An interventional study of Text Fixed R/R Messages with Direct Appointment Schedule Link and Text Pre-Appointment Reminder in Influenza and Respiratory Tract Infections, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Health services research
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:
Nested within the text message reminder arm, we will have one additional component for which patients will be randomized separately:
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).
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 262,085 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Text Fixed R/R Messages with Direct Appointment Schedule Link · Behavioral: 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.
Behavioral: Text Fixed 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. 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.
Behavioral: Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link · Behavioral: Portal Pre-Appointment Reminder
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.
Behavioral: Portal Pre-Commitment Prompt with Tailored 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.
Behavioral: Portal Fixed R/R Messages with Direct Appointment Schedule Link · Behavioral: 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.
Behavioral: Portal Fixed R/R Messages with Direct Appointment Schedule Link
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.
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.
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 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.
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
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
| Milestone | Text Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | Text Fixed R/R Messages With Direct Appointment Schedule Link | Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | Portal Fixed R/R Messages With Direct Appointment Schedule Link | No R/R Message or Pre-Appointment Reminder |
|---|---|---|---|---|---|---|---|
| Started | 43682 | 43668 | 21881 | 21876 | 21864 | 21857 | 87257 |
| Completed | 43682 | 43668 | 21881 | 21876 | 21864 | 21857 | 87257 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Text Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | Text Fixed R/R Messages With Direct Appointment Schedule Link | Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | Portal Fixed R/R Messages With Direct Appointment Schedule Link | No R/R Message or Pre-Appointment Reminder |
|---|---|---|---|---|---|---|---|
| Number of Participants With Annual Influenza Vaccine Among Index Patients | 20689 | 20570 | 10374 | 10317 | 10369 | 10308 | 41166 |
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.
| Participants | Text Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | Text Fixed R/R Messages With Direct Appointment Schedule Link | Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | Portal Fixed R/R Messages With Direct Appointment Schedule Link | No R/R Message or Pre-Appointment Reminder |
|---|---|---|---|---|---|---|---|
| Number of Participants With Annual Influenza Vaccine Among Pediatric Index Patients | 2132 | 2114 | 1068 | 1082 | 1090 | 1063 | 4245 |
Collected over We did not collect information regarding adverse events.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Text Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | — | — | — |
| Text Fixed R/R Messages With Direct Appointment Schedule Link | — | — | — |
| Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | — | — | — |
| Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | — | — | — |
| Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | — | — | — |
| Portal Fixed R/R Messages With Direct Appointment Schedule Link | — | — | — |
| No R/R Message or Pre-Appointment Reminder | — | — | — |
| Age, Customized(Participants) | Text Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | Text Fixed R/R Messages With Direct Appointment Schedule Link | Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | Portal Fixed R/R Messages With Direct Appointment Schedule Link | No R/R Message or Pre-Appointment Reminder | Total |
|---|---|---|---|---|---|---|---|---|
| <18 years | 4096 | 4129 | 2065 | 2046 | 2028 | 2079 | 8238 | 24681 |
| 18-64 years | 31012 | 31106 | 15587 | 15481 | 15653 | 15514 | 62084 | 186437 |
| 65+ years | 8574 | 8433 | 4229 | 4349 | 4183 | 4264 | 16935 | 50967 |
| Sex/Gender, Customized(Participants) | Text Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | Text Fixed R/R Messages With Direct Appointment Schedule Link | Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | Portal Fixed R/R Messages With Direct Appointment Schedule Link | No R/R Message or Pre-Appointment Reminder | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 25015 | 24820 | 12491 | 12474 | 12317 | 12420 | 49812 | 149349 |
| Male | 18649 | 18827 | 9378 | 9390 | 9536 | 9430 | 37418 | 112628 |
| Other | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Unknown | 18 | 21 | 12 | 12 | 10 | 7 | 27 | 107 |
| Race/Ethnicity, Customized(Participants) | Text Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | Text Fixed R/R Messages With Direct Appointment Schedule Link | Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | Portal Fixed R/R Messages With Direct Appointment Schedule Link | No R/R Message or Pre-Appointment Reminder | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 60 | 67 | 42 | 42 | 42 | 26 | 160 | 439 |
| Asian | 2739 | 2853 | 1427 | 1390 | 1381 | 1443 | 5615 | 16848 |
| Black | 1334 | 1357 | 654 | 652 | 704 | 651 | 2728 | 8080 |
| Native Hawaiian or Other Pacific Islander | 43 | 52 | 35 | 22 | 28 | 36 | 96 | 312 |
| White or Caucasian | 14425 | 14717 | 7286 | 7350 | 7268 | 7300 | 29118 | 87464 |
| Other | 4022 | 3857 | 1970 | 1887 | 1918 | 1894 | 7817 | 23365 |
| Multiracial | 1894 | 1981 | 978 | 972 | 1018 | 1006 | 3906 | 11755 |
| Unknown | 19165 | 18784 | 9489 | 9561 | 9505 | 9501 | 37817 | 113822 |
| Race/Ethnicity, Customized(Participants) | Text Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | Text Fixed R/R Messages With Direct Appointment Schedule Link | Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | Portal Fixed R/R Messages With Direct Appointment Schedule Link | No R/R Message or Pre-Appointment Reminder | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 5316 | 5342 | 2671 | 2662 | 2680 | 2681 | 10695 | 32047 |
| Not Hispanic or Latino | 31128 | 31166 | 15597 | 15639 | 15579 | 15593 | 62246 | 186948 |
| Unknown | 7238 | 7160 | 3613 | 3575 | 3605 | 3583 | 14316 | 43090 |
| Primary Language(Participants) | Text Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | Text Fixed R/R Messages With Direct Appointment Schedule Link | Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | Portal Fixed R/R Messages With Direct Appointment Schedule Link | No R/R Message or Pre-Appointment Reminder | Total |
|---|---|---|---|---|---|---|---|---|
| English | 42617 | 42605 | 21334 | 21282 | 21330 | 21285 | 85147 | 255600 |
| Spanish | 457 | 456 | 219 | 234 | 255 | 239 | 890 | 2750 |
| Other | 549 | 543 | 306 | 329 | 261 | 300 | 1098 | 3386 |
| Unknown | 59 | 64 | 22 | 31 | 18 | 33 | 122 | 349 |
| Primary Insurance Class(Participants) | Text Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | Text Fixed R/R Messages With Direct Appointment Schedule Link | Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | Portal Fixed R/R Messages With Direct Appointment Schedule Link | No R/R Message or Pre-Appointment Reminder | Total |
|---|---|---|---|---|---|---|---|---|
| Commercial | 30710 | 30719 | 15404 | 15291 | 15539 | 15391 | 61523 | 184577 |
| Group Health Plan | 80 | 80 | 38 | 40 | 47 | 45 | 174 | 504 |
| International Payor | 7 | 11 | 6 | 9 | 3 | 6 | 26 | 68 |
| Medi-Cal | 881 | 916 | 438 | 467 | 430 | 463 | 1869 | 5464 |
| Medicare | 5366 | 5376 | 2618 | 2690 | 2529 | 2686 | 10583 | 31848 |
| Package Billing | 0 | 2 | 0 | 1 | 2 | 0 | 3 | 8 |
| Tricare | 276 | 268 | 142 | 145 | 148 | 137 | 580 | 1696 |
| UCLA Managed Care | 5756 | 5661 | 2907 | 2919 | 2865 | 2800 | 11243 | 34151 |
| Other | 542 | 580 | 291 | 288 | 267 | 292 | 1120 | 3380 |
| Unknown | 64 | 55 | 37 | 26 | 34 | 37 | 136 | 389 |
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