InfluenzaNCT04533685
Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- UCLA Portal R/R Influenza RCT 3
A study testing Portal Reminders for Influenza Vaccination: Direct scheduling link, Portal Reminders for Influenza Vaccination: No direct scheduling link 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. The study design is a 2x2x2 factorial design, nested in a parallel 2-arm trial. The parallel arms are control v. 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: Direct scheduling link, Portal Reminders for Influenza Vaccination: No direct scheduling link 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
- 213,773 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Apr 2021
- 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: Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- RCT 3
This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System.
The study design is a 2x2x2 factorial design, nested in a parallel 2-arm trial. The parallel arms are control v. reminder letter (reminder messages sent via the patient portal, reminding participants of an overdue influenza vaccine)
Read more
Nested within the reminder letter arm, we will have 3 additional components:
- A direct scheduling link within the reminder letter enabling the patient to schedule an influenza vaccine only visit (direct scheduling link vs. no direct scheduling link).
- A pre-commitment prompt (pre-commitment prompt vs. no prompt) asking about a patient's intention to get the influenza vaccination
- 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)
Read the detailed description
This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System, using 2x2x2 factorial design, nested in a parallel 2-arm trial.
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) messages, 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.
This randomized controlled trial will assess the effectiveness of reminders messages, encouraging influenza vaccination, sent to patient portal users on increasing influenza vaccination rates within a health system by randomizing patients to two groups: 1) two-thirds of patients will receive reminder letters, 2) one-third will not receive reminders.
Patients in the reminder arm will be further randomized (separately) for three additional components: 1) direct appointment scheduling, 2) pre-commitment prompts and 3) pre-appointment reminders.
Direct scheduling: The convenience of scheduling an appointment for influenza vaccination may increase the likelihood that patients receive an influenza vaccination. Patients receiving reminders will be randomized to receive one of two types of reminder letters: 1) one half will receive flu vaccine reminder letters with a link to the MyChart direct appointment scheduling page and 2) one half will receive flu vaccine reminder message without the direct appointment scheduling link.
Pre-commitment: 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. Patients will be randomized to one of two groups: 1) one half will receive pre-commitment prompt at the beginning of influenza vaccination season and 2) one half will not receive a pre-commitment prompt. The pre-commitment prompt asks whether the patient intends to receive influenza vaccine, and where and when they plan to get the vaccine.
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 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).
- Conditions
- Influenza, Respiratory Tract Infections
- Being tested
- Portal Reminders for Influenza Vaccination: Direct scheduling link, Portal Reminders for Influenza Vaccination: No direct scheduling link, Pre-Commitment Prompt, Pre-Appointment flu vaccine reminders
- 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: Direct scheduling linkBehavioural
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination that include a direct scheduling link, enabling the patient to directly schedule a flu vaccination only visit
Portal Reminders for Influenza Vaccination: No direct scheduling linkBehavioural
Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)
Pre-Commitment PromptBehavioural
Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
Pre-Appointment flu vaccine remindersBehavioural
Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine
| Study group | Role | What they receive |
|---|---|---|
| Direct scheduling + Pre-commitment + Pre-appt reminder | Active comparator | Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling, 2) a pre-commitment prompt and 3) pre-appointment reminders that mention asking the provider for a flu vaccine Receives: Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link; Behavioral: Pre-Commitment Prompt; Behavioral: Pre-Appointment flu vaccine reminders |
| Direct scheduling + Pre-commitment | Active comparator | Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling and 2) a pre-commitment prompt Receives: Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link; Behavioral: Pre-Commitment Prompt |
| Direct scheduling + Pre-appt reminder | Active comparator | Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling and 2) pre-appointment reminders that mention asking the provider for a flu vaccine Receives: Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link; Behavioral: Pre-Appointment flu vaccine reminders |
| Direct scheduling | Active comparator | Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling Receives: Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link |
| No direct scheduling + Pre-commitment + Pre-Appt reminder | Active comparator | Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling, 2) a pre-commitment prompt and 3) pre-appointment reminders that mention asking the provider for a flu vaccine Receives: Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link; Behavioral: Pre-Commitment Prompt; Behavioral: Pre-Appointment flu vaccine reminders |
| No direct scheduling + Pre-commitment | Active comparator | Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling and 2) a pre-commitment prompt Receives: Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link; Behavioral: Pre-Commitment Prompt |
| No direct scheduling + Pre-appt reminder | Active comparator | Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling and 2) pre-appointment reminders that mention asking the provider for a flu vaccine Receives: Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link; Behavioral: Pre-Appointment flu vaccine reminders |
| No direct scheduling | Active comparator | Participants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling for a flu vaccine appointment Receives: Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link |
| Control Arm | No intervention | Participants will not receive any reminder/recall messages regarding influenza vaccination via the patient portal or other intervention components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Index Patients Who Received Annual Influenza Vaccine
Receipt of the annual influenza vaccination (between 8/1/20 - 4/1/21) 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 8/1/20, 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 posted31 Aug 2020
- Study start1 Sep 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
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
- Factorial
- Model description
- A 2x2x2 factorial design, nested within a parallel 2-arm trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 213,773 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, MD, MPH, Principal investigator, Professor of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533685
- Sponsor's protocol ID
- 17-001889-AM-00012
- Other IDs
- R01AI135029
- Status last verified
- Oct 2022
- First submitted
- 26 Aug 2020
- Last updated
- 25 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Szilagyi PG, Casillas A, Duru OK, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Ross MK, Friedman SR, Evans S, Sloyan M, Bogard JE, Fox CR, Lerner C. Evaluation of behavioral economic strategies to raise influenza vaccination rates across a health system: Results from a randomized clinical trial. Prev Med. 2023 May;170:107474. doi: 10.1016/j.ypmed.2023.107474. Epub 2023 Mar 2.
PubMed 36870572
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- RCT 3
- ClinicalTrials.gov ID
- NCT04533685
- Acronym / sponsor ID
- 17-001889-AM-00012
- Conditions
- Influenza, Respiratory Tract Infections
- Keywords
- Vaccination, Reminder recall, Patient Portal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213,773 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Posted 25 Oct 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.
The study design is a 2x2x2 factorial design, nested in a parallel 2-arm trial. The parallel arms are control v. reminder letter (reminder messages sent via the patient portal, reminding participants of an overdue influenza vaccine)
Nested within the reminder letter arm, we will have 3 additional components:
- A direct scheduling link within the reminder letter enabling the patient to schedule an influenza vaccine only visit (direct scheduling link vs. no direct scheduling link).
- A pre-commitment prompt (pre-commitment prompt vs. no prompt) asking about a patient's intention to get the influenza vaccination
- 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)
Detailed description
This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System, using 2x2x2 factorial design, nested in a parallel 2-arm trial.
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) messages, 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.
This randomized controlled trial will assess the effectiveness of reminders messages, encouraging influenza vaccination, sent to patient portal users on increasing influenza vaccination rates within a health system by randomizing patients to two groups: 1) two-thirds of patients will receive reminder letters, 2) one-third will not receive reminders.
Patients in the reminder arm will be further randomized (separately) for three additional components: 1) direct appointment scheduling, 2) pre-commitment prompts and 3) pre-appointment reminders.
Direct scheduling: The convenience of scheduling an appointment for influenza vaccination may increase the likelihood that patients receive an influenza vaccination. Patients receiving reminders will be randomized to receive one of two types of reminder letters: 1) one half will receive flu vaccine reminder letters with a link to the MyChart direct appointment scheduling page and 2) one half will receive flu vaccine reminder message without the direct appointment scheduling link.
Pre-commitment: 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. Patients will be randomized to one of two groups: 1) one half will receive pre-commitment prompt at the beginning of influenza vaccination season and 2) one half will not receive a pre-commitment prompt. The pre-commitment prompt asks whether the patient intends to receive influenza vaccine, and where and when they plan to get the vaccine.
