InfluenzaNCT04110314
Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- RCT 2
A study testing Portal Reminders for Influenza Vaccination: Gain-framed, Portal Reminders for Influenza Vaccination: Loss-framed and Pre-commitment prompt 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 among patients from primary care practices 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. Read more about this study
- Who is it for?
- Ages 4 months and older
- Conditions the study is for
- Influenza, Respiratory Tract Infections
- What is being tested?
- Portal Reminders for Influenza Vaccination: Gain-framed, Portal Reminders for Influenza Vaccination: Loss-framed and Pre-commitment prompt
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430,636 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2019to 1 Apr 2020
- 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 as a primary care patient per an internal algorithm,
Who cannot join
- A patient within the UCLA Health System not identified as a primary care patient per an internal algorithm
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California LA
Los Angeles, California, 99095
About this study
Official title: Improving Influenza Vaccination Delivery Across a Health System by the Electronic Health Records Patient Portal- RCT #2
This trial is taking place in Los Angeles, CA among patients from primary care practices 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. The investigators will assess the effectiveness of message-framing (gain-framed, loss-framed messages, no messages), as well as the effectiveness of a pre-commitment prompt (pre-commitment prompt, no prompt) asking about a patient's intention to get the influenza vaccination, using a 3 x 2 factorial design.
Read the 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 to 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.
There has been considerable research on how best to communicate about vaccines with families. A number of studies have examined the impact of gain-framed (messages emphasizing the benefits of vaccination) versus loss-framed (messages emphasizing the risks of not getting vaccinated); however, the findings have been inconsistent across studies and by sub-population.
In addition to framing, another potential influence on the decision to vaccinate is pre-commitment. Previous studies suggest that, upon being prompted, indicating an intention to do something increases the likelihood of following through. Therefore, a pre-commitment prompt is being asked of half the participants in each arm to evaluate its impact on influenza vaccination.
The purpose of this randomized controlled trial is to evaluate the impact of gain-framed and loss-framed reminder-recall messages sent via the patient portal, pre-commitment prompts sent via the patient portal, and the interactions between the two type of messages and pre-commitment on influenza vaccination among UCLA Health System's primary care patients aged 6 months and older.
The proposed design of this randomized-controlled trial is a 3 x 2 factorial design.
Standard of care control (no reminder messages, no pre-commitment prompt) No portal messages, pre-commitment prompt Gain-framed portal messages, pre-commitment prompt Gain-framed portal messages, no pre-commitment prompt Loss-framed portal messages, pre-commitment prompt Loss-framed portal messages, no pre-commitment prompt
Hyp 1. Vaccination rates will differ by receipt of no reminders, gain-framed reminders and loss-framed reminders.
1a. Vaccination rates will be higher among patients receiving gain-framed reminders than among patients receiving no reminders.
1b. Vaccination rates will be higher among patients receiving loss-framed reminders than among patients receiving no reminders.
1c. Vaccination rates will be higher among patients receiving gain-framed reminders than among patients receiving loss-framed reminders.
Hyp 2. Vaccination rates will be higher among patients receiving a pre-commitment prompt than among patients not receiving any prompt.
For relevant study arms, the first R/R messages will be sent in October 2019.
- Conditions
- Influenza, Respiratory Tract Infections
- Being tested
- Portal Reminders for Influenza Vaccination: Gain-framed, Portal Reminders for Influenza Vaccination: Loss-framed, Pre-commitment prompt
- Keywords
- Vaccination, Reminder recall, Patient Portal
- 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.
Portal Reminders for Influenza Vaccination: Gain-framedBehavioural
Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Portal Reminders for Influenza Vaccination: Loss-framedBehavioural
Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.
Pre-commitment promptBehavioural
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
| Study group | Role | What they receive |
|---|---|---|
| Gain-framed portal reminders + Pre-commitment Prompts | Active comparator | Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season Receives: Behavioral: Portal Reminders for Influenza Vaccination: Gain-framed; Behavioral: Pre-commitment prompt |
| Gain-framed portal reminders + No pre-commitment prompt | Active comparator | Participants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season Receives: Behavioral: Portal Reminders for Influenza Vaccination: Gain-framed |
| Loss-framed portal reminders + Pre-commitment prompt | Active comparator | Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season Receives: Behavioral: Portal Reminders for Influenza Vaccination: Loss-framed; Behavioral: Pre-commitment prompt |
| Loss-framed portal reminders + No pre-commitment prompt | Active comparator | Participants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season Receives: Behavioral: Portal Reminders for Influenza Vaccination: Loss-framed |
| No portal reminder + Pre-commitment prompt | Active comparator | Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal but do receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season Receives: Behavioral: Pre-commitment prompt |
| No portal reminders + No pre-commitment prompt | No intervention | Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal and do not receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of the Annual Influenza Vaccine Among Index Patients.
