NCT05537441

Brief Summary

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 barriers to scheduling, especially within safety net populations. The setting for this study, DHS, is the second largest public delivery system in the country and serves approximately half a million diverse patients that are eligible for vaccinations annually. This pilot study (one arm in a larger randomized controlled trial) will examine the effect of text messages highlighting MediCal health plan transportation resources (vs standard text messaging) on influenza vaccination rates in adults during the 2022-2023 flu season.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228,831

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

September 22, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 9, 2022

Results QC Date

June 1, 2024

Last Update Submit

September 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Vaccinated at the End of the Campaign Period

    Number of Participants who received their influenza vaccination during the campaign period, as measured in the California Immunization Registry (CAIR2) to include vaccinations occurring both inside and outside the LADHS system. We assessed baseline vaccination status at the beginning of the flu season and excluded individuals who already received their vaccination.

    6 months

Secondary Outcomes (1)

  • Heterogeneity of Treatment Effects for Demographics

    6 months

Study Arms (2)

Standard Texts

ACTIVE COMPARATOR

Patients randomized to this study arm will receive a standard text 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: #FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you.

Behavioral: Text messaging

Standard Texts with Transportation messaging

EXPERIMENTAL

Patients randomized to this study arm will receive standard texts plus transportation messaging including a phone number for patients to reserve transportation to a vaccination appointment based on MediCal health plan transportation resources: #FirstName#, your flu shot is ready! Call your clinic at #ExternalRefNo# or visit the LA Health Portal at http://bit.ly/BookFluShot if you want this shot held for you. You can call #Health Plan Phone Number# to schedule a free ride for your flu shot through #HealthPlanName#.

Behavioral: Text messaging

Interventions

Text messagingBEHAVIORAL

Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season.

Standard TextsStandard Texts with Transportation messaging

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Los Angeles County Department of Health Services (LACDHS) primary care patients over 6 months of age

You may not qualify if:

  • LACDHS patients less than 6 months of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles County Department of Health Services

Los Angeles, California, 90012, United States

Location

MeSH Terms

Conditions

Influenza, HumanVaccination Hesitancy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Daniella Meeker
Organization
Yale University

Study Officials

  • Daniella Meeker, PhD

    University of Southern California

    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
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 13, 2022

Study Start

September 22, 2022

Primary Completion

March 31, 2023

Study Completion

June 1, 2023

Last Updated

October 1, 2024

Results First Posted

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations