Patient Portal Flu Vaccine Reminders_RCT 5 (LADHS)

NCT05535777 | Completed Results

• 2 other identifiers: 17-001889-00016 (LADHS)R01AI135029
• Study Type: interventional
• Target: 246,295
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Influenza; Respiratory Tract Infections

Keywords

Reminder Recall (R/R); Influenza Vaccine; Electronic Health Record; Text Message; Vaccine

Outcome Measures

Primary Outcomes (1)

• Receipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients

  Percent of patients with annual influenza vaccination (between 9/1/22 - 4/1/23) among adult and 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 be an LADHS patient. Primary care patients who are empaneled to a primary care provider within DHS are assigned as follows: (1) assigned through managed care plans, (2) self-pay but linked with a provider or (3) uninsured but assigned). Individuals not affiliated with any primary care practice will be excluded from the primary analysis.

  6 months

Secondary Outcomes (1)

• Receipt of the Annual Influenza Vaccine Among Pediatric Index Patients

  6 months

Study Arms (3)

Enhanced Text Reminders with Callback by Person

ACTIVE COMPARATOR

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.

Behavioral: Enhanced texts with Callback by a Person

Enhanced Bidirectional Text Reminders

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Bidirectional Texts

Standard Text Reminders

NO INTERVENTION

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.

Interventions

Enhanced texts with Callback by a Person 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 Text Reminders with Callback by Person

Enhanced Bidirectional Texts 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.

Enhanced Bidirectional Text Reminders

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• LADHS patient not identified as a primary care patient.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Los Angeles County Department of Public Health: collaborator

Study Sites (2)

Los Angeles County Department of Health Services

Los Angeles, California, 90012, United States

Location

University of California, Los Angeles

Los Angeles, California, 99095, United States

Location

MeSH Terms

Conditions

Influenza, Human; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Principal Investigator
• Organization: UCLA

pszilagyi@mednet.ucla.edu

310-206-6328

Study Officials

• Peter Szilagyi

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice Chair, Vice Chair for Research, UCLA David Geffen School of Medicine, Department of Pediatrics, University of California, Los Angeles

Model Details: Pragmatic comparative effectiveness trial with a standard-of-care control group

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: September 13, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 11, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-03

Locations

US (2)