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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI135029 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Los Angeles County Department of Public Health | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of the 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Szilagyi | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County Department of Health Services | Los Angeles | California | 90012 | United States | ||
| University of California, Los Angeles |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| 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, Customized | Count of Participants |
| 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 | 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. | Posted | Count of Participants | Participants | 6 months |
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We did not collect information regarding adverse events.
We did not collect adverse event information. We monitored whether reminder recall through the portal and text was effective at increased influenza vaccination rates. Because influenza vaccination is recommended by the Advisory Committee on Immunization Practices and is part of the U.S. recommended vaccine schedule, we did not collect adverse event data.
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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 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | UCLA | 310-206-6328 | pszilagyi@mednet.ucla.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 29, 2022 | Dec 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Pragmatic comparative effectiveness trial with a standard-of-care control group
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| 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. |
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| 6 months |
| Los Angeles |
| California |
| 99095 |
| United States |
| BG001 | 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. 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary Language | Count of Participants | Participants |
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| Vaccination in Prior Season | Count of Participants | Participants |
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| OG001 | 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. 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. |
| OG002 | 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. |
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|
| Secondary | Receipt of the 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 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. | Not Posted | 6 months | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012140 |
| Respiratory Tract Diseases |