InfluenzaNCT04668417
Pediatric Second Influenza Dose Portal Reminder Recall
A study testing Portal Reminders for Second Dose of Influenza Vaccine with Direct Scheduling Link and Portal Reminders for Second Dose of Influenza Vaccine without Direct Scheduling Link 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 parallel 2-arm trial. The parallel arms are 1) a reminder letter for the second dose of influenza vaccine (reminder messages sent via the patient portal) with a direct… Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Influenza, Respiratory Tract Infections
- What is being tested?
- Portal Reminders for Second Dose of Influenza Vaccine with Direct Scheduling Link and Portal Reminders for Second Dose of Influenza Vaccine without Direct Scheduling Link
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 698 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient within the UCLA Health System identified as a primary care patient per an internal algorithm
- Identified as being overdue for a second dose of influenza vaccine.
Who cannot join
- Patient within the UCLA Health System not identified as a primary care patient per an internal algorithm
- Not due for a second dose of influenza vaccine.
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 the UCLA Health System- Pediatric Second Dose
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 parallel 2-arm trial. The parallel arms are 1) a reminder letter for the second dose of influenza vaccine (reminder messages sent via the patient portal) with a direct appointment scheduling link included in the reminder and 2) a reminder letter for the second dose of influenza vaccine, but no direct appointment scheduling link included.
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 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. In the U.S., 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.
Young children-especially those younger than 2- are at high risk of developing serious flu-related complications. Children ages of 6 months to 8 years getting vaccinated for the first time with influenza vaccine should get two doses, and those who have only previously gotten one dose of influenza vaccine, should get a second dose (spaced at least 4 weeks apart).
Reminder/recall (R/R) messages, sent by phone, mail or other modality, can improve child 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 increasingly used by healthcare systems.
This randomized controlled trial will assess the effectiveness of reminders messages, sent to the proxy of pediatric patients ages 6 months to <36 months of age eligible for a second dose of the influenza vaccine based on data in the EHR. Patients will be randomized into one of two arms to receive 1) a reminder letter for a second dose of influenza vaccine, with a direct appointment scheduling link included in the letter or 2) a reminder letter for a second dose of influenza vaccine, without a direct appointment scheduling link included in the letter.
- Conditions
- Influenza, Respiratory Tract Infections
- Being tested
- Portal Reminders for Second Dose of Influenza Vaccine with Direct Scheduling Link, Portal Reminders for Second Dose of Influenza Vaccine without Direct Scheduling Link
- 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 Second Dose of Influenza Vaccine with Direct Scheduling LinkBehavioural
Patient proxy receives reminder/recall messages via the patient portal to get a second dose of influenza vaccine with a direct scheduling link included, enabling the patient to directly schedule a flu vaccination only visit
Portal Reminders for Second Dose of Influenza Vaccine without Direct Scheduling LinkBehavioural
Patient proxy receives reminder/recall messages via the patient portal to get a second dose of influenza vaccine with no direct scheduling link included
| Study group | Role | What they receive |
|---|---|---|
| Reminders with direct scheduling link | Active comparator | Patient proxy receives a reminder/recall messages regarding second dose influenza vaccination via the patient portal with a link enabling direct scheduling Receives: Behavioral: Portal Reminders for Second Dose of Influenza Vaccine with Direct Scheduling Link |
| Reminders with no direct scheduling link | Active comparator | Patient proxy receives a reminder/recall messages regarding second dose influenza vaccination via the patient portal with no direct scheduling link Receives: Behavioral: Portal Reminders for Second Dose of Influenza Vaccine without Direct Scheduling Link |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who received a second dose of influenza vaccine
Receipt of a second dose of influenza vaccine (between 12/15/2020 and 4/1/21) among patients. Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data. The patient must also be an active UCLA Health MyChart user (>= 1 login over the last 12 months from 12/15/2020), excluding activity on the user's initial profile activation date. Individuals not affiliated with any primary care practice will be excluded from the analysis.
