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Patient Portal Flu Vaccine Reminders (5)

Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal RCT 5

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05525494
Enrollment
262085
Registered
2022-09-01
Start date
2022-09-07
Completion date
2023-04-01
Last updated
2024-08-07

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 with direct scheduling link, 2) portal-based reminder messages with direct scheduling link, or 3) the control group. Patients randomized to the intervention arms will receive reminders if they are due for influenza vaccine. Nested within the portal reminder arm, we will have two additional components for which patients will be randomized separately: 1. A pre-commitment prompt, asking patients which time (September, October, November or December) and which place (UCLA, pharmacy, workplace or school, or other) they plan to get their Influenza vaccine with tailored monthly messages based on responses (pre-commitment message with tailored recall messages with direct scheduling vs. standard portal reminders with direct scheduling). 2. 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) Nested within the text message reminder arm, we will have one additional component for which patients will be randomized separately: 1\) 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 messages with direct scheduling and pre-appointment reminders via the portal, 2) one-third will receive reminders via text messages with direct scheduling and pre-appointment reminders sent by the health system and 3) one-third will not receive reminders. Patients in the portal-based reminder arm will be further randomized (separately) for two additional components: pre-commitment messages with tailored recall messages and pre-appointment reminders. Patients in the text message-based reminder arm will be further randomized for an additional component: pre-appointment reminders. Direct scheduling: The convenience of scheduling an appointment for influenza vaccination may increase the likelihood that patients receive an influenza vaccination. All patients receiving reminders (intervention groups) will receive flu vaccine reminder letters with a link to the MyChart direct appointment scheduling page. 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 in both the portal-based and text message-based reminder arms 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). Pre-commitment prompts with tailored monthly reminders: pre-planning the place and time of the flu vaccination may improve follow-through. A pre-commitment prompt will be sent via the portal in early September asking patients to commit to a time (September, October, November or December) and place (UCLA, pharmacy, workplace or school, or other) for their flu vaccination. Tailored monthly messages will be sent to patients based on their response to the pre-commitment prompt sent in September. Patients in the portal-based reminder arm will be randomized to one of two groups: 1) one half will receive the pre-commitment prompt and tailored monthly reminders, 2) one half will receive standard monthly reminders. Interventions that apply Behavioral Economics principles in vaccine promotion messaging can increase vaccine receipt. We will include ownership language in the pre-appointment messages. 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. Additionally, the pre-commitment prompt with tailored reminders will test the principle of implementation intention (pre-planning the place and time of the flu vaccination) has been shown in other health behavior studies to improve follow-through. 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 pre-commitment prompt (sent v. not sent). The portal-based pre-commitment prompt will be sent in September of 2022. The R/R text and portal reminder messages and pre-appointment reminders and will begin in October of 2022.

Interventions

BEHAVIORALText Fixed R/R Messages 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.

Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period.

BEHAVIORALPortal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link

Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.

BEHAVIORALPortal Fixed R/R Messages 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.

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.

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
Number of Participants With Annual Influenza Vaccine Among Index Patients6 monthsPercent of patients with annual influenza vaccination (between 9/1/22 - 4/1/23) among 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 8/1/22, 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.
Number of Participants With Annual Influenza Vaccine Among Pediatric Index Patients6 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 also be an active UCLA Health MyChart user (\>= 1 login over the last 12 months from 8/1/22, 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 Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders
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 Fixed R/R Messages 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 Pre-Appointment Reminder: Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period.
43,682
Text Fixed R/R Messages 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 Fixed R/R Messages 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.
43,668
Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders
Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). 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 Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link: Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). 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 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.
21,881
Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link
Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link: Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
21,876
Portal Fixed R/R Messages 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 Fixed R/R Messages 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 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.
21,864
Portal Fixed R/R Messages 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 Fixed R/R Messages 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.
21,857
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.
87,257
Total262,085

