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Patient Portal Flu Vaccine Reminders_RCT 4

Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal RCT 4

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05052190
Enrollment
239567
Registered
2021-09-22
Start date
2021-10-14
Completion date
2022-04-01
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Respiratory Tract Infections

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 UCLA Health System. The study design is a 2x2 nested factorial design. Patients will be randomized into 1) receiving text based reminder messages, 2) portal-based reminder messages or 3) the control group. Patients randomized to the intervention arms will receive reminders if they are due for influenza vaccine. Nested within the reminder arms (text or portal), we will have 2 additional components for which patients will be randomized separately: * A direct scheduling link within the reminder letter enabling the patient to schedule an influenza vaccine only visit (direct scheduling link vs. no direct scheduling link). * A pre-appointment reminder, encouraging patients to ask for their influenza vaccine at their upcoming appointment (pre-appointment reminder encouraging influenza vaccination vs. standard pre-appointment reminder not mentioning influenza vaccination) 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 MyChart R/R messages and text R/R messages as compared to the standard of care control (no messages).

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 portals-- secure, web-based communication systems, embedded within electronic health records (EHRs), for patients and providers to communicate with each other via email and the internet. Portals are used by about half of Americans and half of UCLA patients. Another is text messaging at the health system level. This randomized controlled trial will assess the effectiveness of reminders messages sent to portal users, 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 reminder letters via the portal, 2) one-third will receive reminders via text messages sent by the health system and 3) one-third will not receive reminders. Patients in the reminder arms will be further randomized (separately) for two additional components: 1) direct appointment scheduling and 2) pre-appointment reminders. Direct scheduling: The convenience of scheduling an appointment for influenza vaccination may increase the likelihood that patients receive an influenza vaccination. Patients receiving reminders will be randomized to receive one of two types of reminder letters: 1) one half will receive flu vaccine reminder letters with a link to the MyChart direct appointment scheduling page and 2) one half will receive flu vaccine reminder message without the direct appointment scheduling link. Pre-appointment flu reminders: Finally, a missed opportunities for vaccination occurs when patients are eligible for vaccination but are not offered a vaccine at their medical appointment. Pre-appointment reminders, sent in advance of an upcoming appointment, encouraging the patient talk to their doctor about influenza vaccination, may increase the likelihood of that patient receiving a vaccine. Patients will be randomized to one of two groups: 1) one half will receive modified pre-appointment reminders that mention influenza vaccination and 2) one half will receive the standard pre-appointment reminders for an upcoming appointment (no mention of influenza vaccination). Interventions that apply Behavioral Economics principles in vaccine promotion messaging can increase vaccine receipt. We will include ownership language in the pre-appointment messages. Additionally, the convenience of reminders sent via text and with a Direct Appointment Schedule link included enables patients to self-schedule a flu vaccine only visit, reducing friction for vaccine receipt. For the primary analysis, the primary outcome will be the patient's end of flu season vaccination status. Intervention effects will be assessed using mixed effects log-binomial models. Models will contain terms for messaging modality (text v. portal v. none), pre-appointment reminders (sent v. not sent), and direct scheduling link (included v. not included). The R/R text and portal messages (with and without direct scheduling links) and pre-appointment reminders and will all begin in October of 2021.

Interventions

BEHAVIORALText Message R/R with Direct Appointment Schedule Link

Participants in this arm will receive up to 3 R/R messages by text reminding them to get a flu vaccine with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

BEHAVIORALText Message R/R without Direct Appointment Schedule Link

Participants in this arm will receive up to 3 R/R messages by text reminding them to get a flu vaccine without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period advising them to get the flu vaccine at their upcoming appointment.

BEHAVIORALPortal Message R/R with Direct Appointment Schedule Link

Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

BEHAVIORALPortal Message R/R without Direct Appointment Schedule Link

Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

Participants will receive a Pre-Appointment Reminder via the portal advising them to ask their doctor for the flu vaccine at their upcoming appointment via text when they schedule a visit during the study period.

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

Pragmatic comparative effectiveness trial with a standard-of-care control group

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* Active Portal Users A patient within the UCLA Health System identified as a primary care patient per an internal algorithm

Exclusion criteria

* A patient within the UCLA Health System not identified as a primary care patient per an internal algorithm

Design outcomes

Primary

MeasureTime frameDescription
Receipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients6 monthsPercent of patients with annual influenza vaccination (between 10/1/21 - 4/1/22) 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 also be an active UCLA Health MyChart user (\>= 1 login over the last 12 months from 8/1/21, excluding activity on the user's initial profile activation date). Individuals not affiliated with any primary care practice will be excluded from the primary analysis.

