Pediatric Abusive Head TraumaNCT03162354

The CDR Implementation Trial

A study testing Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool in people with Pediatric Abusive Head Trauma, run by Milton S. Hershey Medical Center at 8 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

Who is it for?: Ages Up to 3 years
Conditions the study is for: Pediatric Abusive Head Trauma
What is being tested?: Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 420 participants
Where: 8 sitesUnited States
Study dates: 1 Aug 2017to 31 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children under 3 years of age admitted to a PICU for management of symptomatic, acute, closed, traumatic, cranial, or intracranial injuries confirmed by computed tomography (CT) or magnetic resonance imaging (MRI).

Who cannot join

Patients admitted to a PICU with acute head injuries resulting from a collision involving a motor vehicle.
Patients admitted to a PICU with acute head injuries and clear evidence on neuroimaging of pre-existing brain malformation, disease, infection, or hypoxia-ischemia.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, 77030
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Nebraska Medical Cneter and Children's Hospital of Omaha
Omaha, Nebraska, 68114
Children's Hospital of Richmond, Virginia Commonwealth University
Richmond, Virginia, 23298
Primary Children's Hospital
Salt Lake City, Utah, 84113
University of Texas health Sciences Center at San Antonio
San Antonio, Texas, 78229
Wesley Hospital
Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: Implementation Trial of a Validated Clinical Decision Rule for Pediatric Abusive Head Trauma (NIH Grant Number P50HD089922)

To increase the accuracy of doctors' decisions to launch or forgo child abuse evaluations in their young, acutely head-injured patients, investigators have derived and validated a clinical decision rule (CDR) that detects abusive head trauma (AHT) with 96% sensitivity in pediatric intensive care unit (PICU) settings. This "CDR Implementation Trial" across eight PICU sites will assess the CDR's actual impact on AHT screening accuracy, identify factors associated with maximal physician acceptance and application of this novel AHT screening tool, and assess the sustainability of active CDR implementation strategies.

Read the detailed description

Investigators' long-term goal is to increase the accuracy of doctors' decisions to launch or forgo child abuse evaluations in their young, acutely head-injured patients. To this end, PediBIRN investigators have derived and validated a 4-variable clinical decision rule (CDR) that detects abusive head trauma (AHT) with 96% sensitivity in PICU settings. Applied at PICU admission, the CDR categorizes young, acutely head-injured patients as higher risk vs. lower risk, and recommends thorough abuse evaluations for all higher risk patients.

The "CDR Implementation Trial" across eight PICUs will assess the CDR's actual impact on AHT screening accuracy. The stratified cluster randomized trial design will facilitate direct comparison of child abuse evaluations at four, randomly selected, control sites to four matched intervention sites, where investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application. These strategies will include physician training with onsite visits, monthly "booster training emails," access to an "AHT probability calculator," audit and site-specific feedback, and local "information sharing sessions" designed to address local barriers to CDR acceptance and application.

PediBIRN investigators will conduct the CDR Implementation Trial with three Specific Aims. Aim 1 is to assess the CDR's actual impact on AHT screening accuracy. Investigators hypothesize that deployment of CDR implementation strategies at the four intervention sites will be associated with higher percentages of higher risk patients evaluated thoroughly for abuse, and lower percentages of lower risk patients evaluated (even partially) for abuse. Aim 2 is to identify factors that impact CDR application in PICU settings. Investigators hypothesize that PICUs with higher patient volumes, providers with child abuse expertise, and providers with more intense exposure to CDR implementation strategies will be predictive of higher percentages of higher risk patients thoroughly evaluated for abuse, whereas patients of minority race or ethnicity will be predictive of higher percentages of lower risk patients evaluated for abuse. Investigators' third Exploratory Aim is to measure the sustained impacts of CDR implementation strategies. Investigators hypothesize that CDR utilization at intervention sites will be sustained twelve months after CDR implementation strategies have been discontinued.

Based on strong Preliminary Studies, investigators predict that CDR adoption as an AHT screening tool will increase AHT detection; reduce overall abuse evaluations and their associated risks; reduce unwarranted variation in current AHT screening practices; minimize the adverse impacts of doctors' inherent biases, uncertainty, and practice disparities; reduce AHT-associated acute health care costs in PICU settings; and save the lives of children who will be reinjured and killed if their AHT is missed or unrecognized.

