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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI135029-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This trial is taking place in Los Angeles, CA at clinics within the UCLA Health System.
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 and cost-effectiveness of 1, 2, 3 MyChart R/R messages as compared to the standard of care control (no messages).
Annual epidemics of influenza cause substantial morbidity in the U.S. with up to 40,000 deaths/year and many hospitalizations, emergency and outpatient visits, and significant costs. Concerns about pandemic influenza elevate the need to prevent flu outbreaks.
Numerous studies, including Cochrane or systematic reviews, and reports by the CDC and the Task Force on Community Preventive Services, highlight 4 evidence-based strategies to raise child and adult influenza vaccination rates: 1) increase patient demand by reminder-recall or education, 2) expand patient access to influenza vaccinations (e.g., flu vaccine clinics), 3) implement provider strategies such as prompts or standing orders, and 4) use societal strategies (e.g., reducing costs).
Reminder/recall (R/R), sent by phone, mail or other modality, can improve child and adult influenza vaccination rates. However, fewer than one-fifth of pediatric or adult primary care practices utilize patient 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. Portals can theoretically improve upon phone, mail or text R/R by adding information such as web links, videos, or images, allowing patients to schedule their own visits, and linking to the medical chart to customize messages.
For this randomized control trial, the intent is to evaluate the impact of patient portal (MyChart) reminder recalls - either 1, 2, or 3 reminders versus the standard of care control group, specifically in relation to raising influenza vaccination rates among UCLA Health System's primary care patients aged 6 months and older.
The proposed design of this 4-arm RCT:
Hypothesis 1: >1 portal R/R will increase vaccination rates vs. no R/R. Hypothesis 2: More R/R messages will raise vaccination rates (3R/R > 2R/R > 1R/R > 0R/R).
For the primary analysis, only the data from the randomly selected index patients (1 index patient per household) will be included.
For relevant study arms, the first R/R message will be sent in October 2018.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care control | No Intervention | Participants in this group will not receive any MyChart influenza vaccination reminders | |
| 1 MyChart R/R | Experimental | Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account |
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| 2 MyChart R/R | Experimental | Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account |
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| 3 MyChart R/R | Experimental | Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 MyChart R/R | Behavioral | Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1.Receipt of the Annual Influenza Vaccine (Between 10/1/18 - 4/2/19) Among Index Patients. Outcomes Will be Assessed Via Vaccine Data Extraction From the Electronic Health Record and External Claims and Pharmacy Data. | Number of participants in each arm who received influenza vaccination | October 1, 2018 to April 2, 2019 during influenza vaccination season |
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Inclusion Criteria:
• A patient within the UCLA Health System identified by the system as a primary care patient per an internal algorithm, with a documented primary care visit within the last 3 years as of 8/1/18.
Exclusion Criteria:
• A patient not identified by the UCLA Health System's internal algorithm as a primary care patient.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Szilagyi, MD MPH | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32421168 | Derived | Szilagyi PG, Albertin C, Casillas A, Valderrama R, Duru OK, Ong MK, Vangala S, Tseng CH, Rand CM, Humiston SG, Evans S, Sloyan M, Lerner C. Effect of Patient Portal Reminders Sent by a Health Care System on Influenza Vaccination Rates: A Randomized Clinical Trial. JAMA Intern Med. 2020 Jul 1;180(7):962-970. doi: 10.1001/jamainternmed.2020.1602. |
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Aggregate results will be prepared for publication at the end of the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Control | Participants in this group will not receive any MyChart influenza vaccination reminders |
| FG001 | 1 MyChart R/R | Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account 1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
| FG002 | 2 MyChart R/R | Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account 2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
| FG003 | 3 MyChart R/R | Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account 3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients were eligible for study participation if they were at least 6 months of age at the start of intervention (ie, eligible for influenza vaccination), a primary care patient within the UCLA Health System according to the health system's criteria, and an active patient portal user (≥1 log-in during the past 12 months), other than initial account log-in.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Control | Participants in this group will not receive any MyChart influenza vaccination reminders |
| BG001 | 1 MyChart R/R | Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account 1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 1.Receipt of the Annual Influenza Vaccine (Between 10/1/18 - 4/2/19) Among Index Patients. Outcomes Will be Assessed Via Vaccine Data Extraction From the Electronic Health Record and External Claims and Pharmacy Data. | Number of participants in each arm who received influenza vaccination | Posted | Count of Participants | Participants | October 1, 2018 to April 2, 2019 during influenza vaccination season |
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This pragmatic, 4-arm randomized clinical trial was performed from October 1, 2018, to April 2, 2019, across the UCLA (University of California, Los Angeles) health care system. A total of 164 205 patients in 52 primary care practices who had used the patient portal within 12 months were included. Adverse events were not assessed/monitored.
We conducted a trial of whether reminder sent via the portal impacted influenza vaccination rates; we did not collect adverse event or serious event information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care Control | Participants in this group will not receive any MyChart influenza vaccination reminders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | UCLA | (310) 206-6328 | pszilagyi@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2017 | May 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| 2 MyChart R/R | Behavioral | Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
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| 3 MyChart R/R | Behavioral | Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
|
| BG002 | 2 MyChart R/R | Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account 2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
| BG003 | 3 MyChart R/R | Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account 3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
| BG004 | Total | Total of all reporting groups |
| Percent of participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Percent of participants |
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| Received influenza vaccination in prior two years | Number | Percent of participants |
|
| OG002 | 2 MyChart R/R | Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account 2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
| OG003 | 3 MyChart R/R | Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account 3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 1 MyChart R/R | Participants in this group will receive up to 1 influenza reminder recall notice via their MyChart account 1 MyChart R/R: Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 2 MyChart R/R | Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account 2 MyChart R/R: Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 3 MyChart R/R | Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account 3 MyChart R/R: Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012140 |
| Respiratory Tract Diseases |