Other

MeasureTime frameDescription
Receipt of the Annual Influenza Vaccine Among Pediatric Index Patients6 months - Unable to analyze data due to contaminated study armsPercent of patients with annual influenza vaccination (between 10/1/21 - 4/1/22) 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 also be an active UCLA Health MyChart user (\>= 1 login over the last 12 months from 8/1/21, excluding activity on the user's initial profile activation date). Individuals not affiliated with any primary care practice will be excluded from the primary analysis.

Countries

United States

Participant flow

Participants by arm

ArmCount
Text Message R/R With Direct Appointment Schedule Link
Participants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Text Message R/R with Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by text reminding them to get a flu vaccine with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
19,975
Text Message R/R Without Direct Appointment Schedule Link
Participants in this arm will receive up to 3 R/R messages by text with no link to schedule an appointment. Text Message R/R without Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by text reminding them to get a flu vaccine without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
19,938
Text Message R/R With Direct Appointment Schedule Link + Text Pre-Appointment Reminder
Participants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period. Text Message R/R with Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by text reminding them to get a flu vaccine with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Text Pre-Appointment Reminder: Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period advising them to get the flu vaccine at their upcoming appointment.
19,991
Text Message R/R Without Direct Appointment Schedule Link + Text Pre-Appointment Reminder
Participants in this arm will receive up to 3 R/R messages by text. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period. Text Message R/R without Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by text reminding them to get a flu vaccine without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Text Pre-Appointment Reminder: Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period advising them to get the flu vaccine at their upcoming appointment.
19,950
Portal Message R/R With Direct Appointment Schedule Link
Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Portal Message R/R with Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
20,047
Portal Message R/R Without Direct Appointment Schedule Link
Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Portal Message R/R without Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
20,008
Portal Message R/R With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder
Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period. Portal Message R/R with Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Portal Pre-Appointment Reminder: Participants will receive a Pre-Appointment Reminder via the portal advising them to ask their doctor for the flu vaccine at their upcoming appointment via text when they schedule a visit during the study period.
20,061
Portal Message R/R Without Direct Appointment Schedule Link + Portal Pre-Appointment Reminder
Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period. Portal Message R/R without Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Portal Pre-Appointment Reminder: Participants will receive a Pre-Appointment Reminder via the portal advising them to ask their doctor for the flu vaccine at their upcoming appointment via text when they schedule a visit during the study period.
20,027
No R/R Message or Pre-Appointment Reminder
Participants do not receive any flu vaccine R/R message or Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment during the specified flu season.
79,570
Total239,567

