Patient Portal Flu Vaccine Reminders_RCT 5 (LADHS)

NCT ID: NCT05535777

Last Updated: 2025-04-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

246295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

The study design is a comparative effectiveness trial design. Patients will be randomized into 1) receiving enhanced texting with a callback by a trained call-center staff member to schedule a vaccine visit if the patient presses "1" in response to the text, 2) receiving enhanced bidirectional texting with a texting response from a trained call-center staff member who will help the patient schedule a vaccine visit through a series of back-and-forth texts, or 3) standard text reminders (control group). Patients in all arms will receive reminders if they are due for influenza vaccine.

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 enhanced text R/R messages as compared to the standard of care control (standard text reminders).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 text messaging at the health system level.

This randomized controlled trial will assess the effectiveness of reminders messages sent by text 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 enhanced text reminder messages, 2) one-third will receive enhanced bidirectional text reminder messages and 3) one-third will received standard-of-care text reminder messages.

Enhanced texts - Callback by a person: Patient randomized to this study arm will receive a phone call back by a call center agent if they press "1" in response to a question on the original text message. The call center agent's job is to schedule patients for clinical visits. These call center agents will be trained by our faculty and staff and will have the usual HIPAA and other patient confidentiality training.

Enhanced Bidirectional Texts: These texts are designed to help schedule a vaccine visit. Patients randomized to this study arm will receive a text message from a call center agent if they press "1" in response to a question on the original text message. The bidirectional texts will have an agent who can answer questions and schedule an appointment through text message back-and-forth conversations with the patient. Bidirectional texts will be exchanged on a HIPAA compliant bidirectional text messaging platform. The patient will use the regular SMS function on their cellphone and the agent will receive and respond to the bidirectional text on the HIPAA compliant platform.

Previous studies have shown that low-cost, behavioral nudges through texting can increase influenza vaccination uptake compared to usual care. However, there are limited studies that evaluate the effect of decreasing friction/barriers to scheduling especially within safety net populations. This study will examine the effect of strategies to reduce friction/barriers to scheduling including bidirectional text messages, and texts for patients to call for direct scheduling without wait time on influenza vaccination rates in adults within the 2022-2023 flu season.

For the primary analysis, the primary outcome will be the patient's end of flu season vaccination status. Intervention effects will be assessed using multivariable log-binomial regression models. Regressions will include indicators for each intervention as fixed effects, with the standard text condition as the reference group, and potentially clinic random effects, depending on retrospective analysis results. Models will also adjust for patient age, gender, race/ethnicity, insurance, and whether the patient was vaccinated in at least one of the prior two flu seasons.

The enhanced texts with callback, enhanced bidirectional texts, and standard-of-care text reminder messages will begin in September of 2022.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza Respiratory Tract Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic comparative effectiveness trial with a standard-of-care control group
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Enhanced Text Reminders with Callback by Person

Participants in this arm will receive up to 3 R/R messages by text. R/R message will receive a phone call back by a call center agent if they press "1" in response to a question on the original text message. The call center agent's job is to schedule patients for clinical visits. These call center agents will be trained by our faculty and staff and will have the usual HIPAA and other patient confidentiality training.

Group Type ACTIVE_COMPARATOR

Enhanced texts with Callback by a Person

Intervention Type BEHAVIORAL

Enhanced texts - Callback by a person: Patient randomized to this study arm will receive a phone call back by a call center agent if they press "1" in response to a question on the original text message. The call center agent's job is to schedule patients for clinical visits. These call center agents will be trained by our faculty and staff and will have the usual HIPAA and other patient confidentiality training.

Enhanced Bidirectional Text Reminders

Participants in this arm will receive a text message from a call center agent if they press "1" in response to a question on the original text message. The bidirectional texts will have an agent who can answer questions and schedule an appointment through text message back-and-forth conversations with the patient. Bidirectional texts will be exchanged on a HIPAA compliant bidirectional text messaging platform. The patient will use the regular SMS function on their cellphone and the agent will receive and respond to the bidirectional text on the HIPAA compliant platform.

Group Type ACTIVE_COMPARATOR

Enhanced Bidirectional Texts

Intervention Type BEHAVIORAL

Patients randomized to this study arm will receive a text message from a call center agent if they press "1" in response to a question on the original text message. The bidirectional texts will have an agent who can answer questions and schedule an appointment through text message back-and-forth conversations with the patient.

Standard Text Reminders

Participants in this arm will receive up to 3 text messages, reminding them about the importance of influenza vaccination. The standard texts will include a clinic call back number and patient portal self-scheduling for patients to schedule their influenza vaccines. The direct scheduling texts includes a direct number to an agent that can help schedule and answer questions on the phone in real time. The texts with a direct number to schedule will link a specified phone number to call and schedule. This number would be answered by a central agent quickly and a patient could schedule their flu shot at any clinic site. This specific phone number would not go through the multiple option menus a patient would normally experience when calling their clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Enhanced texts with Callback by a Person

Enhanced texts - Callback by a person: Patient randomized to this study arm will receive a phone call back by a call center agent if they press "1" in response to a question on the original text message. The call center agent's job is to schedule patients for clinical visits. These call center agents will be trained by our faculty and staff and will have the usual HIPAA and other patient confidentiality training.

Intervention Type BEHAVIORAL

Enhanced Bidirectional Texts

Patients randomized to this study arm will receive a text message from a call center agent if they press "1" in response to a question on the original text message. The bidirectional texts will have an agent who can answer questions and schedule an appointment through text message back-and-forth conversations with the patient.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* LADHS patients identified as primary care patients assigned as follows: (1) assigned through managed care plans, (2) self-pay but linked with a provider, or (3) uninsured but assigned.

Exclusion Criteria

* LADHS patient not identified as a primary care patient.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Los Angeles County Department of Public Health

OTHER_GOV

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter G Szilagyi, MD MPH

Executive Vice Chair, Vice Chair for Research, UCLA David Geffen School of Medicine, Department of Pediatrics, University of California, Los Angeles

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Szilagyi

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Los Angeles County Department of Health Services

Los Angeles, California, United States

Site Status

University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AI135029

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-001889-00016 (LADHS)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Influenza Reminder Text-Messaging
NCT06587984 COMPLETED NA