NCT02710318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,348

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2018

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

March 12, 2016

Last Update Submit

September 3, 2019

Conditions

Vaccination

Keywords

ImmunizationsImmunization Information System (IIS)Immunization notifications

Outcome Measures

Primary Outcomes (3)

  • Under-immunization- general recommendations

    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

    1 day

  • Under-immunization- recommendations for children with chronic medical conditions

    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

    1 day

  • Over-immunization

    Percent of children who have received at least one immunization in excess of the recommended immunizations for their age or condition

    1 day

Secondary Outcomes (1)

  • Captured opportunity

    1 day

Study Arms (2)

Immunization Alert on

EXPERIMENTAL

Children with visits seen when the immunization alert is on

Behavioral: Electronic immunization alert

Immunization Alert off

NO INTERVENTION

Children with visits seen when the alert is off

Interventions

Electronic immunization alertBEHAVIORAL

Immunization alert in the electronic health record

Immunization Alert on

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • medical visit at study site during analytic period

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University Medical Center/ NewYork Presbyterian Hospital Ambulatory Care Network

New York, New York, 10032, United States

Location

Seattle Children's Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • Stephens AB, Wynn CS, Hofstetter AM, Kolff C, Pena O, Kahn E, Dasgupta B, Natarajan K, Vawdrey DK, Lane MM, Robbins-Milne L, Ramakrishnan R, Holleran S, Stockwell MS. Effect of Electronic Health Record Reminders for Routine Immunizations and Immunizations Needed for Chronic Medical Conditions. Appl Clin Inform. 2021 Oct;12(5):1101-1109. doi: 10.1055/s-0041-1739516. Epub 2021 Dec 15.

    PMID: 34911126DERIVED

Study Officials

  • Melissa Stockwell, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics and Population and Family Health

Study Record Dates

First Submitted

March 12, 2016

First Posted

March 16, 2016

Study Start

June 6, 2017

Primary Completion

June 5, 2018

Study Completion

June 5, 2018

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)