Conditions: Pediatric Abusive Head Trauma
Being tested: Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool

What participants receive

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

Application of a validated Clinical Decision Rule (CDR) as an AHT screening toolOther
The Clinical Decision Rule (CDR) for AHT reads as follows:
Every acutely head-injured infant or young child hospitalized for intensive care presenting with any one or more of these four variables should be considered "high risk" and thoroughly evaluated for abuse: (1) any clinically significant respiratory compromise at the scene of injury, during transport, in the Emergency Department, or prior to admission; (2) Any bruising involving the child's ear(s), neck, or torso; (3) Any subdural hemorrhage(s) or fluid collection(s) that are bilateral OR involve the interhemispheric space; (4) Any skull fracture(s) other than an isolated, nondiastatic, linear, parietal, skull fracture.

Study groups in NCT03162354
Study group	Role	What they receive
Intervention Sites	Experimental	At the four intervention sites, investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application as an AHT screening tool. These strategies will include physician training with onsite visits, monthly "booster training emails," access to an "AHT probability calculator," audit and site-specific feedback, and local "information sharing sessions" designed to address local barriers to CDR acceptance and application. Receives: Other: Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool
Control Sites	No intervention	At the four matched control sites, physicians will engage in "AHT screening as usual."

What is being measured

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

The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites
This outcome measure facilitates a comparison of the percentage of patients that the clinical decision rule stratified as higher risk who were evaluated thoroughly for abuse (with both skeletal survey and retinal exam) at intervention vs. control sites. We hypothesized that thorough evaluations of higher risk patients would be significantly higher at intervention sites.
Measured: To be measured 32 months after the start of the clinical trial
The Number of Lower Risk Patients Evaluated Even Partially for Abuse at Intervention vs. Control Sites
This outcome measure facilitates a comparison of the percentage of patients that the clinical decision rule stratified as lower risk who were nevertheless evaluated at least partially for abuse (with skeletal survey and/or retinal examination) at intervention vs. control sites. We hypothesized that (partial or complete) abuse evaluations of lower risk patients would be significantly lower at intervention sites.
Measured: To be measured 32 months after the start of the clinical trial
Estimated Rates (Percentages) of Missed AHT at Intervention vs. Control Sites
This outcome measures and compares estimated rates (percentages) of missed AHT (among all patients with AHT) at intervention vs. control sites. Using secondary outcome measures, it was calculated as [estimated cases of missed AHT] / [estimated cases of missed AHT + patients with corroborating findings of abuse]. We hypothesized that the estimated rate of missed AHT would be significantly lower at intervention sites. This outcome measure is best interpreted in the following contexts: (1) Applied accurately and consistently, the clinical decision rule's potential sensitivity for AHT is 96% (see references). That is, it should "miss" (categorize as lower risk) only 4% of AHT patients, and (2) We estimate that intervention and control site physicians "missed" 15% and 11% of their AHT patients, respectively, in prior PediBIRN studies (see the Post-Hoc Outcome "The Estimated Rate of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies").
Measured: To be measured 32 months after the start of the clinical trial

Secondary outcomes (5)

The Number of Patients Evaluated at Least Partially for Abuse at Intervention vs. Control Sites
This outcome measure facilitates a comparison of the percentage of patients evaluated at least partially for abuse (with skeletal survey and/or retinal examination) at intervention vs. control sites. Thus, it facilitates a broad-based comparison of AHT evaluation practices at intervention vs. control sites.
Measured: To be measured 32 months after the start of the clinical trial
The Number of Patients With Corroborating Findings of Abuse at Intervention vs. Control Sites (Aka Overall Diagnostic Yield)
This outcome measure facilitates a comparison of the percentage of patients whose completed skeletal surveys and/or retinal exams revealed findings considered moderately or highly specific for abuse at intervention vs. control sites. Thus, it is also a measure of the overall diagnostic yield of patients' completed skeletal surveys and retinal examinations.
Measured: To be measured 32 months after the start of the clinical trial
The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites
This outcome measure facilitates a comparison of the percentage of eligible patients who might be potential cases of missed AHT (that is, patients lacking skeletal survey and/or retinal exam, whose abuse evaluation is therefore incomplete) at intervention vs. control sites.
Measured: To be measured 32 months after the start of the clinical trial
The Number of Estimated Patients With Missed AHT at Intervention vs. Control Sites
This outcome measure facilitates a comparison of the estimated percentage of patients with missed AHT (among potential cases of missed AHT) at intervention vs. control sites. It was calculated as [potential cases of missed AHT] x [their mean estimate of abuse probability]. The patient-specific estimates of abuse probability used to calculate the mean estimates were accessed by applying the 4-variable rule as a clinical prediction tool (rather than a directive decision rule).
Measured: To be measured 32 months after the start of the clinical trial
Estimated Prevalence of AHT at Intervention vs. Control Sites
This outcome measure facilitates a comparison of the estimated prevalence of AHT (among all eligible patients) at intervention vs. control sites. It was calculated as [patients with corroborating findings of abuse + estimated cases of missed AHT] / [all eligible patients in each arm of the trial].
Measured: To be measured 32 months after the start of the clinical trial

Timeline

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

1 Aug 201731 Mar 2020

First posted22 May 2017
Study start1 Aug 2017
Primary completion31 Mar 2020
Study completion31 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Pediatric Abusive Head TraumaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Model description: The stratified cluster randomized trial design will facilitate direct comparison of child abuse evaluations at four, randomly selected, control sites to four matched intervention sites, where investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03162354
Sponsor's protocol ID: STUDY00005613
Other IDs: P50HD089922
Status last verified: Nov 2020
First submitted: 12 May 2017
Last updated: 16 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hymel KP, Willson DF, Boos SC, Pullin DA, Homa K, Lorenz DJ, Herman BE, Graf JM, Isaac R, Armijo-Garcia V, Narang SK; Pediatric Brain Injury Research Network (PediBIRN) Investigators. Derivation of a clinical prediction rule for pediatric abusive head trauma. Pediatr Crit Care Med. 2013 Feb;14(2):210-20. doi: 10.1097/PCC.0b013e3182712b09.
PubMed 23314183
Hymel KP, Armijo-Garcia V, Foster R, Frazier TN, Stoiko M, Christie LM, Harper NS, Weeks K, Carroll CL, Hyden P, Sirotnak A, Truemper E, Ornstein AE, Wang M; Pediatric Brain Injury Research Network (PediBIRN) Investigators. Validation of a clinical prediction rule for pediatric abusive head trauma. Pediatrics. 2014 Dec;134(6):e1537-44. doi: 10.1542/peds.2014-1329. Epub 2014 Nov 17.
PubMed 25404722
Hymel KP, Herman BE, Narang SK, Graf JM, Frazier TN, Stoiko M, Christie LM, Harper NS, Carroll CL, Boos SC, Dias M, Pullin DA, Wang M; Pediatric Brain Injury Research Network (PediBIRN) Investigators; Pediatric Brain Injury Research Network PediBIRN Investigators. Potential Impact of a Validated Screening Tool for Pediatric Abusive Head Trauma. J Pediatr. 2015 Dec;167(6):1375-81.e1. doi: 10.1016/j.jpeds.2015.09.018. Epub 2015 Oct 23.
PubMed 26477871
Hymel KP, Armijo-Garcia V, Musick M, Marinello M, Herman BE, Weeks K, Haney SB, Frazier TN, Carroll CL, Kissoon NN, Isaac R, Foster R, Campbell KA, Tieves KS, Livingston N, Bucher A, Woosley MC, Escamilla-Padilla D, Jaimon N, Kustka L, Wang M, Chinchilli VM, Dias MS, Noll J; Pediatric Brain Injury Research Network (PediBIRN) Investigators. A Cluster Randomized Trial to Reduce Missed Abusive Head Trauma in Pediatric Intensive Care Settings. J Pediatr. 2021 Sep;236:260-268.e3. doi: 10.1016/j.jpeds.2021.03.055. Epub 2021 Mar 31.
PubMed 33798512

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation Trial of a Validated Clinical Decision Rule for Pediatric Abusive Head Trauma (NIH Grant Number P50HD089922)
ClinicalTrials.gov ID: NCT03162354
Acronym / sponsor ID: STUDY00005613
Conditions: Pediatric Abusive Head Trauma
Study type: Interventional
Recruitment status: Completed
Enrolment: 420 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 1 Aug 2017 (actual)
Primary completion: 31 Mar 2020 (actual)
Study completion: 31 Mar 2020 (actual)
First posted: 22 May 2017 (actual)
Results: Posted 16 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: The stratified cluster randomized trial design will facilitate direct comparison of child abuse evaluations at four, randomly selected, control sites to four matched intervention sites, where investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application.

Arm	Type	Receives
Intervention Sites	Experimental	Other: Application of a validated Clinical Decision Rule (CDR) as an AHT screening toolAt the four intervention sites, investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application as an AHT screening tool. These strategies will include physician training with onsite visits, monthly "booster training emails," access to an "AHT probability calculator," audit and site-specific feedback, and local "information sharing sessions" designed to address local barriers to CDR acceptance and application.
Control Sites	No intervention	–At the four matched control sites, physicians will engage in "AHT screening as usual."

Who may qualify

Ages: Up to 3 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Children under 3 years of age admitted to a PICU for management of symptomatic, acute, closed, traumatic, cranial, or intracranial injuries confirmed by computed tomography (CT) or magnetic resonance imaging (MRI).

Key exclusion criteria (2 listed)

Patients admitted to a PICU with acute head injuries resulting from a collision involving a motor vehicle.
Patients admitted to a PICU with acute head injuries and clear evidence on neuroimaging of pre-existing brain malformation, disease, infection, or hypoxia-ischemia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Application of a validated Clinical Decision Rule (CDR) as an AHT screening toolThe Clinical Decision Rule (CDR) for AHT reads as follows: Every acutely head-injured infant or young child hospitalized for intensive care presenting with any one or more of these four variables should be considered "high risk" and thoroughly evaluated for abuse: (1) any clinically significant respiratory compromise at the scene of injury, during transport, in the Emergency Department, or prior to admission; (2) Any bruising involving the child's ear(s), neck, or torso; (3) Any subdural hemorrhage(s) or fluid collection(s) that are bilateral OR involve the interhemispheric space; (4) Any skull fracture(s) other than an isolated, nondiastatic, linear, parietal, skull fracture.	Other	Intervention Sites

Primary outcome

The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites
Time frame: To be measured 32 months after the start of the clinical trial
This outcome measure facilitates a comparison of the percentage of patients that the clinical decision rule stratified as higher risk who were evaluated thoroughly for abuse (with both skeletal survey and retinal exam) at intervention vs. control sites. We hypothesized that thorough evaluations of higher risk patients would be significantly higher at intervention sites.
The Number of Lower Risk Patients Evaluated Even Partially for Abuse at Intervention vs. Control Sites
Time frame: To be measured 32 months after the start of the clinical trial
This outcome measure facilitates a comparison of the percentage of patients that the clinical decision rule stratified as lower risk who were nevertheless evaluated at least partially for abuse (with skeletal survey and/or retinal examination) at intervention vs. control sites. We hypothesized that (partial or complete) abuse evaluations of lower risk patients would be significantly lower at intervention sites.
Estimated Rates (Percentages) of Missed AHT at Intervention vs. Control Sites
Time frame: To be measured 32 months after the start of the clinical trial
This outcome measures and compares estimated rates (percentages) of missed AHT (among all patients with AHT) at intervention vs. control sites. Using secondary outcome measures, it was calculated as [estimated cases of missed AHT] / [estimated cases of missed AHT + patients with corroborating findings of abuse]. We hypothesized that the estimated rate of missed AHT would be significantly lower at intervention sites. This outcome measure is best interpreted in the following contexts: (1) Applied accurately and consistently, the clinical decision rule's potential sensitivity for AHT is 96% (see references). That is, it should "miss" (categorize as lower risk) only 4% of AHT patients, and (2) We estimate that intervention and control site physicians "missed" 15% and 11% of their AHT patients, respectively, in prior PediBIRN studies (see the Post-Hoc Outcome "The Estimated Rate of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies").

5 secondary outcomes

The Number of Patients Evaluated at Least Partially for Abuse at Intervention vs. Control Sites
Time frame: To be measured 32 months after the start of the clinical trial
The Number of Patients With Corroborating Findings of Abuse at Intervention vs. Control Sites (Aka Overall Diagnostic Yield)
Time frame: To be measured 32 months after the start of the clinical trial
The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites
Time frame: To be measured 32 months after the start of the clinical trial
The Number of Estimated Patients With Missed AHT at Intervention vs. Control Sites
Time frame: To be measured 32 months after the start of the clinical trial
Estimated Prevalence of AHT at Intervention vs. Control Sites
Time frame: To be measured 32 months after the start of the clinical trial

Results and safety

Results posted to the registry on 16 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Sites	183	183
Control Sites	237	237

Primary outcome: The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites

Time frame: To be measured 32 months after the start of the clinical trial. Count of participants. Unit: Participants

Measure	Intervention Sites n = 158	Control Sites n = 175
Value	128	128

Intervention Sites vs Control Sites: Odds Ratio (OR): 0.64 (95% CI 0.37 to 1.11), p = 0.11, Chi-squared

Population analysed: From all patients in each arm of the trial that the clinical prediction rule specified to be at higher risk for abuse, this outcome measures the proportion that were evaluated "thoroughly" for abuse with skeletal survey AND retinal exam by an ophthalmologist.

