- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04668417
Pediatric Second Influenza Dose Portal Reminder Recall
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 99095
- University of California LA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Reminders with direct scheduling link
Patient proxy receives a reminder/recall messages regarding second dose influenza vaccination via the patient portal with a link enabling direct scheduling
|
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
|
|
Active Comparator: Reminders with no direct scheduling link
Patient proxy receives a reminder/recall messages regarding second dose influenza vaccination via the patient portal with no direct scheduling link
|
Patient proxy receives reminder/recall messages via the patient portal to get a second dose of influenza vaccine with no direct scheduling link included
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3.5 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Peter G Szilagyi, MD, MPH, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-001889-AM-00013
- 5R01AI135029 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Portal Reminders for Second Dose of Influenza Vaccine with Direct Scheduling Link
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University of California, Los AngelesNational Institute of Allergy and Infectious Diseases (NIAID)CompletedRespiratory Tract Infections | InfluenzaUnited States