Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03840798 |
| Other study ID # |
PRO18010135 |
| Secondary ID |
DI-2017C1-6215 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 26, 2019 |
| Est. completion date |
December 1, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