Receipt of the annual influenza vaccination (between 10/2/19 - 4/1/20) among index patients. Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data.
Index patients will be randomly selected individuals within an included household, eligible for the following groups (<18, 18-64 non-diabetic, 65+ non-diabetic, and 18+ diabetic). One index patient per group may be selected from each household.
The index patients must also be an active UCLA Health MyChart user (>= 1 login over the last 12 months from 8/1/19, 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start18 Oct 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
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 (2)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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 430,636 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 G Szilagyi, MPH, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110314
- Sponsor's protocol ID
- R01AI135029
- Status last verified
- Apr 2022
- First submitted
- 27 Sep 2019
- Last updated
- 5 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Szilagyi PG, Albertin CS, Casillas A, Valderrama R, Duru OK, Ong MK, Vangala S, Tseng CH, Humiston SG, Evans S, Sloyan M, Bogard JE, Fox CR, Lerner C. Effect of Personalized Messages Sent by a Health System's Patient Portal on Influenza Vaccination Rates: a Randomized Clinical Trial. J Gen Intern Med. 2022 Feb;37(3):615-623. doi: 10.1007/s11606-021-07023-w. Epub 2021 Sep 1.
PubMed 34472020Lerner C, Albertin C, Casillas A, Duru OK, Ong MK, Vangala S, Humiston S, Evans S, Sloyan M, Fox CR, Bogard JE, Friedman S, Szilagyi PG. Patient Portal Reminders for Pediatric Influenza Vaccinations: A Randomized Clinical Trial. Pediatrics. 2021 Aug;148(2):e2020048413. doi: 10.1542/peds.2020-048413.
PubMed 34321338
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. 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- RCT #2
- ClinicalTrials.gov ID
- NCT04110314
- Acronym / sponsor ID
- R01AI135029
- Conditions
- Influenza, Respiratory Tract Infections
- Keywords
- Vaccination, Reminder recall, Patient Portal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430,636 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Posted 31 Mar 2022
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 among patients from primary care practices 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. The investigators will assess the effectiveness of message-framing (gain-framed, loss-framed messages, no messages), as well as the effectiveness of a pre-commitment prompt (pre-commitment prompt, no prompt) asking about a patient's intention to get the influenza vaccination, using a 3 x 2 factorial design.
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 to 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.
There has been considerable research on how best to communicate about vaccines with families. A number of studies have examined the impact of gain-framed (messages emphasizing the benefits of vaccination) versus loss-framed (messages emphasizing the risks of not getting vaccinated); however, the findings have been inconsistent across studies and by sub-population.
In addition to framing, another potential influence on the decision to vaccinate is pre-commitment. Previous studies suggest that, upon being prompted, indicating an intention to do something increases the likelihood of following through. Therefore, a pre-commitment prompt is being asked of half the participants in each arm to evaluate its impact on influenza vaccination.
The purpose of this randomized controlled trial is to evaluate the impact of gain-framed and loss-framed reminder-recall messages sent via the patient portal, pre-commitment prompts sent via the patient portal, and the interactions between the two type of messages and pre-commitment on influenza vaccination among UCLA Health System's primary care patients aged 6 months and older.
The proposed design of this randomized-controlled trial is a 3 x 2 factorial design.
Standard of care control (no reminder messages, no pre-commitment prompt) No portal messages, pre-commitment prompt Gain-framed portal messages, pre-commitment prompt Gain-framed portal messages, no pre-commitment prompt Loss-framed portal messages, pre-commitment prompt Loss-framed portal messages, no pre-commitment prompt
Hyp 1. Vaccination rates will differ by receipt of no reminders, gain-framed reminders and loss-framed reminders.
1a. Vaccination rates will be higher among patients receiving gain-framed reminders than among patients receiving no reminders.
