Disseminating Child Abuse Clinical Decision Support to Improve Detection, Evaluation and Reporting

• ClinicalTrials.gov Identifier: NCT03840798
• Recruitment Status: Completed
• First Posted: February 15, 2019
• Last Update Posted: January 22, 2021
• Sponsor: University of Pittsburgh
• Collaborators: Patient-Centered Outcomes Research Institute; University of Wisconsin, Madison; Northwell Health
• Information provided by (Responsible Party): Rachel Berger MD, MPH, University of Pittsburgh

Study Description

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

The primary objective is to disseminate and implement CA-CDS in two different EHRs in two hospital systems - Northwell Health (NY) and University of Wisconsin (WI) - and to assess whether the CA-CDS improves identification, evaluation and mandated reporting of child maltreatment.

Aim #1 is to compare the rates of identification of possible child abuse - defined as reports to Child Protective Services - before and after integration of CA-CDS into the EHR among children presenting to 5 Emergency Departments in two different health systems.

Aim #2 is to compare the rate of physician compliance with American Academy of Pediatrics guidelines for evaluation of suspected physical abuse before and after integration of CA-CDS into the EHR in 5 Emergency Departments in two health care systems.

Once the D&I is complete, the investigators will have demonstrated the feasibility of implementing the CA-CDS in the three EHRs which make up 85% of all the US EHRs. This is a critical step towards the goal of having a CA-CDS as a standard EHR component.

Condition or disease	Intervention/treatment
Child Abuse; Physical Abuse; Trauma; Child Maltreatment	Other: Child Abuse Clinical Decision Support system

Detailed Description:

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

The primary objective is to disseminate and implement CA-CDS in two different EHRs in two hospital systems - Northwell Health (NY) and University of Wisconsin (WI) - and to assess whether the CA-CDS improves identification, evaluation and mandated reporting of child maltreatment.

Aim #1 is to compare the rates of identification of possible child abuse - defined as reports to Child Protective Services - before and after integration of CA-CDS into the EHR among children presenting to 5 Emergency Departments in two different health systems.

Aim #2 is to compare the rate of physician compliance with American Academy of Pediatrics guidelines for evaluation of suspected physical abuse before and after integration of CA-CDS into the EHR in 5 Emergency Departments in two health care systems.

Process metrics: Rapid cycle usability testing will be one of the earliest assessments of the end-user acceptability of the CA-CDS and changes will be made to the CA-CDS based on these data. Process metrics which will be measured throughout the live period, including proportion of patients who receive a CAS, how often the CAS is positive, which question(s) of the CAS are positive, how often any part of the CA-CDS triggers, how often order sets are used, and how often providers dismiss the alert.

Short-term outcomes: Descriptive statistics will be used to describe the demographics of the population. For Aim 1, the primary outcome is the report made to CPS. The proportion of children who have a report made to CPS will be calculated for both the silent mode (before) and live (after) groups, including race and insurance type. For Aim 2, the primary outcome is compliance with the AAP guidelines for evaluation of suspected abuse in children <2 yrs of age. The proportion of providers who are compliant with the guidelines will be calculated for both groups. Another short-term outcome will be the use of provider surveys to determine the impact of the CA-CDS on clinical decision making and efficacy with identifying and evaluating suspected child maltreatment. The investigators will also evaluate the impact of provider training and patient racial, ethnic and socioeconomic status on these outcomes.

Long-term outcomes: A long-term outcome is whether the CA-CDS is integrated into clinical practice after the end of the D&I. Another long-term outcome is evaluation of the proportion of cases of child maltreatment in which the child had been evaluated at least once previously and the diagnosis of abuse was missed; a decrease in this proportion is a true measure of improved outcome.

Once the D&I is complete, the investigators will have demonstrated the feasibility of implementing the CA-CDS in the three EHRs which make up 85% of all the US EHRs. This is a critical step towards the goal of having a CA-CDS as a standard EHR component.

Study Design

• Study Type: Observational
• Actual Enrollment: 351 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Disseminating Child Abuse Clinical Decision Support to Improve Detection, Evaluation and Reporting
• Actual Study Start Date: March 26, 2019
• Actual Primary Completion Date: April 15, 2020
• Actual Study Completion Date: December 1, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Pretest/Baseline period
Posttest/go-live period	Other: Child Abuse Clinical Decision Support system; The investigators are implementing the following aspects of the Electronic Health Record (EHR) based child abuse- clinical decision support (CA-CDS) system.; a universal child abuse screen (CAS); an embedded child abuse alert system; alerts to physicians and advanced practice providers; physical abuse order sets

Outcome Measures

Primary Outcome Measures :

1. Change in the number of reports made to Child Protective Services (CPS) [ Time Frame: Up to 52 weeks for the baseline period, up to 52 weeks for the go-live period ]
   Number of reports to CPS made in baseline compared to go-live periods
2. Change in the compliance with American Academy of Pediatrics guidelines for evaluation of suspected abuse in patients <2 years of age [ Time Frame: Up to 52 weeks for the baseline period, up to 52 weeks for the go-live period ]
   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

Eligibility Criteria

• Ages Eligible for Study: up to 13 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Contacts and Locations

Locations

United States, New York

Northwell Health

Manhasset, New York, United States, 11030

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53715

Sponsors and Collaborators

University of Pittsburgh

Patient-Centered Outcomes Research Institute

University of Wisconsin, Madison

Northwell Health

Investigators

• Principal Investigator: Rachel Berger, MD; University of Pittsburgh

More Information

• Responsible Party: Rachel Berger MD, MPH, Professor of Pediatrics and Clinical and Translational Science, Chief, Division of Child Advocacy, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03840798
• Other Study ID Numbers: PRO18010135; DI-2017C1-6215 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) )
• First Posted: February 15, 2019
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

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