Baseline characteristics

CharacteristicText Message R/R With Direct Appointment Schedule LinkText Message R/R Without Direct Appointment Schedule LinkText Message R/R With Direct Appointment Schedule Link + Text Pre-Appointment ReminderText Message R/R Without Direct Appointment Schedule Link + Text Pre-Appointment ReminderPortal Message R/R With Direct Appointment Schedule LinkPortal Message R/R Without Direct Appointment Schedule LinkPortal Message R/R With Direct Appointment Schedule Link + Portal Pre-Appointment ReminderPortal Message R/R Without Direct Appointment Schedule Link + Portal Pre-Appointment ReminderNo R/R Message or Pre-Appointment ReminderTotal
Age, Categorical
<=18 years
1748 Participants1743 Participants1737 Participants1738 Participants1773 Participants1794 Participants1804 Participants1767 Participants7083 Participants21187 Participants
Age, Categorical
>=65 years
4005 Participants3968 Participants3958 Participants4119 Participants3975 Participants4034 Participants3994 Participants4050 Participants16019 Participants48122 Participants
Age, Categorical
Between 18 and 65 years
14222 Participants14227 Participants14296 Participants14093 Participants14299 Participants14180 Participants14263 Participants14210 Participants56468 Participants170258 Participants
Race/Ethnicity, Customized
Ethnicity
Hispanic or Latino
2179 Participants2235 Participants2247 Participants2207 Participants2269 Participants2297 Participants2325 Participants2205 Participants8866 Participants26830 Participants
Race/Ethnicity, Customized
Ethnicity
Not Hispanic or Latino
14630 Participants14575 Participants14563 Participants14628 Participants14529 Participants14538 Participants14523 Participants14638 Participants58141 Participants174765 Participants
Race/Ethnicity, Customized
Ethnicity
Unknown
3166 Participants3128 Participants3181 Participants3115 Participants3249 Participants3173 Participants3213 Participants3184 Participants12563 Participants37972 Participants
Race/Ethnicity, Customized
Race
American Indian or Alaska Native
55 Participants51 Participants60 Participants60 Participants55 Participants50 Participants42 Participants53 Participants217 Participants643 Participants
Race/Ethnicity, Customized
Race
Asian
1888 Participants1944 Participants1940 Participants1850 Participants1920 Participants1883 Participants1944 Participants1897 Participants7733 Participants22999 Participants
Race/Ethnicity, Customized
Race
Black
965 Participants941 Participants950 Participants971 Participants984 Participants976 Participants1003 Participants946 Participants3840 Participants11576 Participants
Race/Ethnicity, Customized
Race
Missing
9 Participants16 Participants14 Participants12 Participants17 Participants19 Participants14 Participants10 Participants65 Participants176 Participants
Race/Ethnicity, Customized
Race
Multiracial
565 Participants532 Participants552 Participants603 Participants620 Participants572 Participants544 Participants637 Participants2246 Participants6871 Participants
Race/Ethnicity, Customized
Race
Native Hawaiian or Other Pacific Islander
38 Participants39 Participants42 Participants32 Participants40 Participants32 Participants39 Participants42 Participants173 Participants477 Participants
Race/Ethnicity, Customized
Race
Other
2717 Participants2661 Participants2693 Participants2683 Participants2771 Participants2697 Participants2693 Participants2705 Participants10797 Participants32417 Participants
Race/Ethnicity, Customized
Race
Unknown
2988 Participants2975 Participants2986 Participants2946 Participants3060 Participants2974 Participants3064 Participants3008 Participants11817 Participants35818 Participants
Race/Ethnicity, Customized
Race
White or Caucasian
10750 Participants10779 Participants10754 Participants10793 Participants10580 Participants10805 Participants10718 Participants10729 Participants42682 Participants128590 Participants
Sex/Gender, Customized
Female
11344 Participants11251 Participants11315 Participants11352 Participants11426 Participants11301 Participants11409 Participants11405 Participants45246 Participants136049 Participants
Sex/Gender, Customized
Male
8627 Participants8683 Participants8670 Participants8597 Participants8618 Participants8707 Participants8647 Participants8620 Participants34315 Participants103484 Participants
Sex/Gender, Customized
Missing
0 Participants2 Participants4 Participants0 Participants1 Participants0 Participants3 Participants2 Participants4 Participants16 Participants
Sex/Gender, Customized
Other
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex/Gender, Customized
Unknown
4 Participants2 Participants2 Participants1 Participants2 Participants0 Participants2 Participants0 Participants5 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

Receipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients

Percent of patients with annual influenza vaccination (between 10/1/21 - 4/1/22) 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 also be an active UCLA Health MyChart user (\>= 1 login over the last 12 months from 8/1/21, excluding activity on the user's initial profile activation date). Individuals not affiliated with any primary care practice will be excluded from the primary analysis.

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Message R/R With Direct Appointment Schedule LinkReceipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients8360 Participants
Text Message R/R Without Direct Appointment Schedule LinkReceipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients8495 Participants
Text Message R/R With Direct Appointment Schedule Link + Text Pre-Appointment ReminderReceipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients8564 Participants
Text Message R/R Without Direct Appointment Schedule Link + Text Pre-Appointment ReminderReceipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients8377 Participants
Portal Message R/R With Direct Appointment Schedule LinkReceipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients8055 Participants
Portal Message R/R Without Direct Appointment Schedule LinkReceipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients7928 Participants
Portal Message R/R With Direct Appointment Schedule Link + Portal Pre-Appointment ReminderReceipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients8035 Participants
Portal Message R/R Without Direct Appointment Schedule Link + Portal Pre-Appointment ReminderReceipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients8075 Participants
No R/R Message or Pre-Appointment ReminderReceipt of the Annual Influenza Vaccine Among Adult and Pediatric Index Patients32537 Participants
Other Pre-specified

Receipt of the Annual Influenza Vaccine Among Pediatric Index Patients

Percent of patients with annual influenza vaccination (between 10/1/21 - 4/1/22) 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 also be an active UCLA Health MyChart user (\>= 1 login over the last 12 months from 8/1/21, excluding activity on the user's initial profile activation date). Individuals not affiliated with any primary care practice will be excluded from the primary analysis.

Time frame: 6 months - Unable to analyze data due to contaminated study arms

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026