NCT03840798

Brief Summary

Child maltreatment is a leading cause of death and disability in children. More than 3 million reports to Child Protective Services are made every year in the US and almost 1,600 children die annually due to maltreatment. Children who are victims of maltreatment often have significant lifelong adverse health, social, and economic consequences. Accurate and timely recognition of the early signs of child maltreatment is critical to decreasing morbidity and mortality. A significant proportion of children who suffer severe morbidity and/or mortality from maltreatment had been previously evaluated by physician(s) who did not recognize the abuse. The American Academy of Pediatrics has evidence-based recommendations for the testing which should be done as part of the medical evaluation of children with suspected physical abuse. However, despite these evidence-based recommendations, physicians fail to consistently screen for and evaluate for abuse even in high-risk situations. The investigators have developed and evaluated what the investigators believe to be the first, comprehensive electronic health record (EHR) based child abuse clinical decision support (CA-CDS). This EHR-based CA-CDS system informs medical care at multiple points during the care for a potentially maltreated child, beginning with identification of suspected abuse to the handing off of information to CPS which has a mandate to protect children who are victims of suspected maltreatment. The investigators are disseminating the following aspects of the Electronic Health Record (EHR) based child abuse- clinical decision support (CA-CDS) system which they developed as part of the investigator's initial PCORI grant.

  1. 1.a universal child abuse screen (CAS) - supports identification of maltreatment
  2. 2.an embedded child abuse alert system - supports identification of maltreatment
  3. 3.alerts to physicians and advanced practice providers - supports identification of maltreatment
  4. 4.physical abuse order set - supports proper evaluation of suspected physical abuse
  5. 5.documentation assistance for making reports of suspected maltreatment to Child Protective Services - supports mandated reporting

Trial Health

87
On Track

Trial Health Score

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

Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

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

January 7, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 26, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

January 7, 2019

Last Update Submit

January 21, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in the number of reports made to Child Protective Services (CPS)

    Number of reports to CPS made in baseline compared to go-live periods

    Up to 52 weeks for the baseline period, up to 52 weeks for the go-live period

  • Change in the compliance with American Academy of Pediatrics guidelines for evaluation of suspected abuse in patients <2 years of age

    Percent compliance with American Academy of Pediatrics guidelines for evaluation of suspected abuse in patients \<2 years of age during the baseline period compared to go-live period

    Up to 52 weeks for the baseline period, up to 52 weeks for the go-live period

Study Arms (2)

Pretest/Baseline period

Posttest/go-live period

Other: Child Abuse Clinical Decision Support system

Interventions

The investigators are implementing the following aspects of the Electronic Health Record (EHR) based child abuse- clinical decision support (CA-CDS) system. 1. a universal child abuse screen (CAS) 2. an embedded child abuse alert system 3. alerts to physicians and advanced practice providers 4. physical abuse order sets

Posttest/go-live period

Eligibility Criteria

AgeUp to 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children who present to one of the participating emergency departments during the baseline or go-live periods

You may qualify if:

  • Presenting to one of the partner hospitals AND age less than 10 years old at Wisconsin site OR age less than 13 at Northwell site

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwell Health

Manhasset, New York, 11030, United States

Location

University of Wisconsin

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Rachel Berger, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Clinical and Translational Science, Chief, Division of Child Advocacy

Study Record Dates

First Submitted

January 7, 2019

First Posted

February 15, 2019

Study Start

March 26, 2019

Primary Completion

April 15, 2020

Study Completion

December 1, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations