InfluenzaNCT03666026
Patient Portal - Flu Reminder Recall
A study testing 1 MyChart R/R, 2 MyChart R/R and 3 MyChart R/R in people with Influenza and Respiratory Tract Infections, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 months and older
- Conditions the study is for
- Influenza, Respiratory Tract Infections, Vaccines
- What is being tested?
- 1 MyChart R/R, 2 MyChart R/R and 3 MyChart R/R
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164,205 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 2 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- A patient not identified by the UCLA Health System's internal algorithm as a primary care patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal
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).
Read the detailed description
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:
- Standard of care control (no messages)
- Up to 1 portal R/R messages
- Up to 2 portal R/R messages
- Up to 3 portal R/R messages
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.
- Conditions
- Influenza, Respiratory Tract Infections, Vaccines
- Being tested
- 1 MyChart R/R, 2 MyChart R/R, 3 MyChart R/R
- Keywords
- Reminder Recall (R/R), Influenza Vaccine, Electronic Health Record
- Medical subject headings
- Influenza, Human, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 MyChart R/RBehavioural
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.
2 MyChart R/RBehavioural
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.
3 MyChart R/RBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: 1 MyChart R/R |
| 2 MyChart R/R | Experimental | Participants in this group will receive up to 2 influenza reminder recall notices via their MyChart account Receives: Behavioral: 2 MyChart R/R |
| 3 MyChart R/R | Experimental | Participants in this group will receive up to 3 influenza reminder recall notices via their MyChart account Receives: Behavioral: 3 MyChart R/R |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: October 1, 2018 to April 2, 2019 during influenza vaccination season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start2 Oct 2018
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 164,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter G Szilagyi, MD MPH, University of California, Los Angeles
- Investigators
- Peter Szilagyi, MD MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666026
- Sponsor's protocol ID
- 17-001889
- Other IDs
- 1R01AI135029-01
- Status last verified
- Oct 2021
- First submitted
- 7 Sep 2018
- Last updated
- 17 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate results will be prepared for publication at the end of the trial.
Publications
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.
PubMed 32421168
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal
- ClinicalTrials.gov ID
- NCT03666026
- Acronym / sponsor ID
- 17-001889
- Conditions
- Influenza, Respiratory Tract Infections, Vaccines
- Keywords
- Reminder Recall (R/R), Influenza Vaccine, Electronic Health Record
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164,205 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Posted 17 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- Standard of care control (no messages)
- Up to 1 portal R/R messages
- Up to 2 portal R/R messages
- Up to 3 portal R/R messages
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of care control | No intervention | –Participants in this group will not receive any MyChart influenza vaccination reminders |
| 1 MyChart R/R | Experimental | Behavioral: 1 MyChart R/RParticipants in this group will receive up to 1 influenza reminder recall notice via their MyChart account |
| 2 MyChart R/R | Experimental | Behavioral: 2 MyChart R/RParticipants in this group will receive up to 2 influenza reminder recall notices via their MyChart account |
| 3 MyChart R/R | Experimental | Behavioral: 3 MyChart R/RParticipants in this group will receive up to 3 influenza reminder recall notices via their MyChart account |
Who may qualify
- Ages
- 4 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- A patient not identified by the UCLA Health System's internal algorithm as a primary care patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 MyChart R/RUp 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. | Behavioural | 1 MyChart R/R |
| 2 MyChart R/RUp 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. | Behavioural | 2 MyChart R/R |
| 3 MyChart R/RUp 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. | Behavioural | 3 MyChart R/R |
Primary outcome
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.
Time frame: October 1, 2018 to April 2, 2019 during influenza vaccination season
Number of participants in each arm who received influenza vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32421168Szilagyi 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.
- Individual participant dataSharing planned: No. Aggregate results will be prepared for publication at the end of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Szilagyi, MD MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 MyChart R/R, 2 MyChart R/R and 3 MyChart R/R in people with Influenza and Respiratory Tract Infections, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: October 1, 2018 to April 2, 2019 during influenza vaccination season). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.