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Synchronized Immunization NotifiCations (SINC)

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ClinicalTrials.gov Identifier: NCT02710318
Recruitment Status : Enrolling by invitation
First Posted : March 16, 2016
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

Immunization is one of the most effective public health interventions. Yet, nationally coverage has consistently fallen short of national goals, and has remained for the most part stagnant. The continued presence of vaccine-preventable diseases poses a threat to public health. In addition to needed improvement of immunization coverage for the general pediatric/adolescent population, some children with chronic medical conditions need specific additional immunizations, yet many fail to receive them.

Immunization reminders for providers in the electronic health record (EHR) are a type of clinical decision support (CDS) that can reduce missed immunization opportunities. One limitation of these reminders is that they generally depend only on data local to the EHR, which can be incomplete due to record scatter, leading to inaccurate alerts. An Immunization Information System (IIS), also known as an immunization registry, is a population-based system that collects immunization data primarily for children and adolescents from providers at a regional or state level.

The investigators seek to couple bidirectional exchange of IIS immunization information and forecasting tools with patient level medical history from the EHR to deliver accurate, patient-specific EHR immunization reminders.

Condition or disease Intervention/treatment
Vaccination Behavioral: Electronic immunization alert

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Synchronized Immunization NotifiCations
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: Immunization Alert on
Children with visits seen when the immunization alert is on
Behavioral: Electronic immunization alert
Immunization alert in the electronic health record
No Intervention: Immunization Alert off
Children with visits seen when the alert is off

Outcome Measures

Primary Outcome Measures :
  1. Under-immunization- general recommendations [ Time Frame: 1 day ]
    Percent of children and adolescents seen during the study periods who are overdue for at least one age appropriate immunization as recommended by the CDC's Advisory Committee on Immunization Practices

  2. Under-immunization- recommendations for children with chronic medical conditions [ Time Frame: 1 day ]
    Percent of children and adolescents with a chronic medical condition for which a specific additional immunization is recommended who are seen during the study periods who are overdue for at least one of these specific immunizations

  3. Over-immunization [ Time Frame: 1 day ]
    Percent of children who have received at least one immunization in excess of the recommended immunizations for their age or condition

Secondary Outcome Measures :
  1. Captured opportunity [ Time Frame: 1 day ]
    Proportion of medical visits in the analytic period during which a child/adolescent was eligible for an immunization, and received it

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • medical visit at study site during analytic period

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710318

United States, New York
Columbia University Medical Center/ NewYork Presbyterian Hospital Ambulatory Care Network
New York, New York, United States, 10032
United States, Washington
Seattle Children's Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Columbia University
New York Presbyterian Hospital
Seattle Children's Hospital
Principal Investigator: Melissa Stockwell, MD MPH Columbia University
More Information

Responsible Party: Melissa Stockwell, Associate Professor of Pediatrics and Population and Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT02710318     History of Changes
Other Study ID Numbers: AAAP6516
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs