<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03840798</url>
  </required_header>
  <id_info>
    <org_study_id>PRO18010135</org_study_id>
    <secondary_id>DI-2017C1-6215</secondary_id>
    <nct_id>NCT03840798</nct_id>
  </id_info>
  <brief_title>Disseminating Child Abuse Clinical Decision Support to Improve Detection, Evaluation and Reporting</brief_title>
  <official_title>Disseminating Child Abuse Clinical Decision Support to Improve Detection, Evaluation and Reporting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Child maltreatment is a leading cause of death and disability in children. More than 3&#xD;
      million reports to Child Protective Services are made every year in the US and almost 1,600&#xD;
      children die annually due to maltreatment. Children who are victims of maltreatment often&#xD;
      have significant lifelong adverse health, social, and economic consequences.&#xD;
&#xD;
      Accurate and timely recognition of the early signs of child maltreatment is critical to&#xD;
      decreasing morbidity and mortality. A significant proportion of children who suffer severe&#xD;
      morbidity and/or mortality from maltreatment had been previously evaluated by physician(s)&#xD;
      who did not recognize the abuse. The American Academy of Pediatrics has evidence-based&#xD;
      recommendations for the testing which should be done as part of the medical evaluation of&#xD;
      children with suspected physical abuse. However, despite these evidence-based&#xD;
      recommendations, physicians fail to consistently screen for and evaluate for abuse even in&#xD;
      high-risk situations.&#xD;
&#xD;
      The investigators have developed and evaluated what the investigators believe to be the&#xD;
      first, comprehensive electronic health record (EHR) based child abuse clinical decision&#xD;
      support (CA-CDS). This EHR-based CA-CDS system informs medical care at multiple points during&#xD;
      the care for a potentially maltreated child, beginning with identification of suspected abuse&#xD;
      to the handing off of information to CPS which has a mandate to protect children who are&#xD;
      victims of suspected maltreatment.&#xD;
&#xD;
      The investigators are disseminating the following aspects of the Electronic Health Record&#xD;
      (EHR) based child abuse- clinical decision support (CA-CDS) system which they developed as&#xD;
      part of the investigator's initial PCORI grant.&#xD;
&#xD;
        1. a universal child abuse screen (CAS) - supports identification of maltreatment&#xD;
&#xD;
        2. an embedded child abuse alert system - supports identification of maltreatment&#xD;
&#xD;
        3. alerts to physicians and advanced practice providers - supports identification of&#xD;
           maltreatment&#xD;
&#xD;
        4. physical abuse order set - supports proper evaluation of suspected physical abuse&#xD;
&#xD;
        5. documentation assistance for making reports of suspected maltreatment to Child&#xD;
           Protective Services - supports mandated reporting&#xD;
&#xD;
      The primary objective is to disseminate and implement CA-CDS in two different EHRs in two&#xD;
      hospital systems - Northwell Health (NY) and University of Wisconsin (WI) - and to assess&#xD;
      whether the CA-CDS improves identification, evaluation and mandated reporting of child&#xD;
      maltreatment.&#xD;
&#xD;
      Aim #1 is to compare the rates of identification of possible child abuse - defined as reports&#xD;
      to Child Protective Services - before and after integration of CA-CDS into the EHR among&#xD;
      children presenting to 5 Emergency Departments in two different health systems.&#xD;
&#xD;
      Aim #2 is to compare the rate of physician compliance with American Academy of Pediatrics&#xD;
      guidelines for evaluation of suspected physical abuse before and after integration of CA-CDS&#xD;
      into the EHR in 5 Emergency Departments in two health care systems.&#xD;
&#xD;
      Once the D&amp;I is complete, the investigators will have demonstrated the feasibility of&#xD;
      implementing the CA-CDS in the three EHRs which make up 85% of all the US EHRs. This is a&#xD;
      critical step towards the goal of having a CA-CDS as a standard EHR component.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Child maltreatment is a leading cause of death and disability in children. More than 3&#xD;
      million reports to Child Protective Services are made every year in the US and almost 1,600&#xD;
      children die annually due to maltreatment. Children who are victims of maltreatment often&#xD;
      have significant lifelong adverse health, social, and economic consequences.&#xD;
&#xD;
      Accurate and timely recognition of the early signs of child maltreatment is critical to&#xD;
      decreasing morbidity and mortality. A significant proportion of children who suffer severe&#xD;
      morbidity and/or mortality from maltreatment had been previously evaluated by physician(s)&#xD;
      who did not recognize the abuse. The American Academy of Pediatrics has evidence-based&#xD;
      recommendations for the testing which should be done as part of the medical evaluation of&#xD;
      children with suspected physical abuse. However, despite these evidence-based&#xD;
      recommendations, physicians fail to consistently screen for and evaluate for abuse even in&#xD;
      high-risk situations.&#xD;
&#xD;
      The investigators have developed and evaluated what the investigators believe to be the&#xD;
      first, comprehensive electronic health record (EHR) based child abuse clinical decision&#xD;
      support (CA-CDS). This EHR-based CA-CDS system informs medical care at multiple points during&#xD;
      the care for a potentially maltreated child, beginning with identification of suspected abuse&#xD;
      to the handing off of information to CPS which has a mandate to protect children who are&#xD;
      victims of suspected maltreatment.&#xD;
&#xD;
      The investigators are disseminating the following aspects of the Electronic Health Record&#xD;
      (EHR) based child abuse- clinical decision support (CA-CDS) system which they developed as&#xD;
      part of the investigator's initial PCORI grant.&#xD;
&#xD;
        1. a universal child abuse screen (CAS) - supports identification of maltreatment&#xD;
&#xD;
        2. an embedded child abuse alert system - supports identification of maltreatment&#xD;
&#xD;
        3. alerts to physicians and advanced practice providers - supports identification of&#xD;
           maltreatment&#xD;
&#xD;
        4. physical abuse order set - supports proper evaluation of suspected physical abuse&#xD;
&#xD;
        5. documentation assistance for making reports of suspected maltreatment to Child&#xD;
           Protective Services - supports mandated reporting&#xD;
&#xD;
      The primary objective is to disseminate and implement CA-CDS in two different EHRs in two&#xD;
      hospital systems - Northwell Health (NY) and University of Wisconsin (WI) - and to assess&#xD;
      whether the CA-CDS improves identification, evaluation and mandated reporting of child&#xD;
      maltreatment.&#xD;
&#xD;
      Aim #1 is to compare the rates of identification of possible child abuse - defined as reports&#xD;
      to Child Protective Services - before and after integration of CA-CDS into the EHR among&#xD;
      children presenting to 5 Emergency Departments in two different health systems.&#xD;
&#xD;
      Aim #2 is to compare the rate of physician compliance with American Academy of Pediatrics&#xD;
      guidelines for evaluation of suspected physical abuse before and after integration of CA-CDS&#xD;
      into the EHR in 5 Emergency Departments in two health care systems.&#xD;
&#xD;
      Process metrics: Rapid cycle usability testing will be one of the earliest assessments of the&#xD;
      end-user acceptability of the CA-CDS and changes will be made to the CA-CDS based on these&#xD;
      data. Process metrics which will be measured throughout the live period, including proportion&#xD;
      of patients who receive a CAS, how often the CAS is positive, which question(s) of the CAS&#xD;
      are positive, how often any part of the CA-CDS triggers, how often order sets are used, and&#xD;
      how often providers dismiss the alert.&#xD;
&#xD;
      Short-term outcomes: Descriptive statistics will be used to describe the demographics of the&#xD;
      population. For Aim 1, the primary outcome is the report made to CPS. The proportion of&#xD;
      children who have a report made to CPS will be calculated for both the silent mode (before)&#xD;
      and live (after) groups, including race and insurance type. For Aim 2, the primary outcome is&#xD;
      compliance with the AAP guidelines for evaluation of suspected abuse in children &lt;2 yrs of&#xD;
      age. The proportion of providers who are compliant with the guidelines will be calculated for&#xD;
      both groups. Another short-term outcome will be the use of provider surveys to determine the&#xD;
      impact of the CA-CDS on clinical decision making and efficacy with identifying and evaluating&#xD;