Baseline characteristics

CharacteristicTotalText Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment RemindersText Fixed R/R Messages With Direct Appointment Schedule LinkPortal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment RemindersPortal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule LinkPortal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment ReminderPortal Fixed R/R Messages With Direct Appointment Schedule LinkNo R/R Message or Pre-Appointment Reminder
Age, Customized
18-64 years
186437 Participants31012 Participants31106 Participants15587 Participants15481 Participants15653 Participants15514 Participants62084 Participants
Age, Customized
<18 years
24681 Participants4096 Participants4129 Participants2065 Participants2046 Participants2028 Participants2079 Participants8238 Participants
Age, Customized
65+ years
50967 Participants8574 Participants8433 Participants4229 Participants4349 Participants4183 Participants4264 Participants16935 Participants
Primary Insurance Class
Commercial
184577 Participants30710 Participants30719 Participants15404 Participants15291 Participants15539 Participants15391 Participants61523 Participants
Primary Insurance Class
Group Health Plan
504 Participants80 Participants80 Participants38 Participants40 Participants47 Participants45 Participants174 Participants
Primary Insurance Class
International Payor
68 Participants7 Participants11 Participants6 Participants9 Participants3 Participants6 Participants26 Participants
Primary Insurance Class
Medi-Cal
5464 Participants881 Participants916 Participants438 Participants467 Participants430 Participants463 Participants1869 Participants
Primary Insurance Class
Medicare
31848 Participants5366 Participants5376 Participants2618 Participants2690 Participants2529 Participants2686 Participants10583 Participants
Primary Insurance Class
Other
3380 Participants542 Participants580 Participants291 Participants288 Participants267 Participants292 Participants1120 Participants
Primary Insurance Class
Package Billing
8 Participants0 Participants2 Participants0 Participants1 Participants2 Participants0 Participants3 Participants
Primary Insurance Class
Tricare
1696 Participants276 Participants268 Participants142 Participants145 Participants148 Participants137 Participants580 Participants
Primary Insurance Class
UCLA Managed Care
34151 Participants5756 Participants5661 Participants2907 Participants2919 Participants2865 Participants2800 Participants11243 Participants
Primary Insurance Class
Unknown
389 Participants64 Participants55 Participants37 Participants26 Participants34 Participants37 Participants136 Participants
Primary Language
English
255600 Participants42617 Participants42605 Participants21334 Participants21282 Participants21330 Participants21285 Participants85147 Participants
Primary Language
Other
3386 Participants549 Participants543 Participants306 Participants329 Participants261 Participants300 Participants1098 Participants
Primary Language
Spanish
2750 Participants457 Participants456 Participants219 Participants234 Participants255 Participants239 Participants890 Participants
Primary Language
Unknown
349 Participants59 Participants64 Participants22 Participants31 Participants18 Participants33 Participants122 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
439 Participants60 Participants67 Participants42 Participants42 Participants42 Participants26 Participants160 Participants
Race/Ethnicity, Customized
Asian
16848 Participants2739 Participants2853 Participants1427 Participants1390 Participants1381 Participants1443 Participants5615 Participants
Race/Ethnicity, Customized
Black
8080 Participants1334 Participants1357 Participants654 Participants652 Participants704 Participants651 Participants2728 Participants
Race/Ethnicity, Customized
Hispanic or Latino
32047 Participants5316 Participants5342 Participants2671 Participants2662 Participants2680 Participants2681 Participants10695 Participants
Race/Ethnicity, Customized
Multiracial
11755 Participants1894 Participants1981 Participants978 Participants972 Participants1018 Participants1006 Participants3906 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
312 Participants43 Participants52 Participants35 Participants22 Participants28 Participants36 Participants96 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
186948 Participants31128 Participants31166 Participants15597 Participants15639 Participants15579 Participants15593 Participants62246 Participants
Race/Ethnicity, Customized
Other
23365 Participants4022 Participants3857 Participants1970 Participants1887 Participants1918 Participants1894 Participants7817 Participants
Race/Ethnicity, Customized
Unknown
43090 Participants19165 Participants18784 Participants9489 Participants9561 Participants9505 Participants3583 Participants37817 Participants
Race/Ethnicity, Customized
White or Caucasian
87464 Participants14425 Participants14717 Participants7286 Participants7350 Participants7268 Participants7300 Participants29118 Participants
Sex/Gender, Customized
Female
149349 Participants25015 Participants24820 Participants12491 Participants12474 Participants12317 Participants12420 Participants49812 Participants
Sex/Gender, Customized
Male
112628 Participants18649 Participants18827 Participants9378 Participants9390 Participants9536 Participants9430 Participants37418 Participants
Sex/Gender, Customized
Other
1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Sex/Gender, Customized
Unknown
107 Participants18 Participants21 Participants12 Participants12 Participants10 Participants7 Participants27 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
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

Number of Participants With Annual Influenza Vaccine Among Index Patients

Percent of patients with annual influenza vaccination (between 9/1/22 - 4/1/23) among 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 8/1/22, 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 Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment RemindersNumber of Participants With Annual Influenza Vaccine Among Index Patients20689 Participants
Text Fixed R/R Messages With Direct Appointment Schedule LinkNumber of Participants With Annual Influenza Vaccine Among Index Patients20570 Participants
Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment RemindersNumber of Participants With Annual Influenza Vaccine Among Index Patients10374 Participants
Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule LinkNumber of Participants With Annual Influenza Vaccine Among Index Patients10317 Participants
Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment ReminderNumber of Participants With Annual Influenza Vaccine Among Index Patients10369 Participants
Portal Fixed R/R Messages With Direct Appointment Schedule LinkNumber of Participants With Annual Influenza Vaccine Among Index Patients10308 Participants
No R/R Message or Pre-Appointment ReminderNumber of Participants With Annual Influenza Vaccine Among Index Patients41166 Participants
Comparison: Comparing the risk of receiving an influenza vaccination95% CI: [0.98, 1.01]
Comparison: Comparing the risk of receiving an influenza vaccination95% CI: [0.98, 1.01]
Comparison: Comparing the risk of receiving an influenza vaccination95% CI: [1, 1.02]
Comparison: Comparing the risk of receiving an influenza vaccination95% CI: [0.99, 1.01]
Primary

Number of Participants With 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 also be an active UCLA Health MyChart user (\>= 1 login over the last 12 months from 8/1/22, 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 Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment RemindersNumber of Participants With Annual Influenza Vaccine Among Pediatric Index Patients2132 Participants
Text Fixed R/R Messages With Direct Appointment Schedule LinkNumber of Participants With Annual Influenza Vaccine Among Pediatric Index Patients2114 Participants
Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment RemindersNumber of Participants With Annual Influenza Vaccine Among Pediatric Index Patients1068 Participants
Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule LinkNumber of Participants With Annual Influenza Vaccine Among Pediatric Index Patients1082 Participants
Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment ReminderNumber of Participants With Annual Influenza Vaccine Among Pediatric Index Patients1090 Participants
Portal Fixed R/R Messages With Direct Appointment Schedule LinkNumber of Participants With Annual Influenza Vaccine Among Pediatric Index Patients1063 Participants
No R/R Message or Pre-Appointment ReminderNumber of Participants With Annual Influenza Vaccine Among Pediatric Index Patients4245 Participants

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026