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Child AbuseNCT03840798

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

An observational study of Child Abuse and Physical Abuse, run by University of Pittsburgh at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 13 years
Conditions the study is for
Child Abuse, Physical Abuse, Trauma
What is being tested?
Child Abuse Clinical Decision Support system
How many people
351 participants
Where
2 sitesUnited States
Study dates
26 Mar 2019to 1 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 13 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Wisconsin

    Madison, Wisconsin, 53715

  • Northwell Health

    Manhasset, New York, 11030

Other trials in United States

About this study

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.

Read more

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.

Read the 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.

Being tested
Child Abuse Clinical Decision Support system
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Child Abuse Clinical Decision Support systemOther

    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
Study groups in NCT03840798
Study groupRoleWhat they receive
Pretest/Baseline periodNot described
Posttest/go-live periodNot described
Receives: Other: Child Abuse Clinical Decision Support system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start26 Mar 2019
  3. Primary completion15 Apr 2020
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03840798
Sponsor's protocol ID
PRO18010135
Other IDs
DI-2017C1-6215
Status last verified
Jan 2021
First submitted
7 Jan 2019
Last updated
22 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Child Abuse and Physical Abuse, run by University of Pittsburgh at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.

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