      suspected child maltreatment. The investigators will also evaluate the impact of provider&#xD;
      training and patient racial, ethnic and socioeconomic status on these outcomes.&#xD;
&#xD;
      Long-term outcomes: A long-term outcome is whether the CA-CDS is integrated into clinical&#xD;
      practice after the end of the D&amp;I. Another long-term outcome is evaluation of the proportion&#xD;
      of cases of child maltreatment in which the child had been evaluated at least once previously&#xD;
      and the diagnosis of abuse was missed; a decrease in this proportion is a true measure of&#xD;
      improved outcome.&#xD;
&#xD;
      Once the D&amp;I is complete, the investigators will have demonstrated the feasibility of&#xD;
      implementing the CA-CDS in the three EHRs which make up 85% of all the US EHRs. This is a&#xD;
      critical step towards the goal of having a CA-CDS as a standard EHR component.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2019</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the number of reports made to Child Protective Services (CPS)</measure>
    <time_frame>Up to 52 weeks for the baseline period, up to 52 weeks for the go-live period</time_frame>
    <description>Number of reports to CPS made in baseline compared to go-live periods</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the compliance with American Academy of Pediatrics guidelines for evaluation of suspected abuse in patients &lt;2 years of age</measure>
    <time_frame>Up to 52 weeks for the baseline period, up to 52 weeks for the go-live period</time_frame>
    <description>Percent compliance with American Academy of Pediatrics guidelines for evaluation of suspected abuse in patients &lt;2 years of age during the baseline period compared to go-live period</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">351</enrollment>
  <condition>Child Abuse</condition>
  <condition>Physical Abuse</condition>
  <condition>Trauma</condition>
  <condition>Child Maltreatment</condition>
  <arm_group>
    <arm_group_label>Pretest/Baseline period</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Posttest/go-live period</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Child Abuse Clinical Decision Support system</intervention_name>
    <description>The investigators are implementing the following aspects of the Electronic Health Record (EHR) based child abuse- clinical decision support (CA-CDS) system.&#xD;
a universal child abuse screen (CAS)&#xD;
an embedded child abuse alert system&#xD;
alerts to physicians and advanced practice providers&#xD;
physical abuse order sets</description>
    <arm_group_label>Posttest/go-live period</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children who present to one of the participating emergency departments during the baseline&#xD;
        or go-live periods&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presenting to one of the partner hospitals AND age less than 10 years old at Wisconsin&#xD;
             site OR age less than 13 at Northwell site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Berger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>January 21, 2021</last_update_submitted>
  <last_update_submitted_qc>January 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Rachel Berger MD, MPH</investigator_full_name>
    <investigator_title>Professor of Pediatrics and Clinical and Translational Science, Chief, Division of Child Advocacy</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03840798
org study id: PRO18010135
secondary id: DI-2017C1-6215
nct id: NCT03840798
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Other
measure: 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
description: Number of reports to CPS made in baseline compared to go-live periods
measure: 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
description: 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
arm group label: Pretest/Baseline period
arm group label: Posttest/go-live period
intervention type: Other
intervention name: Child Abuse Clinical Decision Support system
description: 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
arm group label: Posttest/go-live period
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 13 Years
healthy volunteers: No
last name: Rachel Berger, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Rachel Berger MD, MPH
investigator title: Professor of Pediatrics and Clinical and Translational Science, Chief, Division of Child Advocacy