Primary outcome: The Number of Lower Risk Patients Evaluated Even Partially for Abuse at Intervention vs. Control Sites

Time frame: To be measured 32 months after the start of the clinical trial. Count of participants. Unit: Participants

Measure	Intervention Sites n = 25	Control Sites n = 62
Value	17	37

Intervention Sites vs Control Sites: Odds Ratio (OR): 0.69 (95% CI 0.24 to 1.98), p = 0.49, Chi-squared

Population analysed: From all patients in each arm of the trial that the clinical prediction rule specified to be at lower risk for abuse, this outcome measures the proportion that were (nevertheless) evaluated even partially for abuse with skeletal survey and/or retinal exam by an ophthalmologist.

Primary outcome: Estimated Rates (Percentages) of Missed AHT at Intervention vs. Control Sites

Time frame: To be measured 32 months after the start of the clinical trial. Count of participants. Unit: Participants

Measure	Intervention Sites n = 81	Control Sites n = 107
Value	6	14

Intervention Sites vs Control Sites: Odds Ratio (OR): 1.88 (95% CI 0.69 to 5.13), p = 0.22, Chi-squared

Population analysed: From those patients deemed to be victims of AHT in each arm of the trial, this outcome estimates the proportion whose AHT may have been missed or unrecognized.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 32 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Sites	0 of 183 (0%)	0 of 183 (0%)	0 of 183
Control Sites	0 of 237 (0%)	0 of 237 (0%)	0 of 237

Limitations and caveats (from the sponsor): CDR implementation supports may not have been delivered uniformly. We relied on imperfect patient-specific estimates of AHT probability to predict the results of abuse evaluations never completed. We failed to capture prospective data that might explain absent or incomplete abuse evaluations (e.g., early death). The trial was likely underpowered. Our results are not generalizable to non-PICU settings, to PICUs in non-academic centers, or to PICUs lacking access to CAP physicians.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23314183Hymel KP, Willson DF, Boos SC, Pullin DA, Homa K, Lorenz DJ, Herman BE, Graf JM, Isaac R, Armijo-Garcia V, Narang SK; Pediatric Brain Injury Research Network (PediBIRN) Investigators. Derivation of a clinical prediction rule for pediatric abusive head trauma. Pediatr Crit Care Med. 2013 Feb;14(2):210-20. doi: 10.1097/PCC.0b013e3182712b09.
Background: PubMed 25404722Hymel KP, Armijo-Garcia V, Foster R, Frazier TN, Stoiko M, Christie LM, Harper NS, Weeks K, Carroll CL, Hyden P, Sirotnak A, Truemper E, Ornstein AE, Wang M; Pediatric Brain Injury Research Network (PediBIRN) Investigators. Validation of a clinical prediction rule for pediatric abusive head trauma. Pediatrics. 2014 Dec;134(6):e1537-44. doi: 10.1542/peds.2014-1329. Epub 2014 Nov 17.
Background: PubMed 26477871Hymel KP, Herman BE, Narang SK, Graf JM, Frazier TN, Stoiko M, Christie LM, Harper NS, Carroll CL, Boos SC, Dias M, Pullin DA, Wang M; Pediatric Brain Injury Research Network (PediBIRN) Investigators; Pediatric Brain Injury Research Network PediBIRN Investigators. Potential Impact of a Validated Screening Tool for Pediatric Abusive Head Trauma. J Pediatr. 2015 Dec;167(6):1375-81.e1. doi: 10.1016/j.jpeds.2015.09.018. Epub 2015 Oct 23.
Derived from this study: PubMed 33798512Hymel KP, Armijo-Garcia V, Musick M, Marinello M, Herman BE, Weeks K, Haney SB, Frazier TN, Carroll CL, Kissoon NN, Isaac R, Foster R, Campbell KA, Tieves KS, Livingston N, Bucher A, Woosley MC, Escamilla-Padilla D, Jaimon N, Kustka L, Wang M, Chinchilli VM, Dias MS, Noll J; Pediatric Brain Injury Research Network (PediBIRN) Investigators. A Cluster Randomized Trial to Reduce Missed Abusive Head Trauma in Pediatric Intensive Care Settings. J Pediatr. 2021 Sep;236:260-268.e3. doi: 10.1016/j.jpeds.2021.03.055. Epub 2021 Mar 31.
Website for "The CDR Implementation Trial"Link provided by the sponsor.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kent P. Hymel, MD principal investigator

Milton S. Hershey Medical Center

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Yes. Results are posted in the registry (first posted 16 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites (time frame: To be measured 32 months after the start of the clinical trial). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03162354, which also lists 4 linked publications.

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 16 Dec 2020.