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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG024968 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| University of California, Los Angeles | OTHER |
| Los Angeles County Department of Public Health | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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#. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text messaging | Behavioral | Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heterogeneity of Treatment Effects for Demographics | Heterogeneity of treatment effects for demographic groups (previous vaccination status: vaccinated or unvaccinated) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniella Meeker, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County Department of Health Services | Los Angeles | California | 90012 | United States |
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Only one household member (index person) is randomized and all other members receive the same message
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Texts | 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. Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season. |
| FG001 | Standard Texts With Transportation Messaging | 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#. Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Of the initial number randomized, only 124,793 had insurance that provided transportation benefits, and were therefore eligible for the transportation intervention and included in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Texts | 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. Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | As not all randomized participants were eligible for the transportation messaging given their insurance did not cover healthcare transportation costs, these households were removed from both groups. | Posted | Count of Participants | Participants | 6 months |
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6 months following messaging intervention
Of the initial number randomized, only 124,793 (121,743 in Standard Text, and 3050 in Standard Text + Transportation) had insurance that provided transportation benefits, and were therefore eligible for the transportation intervention and included in the baseline analysis population. Therefore, we use these numbers when determining our At Risk population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Texts | 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. Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniella Meeker | Yale University | (213)926-2658 | daniella.meeker@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2022 | May 31, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| BG001 | Standard Texts With Transportation Messaging | 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#. Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Standard Texts With Transportation Messaging | 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#. Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season. |
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|
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| Secondary | Heterogeneity of Treatment Effects for Demographics | Heterogeneity of treatment effects for demographic groups (previous vaccination status: vaccinated or unvaccinated) | As not all randomized participants were eligible for the transportation messaging given their insurance did not cover healthcare transportation costs, these households were removed from both groups. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 0 |
| 121,743 |
| 0 |
| 121,743 |
| 0 |
| 121,743 |
| EG001 | Standard Texts With Transportation Messaging | 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#. Text messaging: Patients will receive up to 3 text messages reminding them about the importance of influenza vaccination during the 2022-2023 flu season. | 0 | 3,050 | 0 | 3,050 | 0 | 3,050 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| 0.247 |
| Percent Difference |
| -0.45 |
| 2-Sided |
| Superiority |