Measured: 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start15 Dec 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.
- 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
- 698 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, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668417
- Sponsor's protocol ID
- 17-001889-AM-00013
- Other IDs
- 5R01AI135029
- Status last verified
- May 2021
- First submitted
- 9 Dec 2020
- Last updated
- 28 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Portal Reminder/Recall for Influenza Vaccination in the UCLA Health System- Pediatric Second Dose
- ClinicalTrials.gov ID
- NCT04668417
- Acronym / sponsor ID
- 17-001889-AM-00013
- Conditions
- Influenza, Respiratory Tract Infections
- Keywords
- Vaccination, Reminder Recall, Patient Portal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
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 parallel 2-arm trial. The parallel arms are 1) a reminder letter for the second dose of influenza vaccine (reminder messages sent via the patient portal) with a direct appointment scheduling link included in the reminder and 2) a reminder letter for the second dose of influenza vaccine, but no direct appointment scheduling link included.
Detailed description
This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System, using 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. In the U.S., 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.
Young children-especially those younger than 2- are at high risk of developing serious flu-related complications. Children ages of 6 months to 8 years getting vaccinated for the first time with influenza vaccine should get two doses, and those who have only previously gotten one dose of influenza vaccine, should get a second dose (spaced at least 4 weeks apart).
Reminder/recall (R/R) messages, sent by phone, mail or other modality, can improve child 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 increasingly used by healthcare systems.
This randomized controlled trial will assess the effectiveness of reminders messages, sent to the proxy of pediatric patients ages 6 months to <36 months of age eligible for a second dose of the influenza vaccine based on data in the EHR. Patients will be randomized into one of two arms to receive 1) a reminder letter for a second dose of influenza vaccine, with a direct appointment scheduling link included in the letter or 2) a reminder letter for a second dose of influenza vaccine, without a direct appointment scheduling link included in the letter.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reminders with direct scheduling link | Active comparator | Behavioral: Portal Reminders for Second Dose of Influenza Vaccine with Direct Scheduling LinkPatient proxy receives a reminder/recall messages regarding second dose influenza vaccination via the patient portal with a link enabling direct scheduling |
| Reminders with no direct scheduling link | Active comparator | Behavioral: Portal Reminders for Second Dose of Influenza Vaccine without Direct Scheduling LinkPatient proxy receives a reminder/recall messages regarding second dose influenza vaccination via the patient portal with no direct scheduling link |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient within the UCLA Health System identified as a primary care patient per an internal algorithm
- Identified as being overdue for a second dose of influenza vaccine.
Key exclusion criteria (2 listed)
- Patient within the UCLA Health System not identified as a primary care patient per an internal algorithm
- Not due for a second dose of influenza vaccine.
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 Second Dose of Influenza Vaccine with Direct Scheduling LinkPatient proxy receives reminder/recall messages via the patient portal to get a second dose of influenza vaccine with a direct scheduling link included, enabling the patient to directly schedule a flu vaccination only visit | Behavioural | Reminders with direct scheduling link |
| Portal Reminders for Second Dose of Influenza Vaccine without Direct Scheduling LinkPatient proxy receives reminder/recall messages via the patient portal to get a second dose of influenza vaccine with no direct scheduling link included | Behavioural | Reminders with no direct scheduling link |
Primary outcome
Number of patients who received a second dose of influenza vaccine
Time frame: 3.5 months
Receipt of a second dose of influenza vaccine (between 12/15/2020 and 4/1/21) among patients. Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data. The patient must also be an active UCLA Health MyChart user (>= 1 login over the last 12 months from 12/15/2020), excluding activity on the user's initial profile activation date. Individuals not affiliated with any primary care practice will be excluded from the analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
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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
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 Second Dose of Influenza Vaccine with Direct Scheduling Link and Portal Reminders for Second Dose of Influenza Vaccine without Direct Scheduling Link 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 2 inclusion and 2 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 28 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 patients who received a second dose of influenza vaccine (time frame: 3.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2021.