Trial Outcomes & Findings for Patient Portal Flu Vaccine Reminders_RCT 5 (LADHS) (NCT NCT05535777)
NCT ID: NCT05535777
Last Updated: 2025-04-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
246295 participants
Primary outcome timeframe
6 months
Results posted on
2025-04-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6914
|
6901
|
180423
|
|
Overall Study
COMPLETED
|
6914
|
6901
|
180423
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Portal Flu Vaccine Reminders_RCT 5 (LADHS)
Baseline characteristics by cohort
| Measure |
Enhanced Text Reminders With Callback by Person
n=6914 Participants
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.
|
Enhanced Bidirectional Text Reminders
n=6901 Participants
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.
|
Standard Text Reminders
n=180423 Participants
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.
|
Total
n=194238 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
6 months+
|
6914 Participants
n=99 Participants
|
6901 Participants
n=107 Participants
|
180423 Participants
n=206 Participants
|
194238 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Female
|
3763 Participants
n=99 Participants
|
3638 Participants
n=107 Participants
|
96646 Participants
n=206 Participants
|
104047 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Male
|
2927 Participants
n=99 Participants
|
3020 Participants
n=107 Participants
|
77372 Participants
n=206 Participants
|
83319 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Gender unspecified
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Gender unknown
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Missing
|
220 Participants
n=99 Participants
|
241 Participants
n=107 Participants
|
6323 Participants
n=206 Participants
|
6784 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
216 Participants
n=206 Participants
|
232 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
415 Participants
n=99 Participants
|
383 Participants
n=107 Participants
|
9773 Participants
n=206 Participants
|
10571 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
764 Participants
n=99 Participants
|
729 Participants
n=107 Participants
|
19092 Participants
n=206 Participants
|
20585 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
4089 Participants
n=99 Participants
|
4135 Participants
n=107 Participants
|
108204 Participants
n=206 Participants
|
116428 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Multi-Race
|
45 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
1166 Participants
n=206 Participants
|
1248 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
15 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
279 Participants
n=206 Participants
|
303 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
1066 Participants
n=99 Participants
|
1061 Participants
n=107 Participants
|
27213 Participants
n=206 Participants
|
29340 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
292 Participants
n=99 Participants
|
298 Participants
n=107 Participants
|
8157 Participants
n=206 Participants
|
8747 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Missing
|
220 Participants
n=99 Participants
|
241 Participants
n=107 Participants
|
6323 Participants
n=206 Participants
|
6784 Participants
n=7 Participants
|
|
Primary Language
English
|
3656 Participants
n=99 Participants
|
3588 Participants
n=107 Participants
|
94207 Participants
n=206 Participants
|
101451 Participants
n=7 Participants
|
|
Primary Language
Spanish
|
2743 Participants
n=99 Participants
|
2759 Participants
n=107 Participants
|
71921 Participants
n=206 Participants
|
77423 Participants
n=7 Participants
|
|
Primary Language
Other
|
214 Participants
n=99 Participants
|
231 Participants
n=107 Participants
|
5669 Participants
n=206 Participants
|
6114 Participants
n=7 Participants
|
|
Primary Language
Missing
|
301 Participants
n=99 Participants
|
323 Participants
n=107 Participants
|
8626 Participants
n=206 Participants
|
9250 Participants
n=7 Participants
|
|
Vaccination in Prior Season
True
|
1236 Participants
n=99 Participants
|
1272 Participants
n=107 Participants
|
33048 Participants
n=206 Participants
|
35556 Participants
n=7 Participants
|
|
Vaccination in Prior Season
False
|
5678 Participants
n=99 Participants
|
5629 Participants
n=107 Participants
|
147375 Participants
n=206 Participants
|
158682 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercent 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.
Outcome measures
| Measure |
Enhanced Text Reminders With Callback by Person
n=6914 Participants
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.
|
Enhanced Bidirectional Text Reminders
n=6901 Participants
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.
|
Standard Text Reminders
n=180423 Participants
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.
|
|---|---|---|---|
|
Receipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients
|
4641 Participants
|
4629 Participants
|
120137 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPercent 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.
Outcome measures
Outcome data not reported
Adverse Events
Enhanced Text Reminders With Callback by Person
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Bidirectional Text Reminders
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Text Reminders
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place