NCT02063087

Brief Summary

The investigators will test the impact of a decision aid, Head CT Choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to the emergency department with blunt head trauma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
971

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 9, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2.5 years

First QC Date

February 13, 2014

Results QC Date

February 7, 2017

Last Update Submit

May 8, 2019

Conditions

Head Injury

Keywords

Head CTHead InjuryPediatricEmergency DepartmentDecision AidsShared Decision Making

Outcome Measures

Primary Outcomes (1)

  • Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury

    Knowledge will be measured by means of a post visit survey delivered immediately after the clinical encounter in the emergency department. The investigators will assess parents' knowledge regarding their child's quantitative risk for a significant brain injury, the pros and cons of head CT compared to active observation, and what signs and symptoms parents should watch for in the next 24-48 hours that should prompt a return visit to the ED. Each knowledge question will provide the parent(s) with three options to respond (True, False, or Unsure), and the parent(s) will receive a score of 1 for a correct response and 0 for an incorrect response and any response of 'Unsure' will be considered incorrect. An overall score will be calculated by summing the correct responses and dividing by the number of questions asked.

    Day 1 (immediately after the clinical encounter)

Secondary Outcomes (8)

  • Patient Engagement in the Decision-making Process

    Day 1 (during the ED visit)

  • Decisional Conflict

    Day 1 (immediately after the clinical encounter)

  • Trust in the Physician

    Day 1 (immediately after the clinical encounter)

  • Parental Satisfaction

    Day 1 (immediately after the clinical encounter)

  • Proportion of Children Who Undergo Head CT

    Day 1 (anytime during the index emergency department visit)

  • +3 more secondary outcomes

Study Arms (2)

Decision Aid

ACTIVE COMPARATOR

Head CT Decision Aid

Other: Head CT Decision Aid

Usual Care

NO INTERVENTION

Clinicians and patients do not have access to the Head CT Decision Aid

Interventions

Head CT Decision AidOTHER

The decision aid, Head CT Choice, educates parents regarding how the clinician determined the severity of their child's head trauma, their child's quantitative risk for a clinically-important TBI, the pros and cons of cranial CT compared to active observation, and what signs and symptoms parents should watch for in the next 24 hours that should prompt a return visit to the ED.

Decision Aid

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Parents and their child, seeking care for a child who:
  • Is \< 18 years of age;
  • Had blunt trauma above the eyebrows (not isolated to face or eyes);
  • Is positive for at least 1 of the PECARN clinical prediction rule predictors described below:
  • PECARN Predictors for children \< 2 years of age:
  • Severe mechanism (PECARN definition)\* Loss of consciousness \> 5 seconds Acting abnormally per parent Initial ED GCS \< 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition) Presence of occipital, temporal or parietal scalp hematoma Palpable skull fracture or unclear if skull fracture
  • PECARN predictors for children 2-18 years of age:
  • Severe mechanism (PECARN definition)\* Any loss of consciousness Any vomiting since the injury Severe headache in ED Initial ED GCS \< 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition)\*\* Any sign of basilar skull fracture Clinicians include attending physicians and fellows or midlevel providers caring for children with head trauma

You may not qualify if:

  • Parents of children with:
  • GCS scores \< 15
  • Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination
  • Brain tumors
  • Ventricular shunts
  • Bleeding disorder
  • Pre-existing neurological disorders complicating assessment
  • Neuroimaging at an outside hospital before transfer
  • Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication)
  • Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma
  • Known to be pregnant
  • Communication barriers such as visual or hearing impairment that may preclude use of the decision aid.
  • Strong suspicion of abuse for this head injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospitals and Clinics of MN, Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Children's Hospitals and Clincis of MN, St Paul ED

Saint Paul, Minnesota, 55102, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (3)

  • Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14.

    PMID: 19758692BACKGROUND

  • Hess EP, Homme JL, Kharbanda AB, Tzimenatos L, Louie JP, Cohen DM, Nigrovic LE, Westphal JJ, Shah ND, Inselman J, Ferrara MJ, Herrin J, Montori VM, Kuppermann N. Effect of the Head Computed Tomography Choice Decision Aid in Parents of Children With Minor Head Trauma: A Cluster Randomized Trial. JAMA Netw Open. 2018 Sep 7;1(5):e182430. doi: 10.1001/jamanetworkopen.2018.2430.

    PMID: 30646167DERIVED

  • Hess EP, Wyatt KD, Kharbanda AB, Louie JP, Dayan PS, Tzimenatos L, Wootton-Gorges SL, Homme JL, Pencille R N L, LeBlanc A, Westphal JJ, Shepel K, Shah ND, Branda M, Herrin J, Montori VM, Kuppermann N. Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: study protocol for a multicenter randomized trial. Trials. 2014 Jun 25;15:253. doi: 10.1186/1745-6215-15-253.

    PMID: 24965659DERIVED

Related Links

MeSH Terms

Conditions

Craniocerebral TraumaEmergencies

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Erik Hess
Organization
Mayo Clinic
hess.erik@mayo.edu
507-255-6501

Study Officials

  • M.Fernanda Bellolio, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 14, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2016

Study Completion

January 1, 2017

Last Updated

May 9, 2019

Results First Posted

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(7)