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 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 9
- Model description
- A 2x2x2 factorial design, nested within a parallel 2-arm trial.
| Arm | Type | Receives |
|---|---|---|
| Direct scheduling + Pre-commitment + Pre-appt reminder | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link, Behavioral: Pre-Commitment Prompt, Behavioral: Pre-Appointment flu vaccine remindersParticipants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling, 2) a pre-commitment prompt and 3) pre-appointment reminders that mention asking the provider for a flu vaccine |
| Direct scheduling + Pre-commitment | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link, Behavioral: Pre-Commitment PromptParticipants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling and 2) a pre-commitment prompt |
| Direct scheduling + Pre-appt reminder | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling link, Behavioral: Pre-Appointment flu vaccine remindersParticipants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling and 2) pre-appointment reminders that mention asking the provider for a flu vaccine |
| Direct scheduling | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: Direct scheduling linkParticipants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal with a link enabling direct scheduling |
| No direct scheduling + Pre-commitment + Pre-Appt reminder | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link, Behavioral: Pre-Commitment Prompt, Behavioral: Pre-Appointment flu vaccine remindersParticipants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling, 2) a pre-commitment prompt and 3) pre-appointment reminders that mention asking the provider for a flu vaccine |
| No direct scheduling + Pre-commitment | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link, Behavioral: Pre-Commitment PromptParticipants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling and 2) a pre-commitment prompt |
| No direct scheduling + Pre-appt reminder | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling link, Behavioral: Pre-Appointment flu vaccine remindersParticipants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling and 2) pre-appointment reminders that mention asking the provider for a flu vaccine |
| No direct scheduling | Active comparator | Behavioral: Portal Reminders for Influenza Vaccination: No direct scheduling linkParticipants receive 1) reminder/recall messages regarding influenza vaccination via the patient portal without a link enabling direct scheduling for a flu vaccine appointment |
| Control Arm | No intervention | –Participants will not receive any reminder/recall messages regarding influenza vaccination via the patient portal or other intervention components |
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: Direct scheduling linkPatients receive reminder/recall messages via the patient portal to get an influenza vaccination that include a direct scheduling link, enabling the patient to directly schedule a flu vaccination only visit | Behavioural | Direct scheduling, Direct scheduling + Pre-appt reminder, Direct scheduling + Pre-commitment, Direct scheduling + Pre-commitment + Pre-appt reminder |
| Portal Reminders for Influenza Vaccination: No direct scheduling linkPatients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included) | Behavioural | No direct scheduling, No direct scheduling + Pre-appt reminder, No direct scheduling + Pre-commitment, No direct scheduling + Pre-commitment + Pre-Appt reminder |
| Pre-Commitment PromptPatients receive a pre-commitment prompt asking about their intention to get an influenza vaccination | Behavioural | Direct scheduling + Pre-commitment, Direct scheduling + Pre-commitment + Pre-appt reminder, No direct scheduling + Pre-commitment, No direct scheduling + Pre-commitment + Pre-Appt reminder |
| Pre-Appointment flu vaccine remindersPatients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine | Behavioural | Direct scheduling + Pre-appt reminder, Direct scheduling + Pre-commitment + Pre-appt reminder, No direct scheduling + Pre-appt reminder, No direct scheduling + Pre-commitment + Pre-Appt reminder |
Primary outcome
Number of Index Patients Who Received Annual Influenza Vaccine
Time frame: 6 months
Receipt of the annual influenza vaccination (between 8/1/20 - 4/1/21) 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 8/1/20, 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 25 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36870572Szilagyi PG, Casillas A, Duru OK, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Ross MK, Friedman SR, Evans S, Sloyan M, Bogard JE, Fox CR, Lerner C. Evaluation of behavioral economic strategies to raise influenza vaccination rates across a health system: Results from a randomized clinical trial. Prev Med. 2023 May;170:107474. doi: 10.1016/j.ypmed.2023.107474. Epub 2023 Mar 2.
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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, MD, MPH principal investigator
Professor of Pediatrics
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: Direct scheduling link, Portal Reminders for Influenza Vaccination: No direct scheduling link 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 25 Oct 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 25 Oct 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?
Number of Index Patients Who Received Annual Influenza Vaccine (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 NCT04533685, 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 25 Oct 2022.