Influenza, Respiratory Tract Infections
Conditions
Keywords
Reminder Recall (R/R), Influenza Vaccine, Electronic Health Record, Text Message, Vaccine
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).
Detailed description
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.
Interventions
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.
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.
Sponsors
Study design
Intervention model description
Pragmatic comparative effectiveness trial with a standard-of-care control group
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of the Annual Influenza Vaccine Among Pediatric Index Patients | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6,914 |
| 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. | 6,901 |
| 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. | 180,423 |
| Total | 194,238 |
Baseline characteristics
| Characteristic | Enhanced Bidirectional Text Reminders | Standard Text Reminders | Enhanced Text Reminders With Callback by Person | Total |
|---|---|---|---|---|
| Age, Customized 6 months+ | 6901 Participants | 180423 Participants | 6914 Participants | 194238 Participants |
| Primary Language English | 3588 Participants | 94207 Participants | 3656 Participants | 101451 Participants |
| Primary Language Missing | 323 Participants | 8626 Participants | 301 Participants | 9250 Participants |
| Primary Language Other | 231 Participants | 5669 Participants | 214 Participants | 6114 Participants |
| Primary Language Spanish | 2759 Participants | 71921 Participants | 2743 Participants | 77423 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 8 Participants | 216 Participants | 8 Participants | 232 Participants |
| Race/Ethnicity, Customized Asian | 383 Participants | 9773 Participants | 415 Participants | 10571 Participants |
| Race/Ethnicity, Customized Black or African American | 729 Participants | 19092 Participants | 764 Participants | 20585 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 4135 Participants | 108204 Participants | 4089 Participants | 116428 Participants |
| Race/Ethnicity, Customized Missing | 241 Participants | 6323 Participants | 220 Participants | 6784 Participants |
| Race/Ethnicity, Customized Multi-Race | 37 Participants | 1166 Participants | 45 Participants | 1248 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 9 Participants | 279 Participants | 15 Participants | 303 Participants |
| Race/Ethnicity, Customized Other/Unknown | 1061 Participants | 27213 Participants | 1066 Participants | 29340 Participants |
| Race/Ethnicity, Customized White | 298 Participants | 8157 Participants | 292 Participants | 8747 Participants |
| Sex/Gender, Customized Female | 3638 Participants | 96646 Participants | 3763 Participants | 104047 Participants |
| Sex/Gender, Customized Gender unknown | 1 Participants | 36 Participants | 3 Participants | 40 Participants |
| Sex/Gender, Customized Gender unspecified | 1 Participants | 46 Participants | 1 Participants | 48 Participants |
| Sex/Gender, Customized Male | 3020 Participants | 77372 Participants | 2927 Participants | 83319 Participants |
| Sex/Gender, Customized Missing | 241 Participants | 6323 Participants | 220 Participants | 6784 Participants |
| Vaccination in Prior Season False | 5629 Participants | 147375 Participants | 5678 Participants | 158682 Participants |
| Vaccination in Prior Season True | 1272 Participants | 33048 Participants | 1236 Participants | 35556 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Text Reminders With Callback by Person | Receipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients | 4641 Participants |
| Enhanced Bidirectional Text Reminders | Receipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients | 4629 Participants |
| Standard Text Reminders | Receipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients | 120137 Participants |
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.
Time frame: 6 months