1b. Vaccination rates will be higher among patients receiving loss-framed reminders than among patients receiving no reminders.
1c. Vaccination rates will be higher among patients receiving gain-framed reminders than among patients receiving loss-framed reminders.
Hyp 2. Vaccination rates will be higher among patients receiving a pre-commitment prompt than among patients not receiving any prompt.
For relevant study arms, the first R/R messages will be sent in October 2019.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Gain-framed portal reminders + Pre-commitment Prompts | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: Gain-framed, Behavioral: Pre-commitment promptParticipants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season |
| Gain-framed portal reminders + No pre-commitment prompt | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: Gain-framedParticipants receive gain-framed reminder/recall messages regarding influenza vaccination via the patient portal and no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season |
| Loss-framed portal reminders + Pre-commitment prompt | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: Loss-framed, Behavioral: Pre-commitment promptParticipants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season |
| Loss-framed portal reminders + No pre-commitment prompt | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: Loss-framedParticipants receive loss-framed reminder/recall messages regarding influenza vaccination via the patient portal and a no pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season |
| No portal reminder + Pre-commitment prompt | Active comparator | Behavioral: Pre-commitment promptParticipants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal but do receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season |
| No portal reminders + No pre-commitment prompt | No intervention | –Participants do not receive any reminder/recall messages regarding influenza vaccination via the patient portal and do not receive a pre-commitment prompt asking if they plan to receive the influenza vaccine in the upcoming season |
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 as a primary care patient per an internal algorithm,
Key exclusion criteria (1 listed)
- A patient within the UCLA Health System not identified as a primary care patient per an internal algorithm
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 |
|---|---|---|
| Portal Reminders for Influenza Vaccination: Gain-framedPatients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination. | Behavioural | Gain-framed portal reminders + No pre-commitment prompt, Gain-framed portal reminders + Pre-commitment Prompts |
| Portal Reminders for Influenza Vaccination: Loss-framedPatients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination. | Behavioural | Loss-framed portal reminders + No pre-commitment prompt, Loss-framed portal reminders + Pre-commitment prompt |
| Pre-commitment promptPatients receive a pre-commitment prompt asking about their intention to get an influenza vaccination | Behavioural | Gain-framed portal reminders + Pre-commitment Prompts, Loss-framed portal reminders + Pre-commitment prompt, No portal reminder + Pre-commitment prompt |
Primary outcome
Receipt of the Annual Influenza Vaccine Among Index Patients.
Time frame: 6 months
Receipt of the annual influenza vaccination (between 10/2/19 - 4/1/20) among index patients. Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data. Index patients will be randomly selected individuals within an included household, eligible for the following groups (<18, 18-64 non-diabetic, 65+ non-diabetic, and 18+ diabetic). One index patient per group may be selected from each household. The index patients must also be an active UCLA Health MyChart user (>= 1 login over the last 12 months from 8/1/19, 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34472020Szilagyi PG, Albertin CS, Casillas A, Valderrama R, Duru OK, Ong MK, Vangala S, Tseng CH, Humiston SG, Evans S, Sloyan M, Bogard JE, Fox CR, Lerner C. Effect of Personalized Messages Sent by a Health System's Patient Portal on Influenza Vaccination Rates: a Randomized Clinical Trial. J Gen Intern Med. 2022 Feb;37(3):615-623. doi: 10.1007/s11606-021-07023-w. Epub 2021 Sep 1.
- Derived from this study: PubMed 34321338Lerner C, Albertin C, Casillas A, Duru OK, Ong MK, Vangala S, Humiston S, Evans S, Sloyan M, Fox CR, Bogard JE, Friedman S, Szilagyi PG. Patient Portal Reminders for Pediatric Influenza Vaccinations: A Randomized Clinical Trial. Pediatrics. 2021 Aug;148(2):e2020048413. doi: 10.1542/peds.2020-048413.
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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 G Szilagyi, MPH, MD 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 Portal Reminders for Influenza Vaccination: Gain-framed, Portal Reminders for Influenza Vaccination: Loss-framed and Pre-commitment prompt 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 5 May 2022. 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 31 Mar 2022). 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?
Receipt of the Annual Influenza Vaccine Among Index Patients. (time frame: 6 months). 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 NCT04110314, which also lists 2 linked publications.
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 5 May 2022.