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).

Pre-commitment prompts with tailored monthly reminders: pre-planning the place and time of the flu vaccination may improve follow-through. A pre-commitment prompt will be sent via the portal in early September asking patients to commit to a time (September, October, November or December) and place (UCLA, pharmacy, workplace or school, or other) for their flu vaccination. Tailored monthly messages will be sent to patients based on their response to the pre-commitment prompt sent in September. Patients in the portal-based reminder arm will be randomized to one of two groups: 1) one half will receive the pre-commitment prompt and tailored monthly reminders, 2) one half will receive standard monthly reminders.

Interventions that apply Behavioral Economics principles in vaccine promotion messaging can increase vaccine receipt. We will include ownership language in the pre-appointment messages. The convenience of reminders sent via text and with a Direct Appointment Schedule link included enables patients to self-schedule a flu vaccine only visit, reducing friction for vaccine receipt. Additionally, the pre-commitment prompt with tailored reminders will test the principle of implementation intention (pre-planning the place and time of the flu vaccination) has been shown in other health behavior studies to improve follow-through.

For the primary analysis, the primary outcome will be the patient's end of flu season vaccination status. Intervention effects will be assessed using mixed effects log-binomial models. Models will contain terms for messaging modality (text v. portal v. none), pre-appointment reminders (sent v. not sent), and pre-commitment prompt (sent v. not sent).

The portal-based pre-commitment prompt will be sent in September of 2022. The R/R text and portal reminder messages and pre-appointment reminders and will begin in October of 2022.

Being tested
Text Fixed R/R Messages with Direct Appointment Schedule Link, Text Pre-Appointment Reminder, Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link, Portal Fixed R/R Messages with Direct Appointment Schedule Link, Portal Pre-Appointment Reminder
Keywords
Reminder Recall (R/R), Influenza Vaccine, Electronic Health Record, Text Message, Vaccine
Medical subject headings
Influenza, Human, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Text Fixed R/R Messages with Direct Appointment Schedule LinkBehavioural

    Participants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

  • Text Pre-Appointment ReminderBehavioural

    Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period.

  • Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule LinkBehavioural

    Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

  • Portal Fixed R/R Messages with Direct Appointment Schedule LinkBehavioural

    Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

  • Portal Pre-Appointment ReminderBehavioural

    Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period.

Study groups in NCT05525494
Study groupRoleWhat they receive
Text Fixed R/R Messages with Direct Appointment Schedule Link + Text Pre-Appointment RemindersActive comparatorParticipants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period.
Receives: Behavioral: Text Fixed R/R Messages with Direct Appointment Schedule Link; Behavioral: Text Pre-Appointment Reminder
Text Fixed R/R Messages with Direct Appointment Schedule LinkActive comparatorParticipants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
Receives: Behavioral: Text Fixed R/R Messages with Direct Appointment Schedule Link
Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment RemindersActive comparatorParticipants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period.
Receives: Behavioral: Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link; Behavioral: Portal Pre-Appointment Reminder
Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule LinkActive comparatorParticipants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
Receives: Behavioral: Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link
Portal Fixed R/R Messages with Direct Appointment Schedule Link + Portal Pre-Appointment ReminderActive comparatorParticipants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period.
Receives: Behavioral: Portal Fixed R/R Messages with Direct Appointment Schedule Link; Behavioral: Portal Pre-Appointment Reminder
Portal Fixed R/R Messages with Direct Appointment Schedule LinkActive comparatorParticipants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
Receives: Behavioral: Portal Fixed R/R Messages with Direct Appointment Schedule Link
No R/R Message or Pre-Appointment ReminderNo interventionParticipants do not receive any flu vaccine R/R message or Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment during the specified flu season.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Annual Influenza Vaccine Among Index Patients

    Percent of patients with annual influenza vaccination (between 9/1/22 - 4/1/23) 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 8/1/22, 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.

    Measured: 6 months

  2. Number of Participants With Annual Influenza Vaccine Among Pediatric Index Patients

    Percent of patients with annual influenza vaccination (between 9/1/22 - 4/1/23) among pediatric 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 8/1/22, 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start7 Sep 2022
  3. Primary completion1 Apr 2023
  4. Study completion1 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
Model description
Pragmatic comparative effectiveness trial with a standard-of-care control group
Masking
Single blind
Who is masked
Participant
Enrolment
262,085 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05525494
Sponsor's protocol ID
17-001889-00016
Other IDs
R01AI135029
Status last verified
Jul 2024
First submitted
30 Aug 2022
Last updated
7 Aug 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Szilagyi PG, Duru OK, Casillas A, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Clark E, Ross MK, Evans SA, Sloyan M, Fox CR, Lerner C. Text vs Patient Portal Messaging to Improve Influenza Vaccination Coverage: A Health System-Wide Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):519-527. doi: 10.1001/jamainternmed.2024.0001.

    PubMed 38497955

Questions about this trial

What is this clinical trial studying?

A study testing Text Fixed R/R Messages with Direct Appointment Schedule Link, Text Pre-Appointment Reminder and Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link in people with Influenza and Respiratory Tract Infections, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Annual Influenza Vaccine Among Index Patients (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05525494, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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