Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mayo Clinic
Sponsor:
Collaborators:
Patient Centered Outcome Research Institute
University of California, Davis
University of Minnesota Amplatz Children's Hospital
Columbia University College of Physicians and Surgeons
Flying Buttress Associates
Children's Hospitals and Clinics of Minnesota
Information provided by (Responsible Party):
Erik P. Hess, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02063087
First received: February 13, 2014
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Head Injury
Other: Head CT Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Assess parents' knowledge regarding their child's risk for a significant brain injury [ Time Frame: Day 1 (immediately after the clinical encounter) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient engagement in the decision-making process [ Time Frame: Day 1 (during the ED visit) ] [ Designated as safety issue: No ]
    Using the OPTION validated scale, the investigators will measure the degree to which clinicians engage parents' in the decision making process. The OPTION scale will be assessed by having 2 observers independently review and score the video recordings of the encounter between the parent and the child's emergency department clinician. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48 and multiplied by 100. This creates a score that ranges from 0-100, where higher scores are reflective of a higher level of parental engagement.

  • Decisional conflict [ Time Frame: Day 1 (immediately after the clinical encounter) ] [ Designated as safety issue: No ]
    The investigators will measure the degree of conflict patients experience related to feeling uninformed using the validated Decisional Conflict Scale (DCS). The 16 items of DCS are scored on a 0-4 scale; the items are summed, divided by 16 and then multiplied by 25. The scale is from 0-100 where higher scores are reflective of parental uncertainty about the choice.

  • Trust in the physician [ Time Frame: Day 1 (immediately after the clinical encounter) ] [ Designated as safety issue: No ]
    The investigators will measure parents' trust in their clinician using the validated Trust in Physician Scale (TPS). There are 11 items with a scale of 1-5, the items are summed, divided by 11 and then multiplied by 100. The scale ranges from 0-100 where higher values are reflective of higher levels of trust in their physician.

  • Parental satisfaction [ Time Frame: Day 1 (immediately after the clinical encounter) ] [ Designated as safety issue: No ]
    The investigators will assess parents' satisfaction by asking 5 questions regarding the acceptability and satisfaction regarding the way information was shared during the encounter using a 7-point Likert scale.

  • Proportion of children who undergo head CT [ Time Frame: Day 1 (anytime during the index emergency department visit) ] [ Designated as safety issue: No ]
    The study coordinator will ascertain whether the child underwent head CT in real time and confirm the data by health record review.

  • Healthcare utilization [ Time Frame: 7-days ] [ Designated as safety issue: No ]
    The investigators will assess healthcare utilization for the subsequent 7-days after the ED visit. Healthcare utilization will include measures such as hospitalization, re-hospitalization, primary and specialty visits, and diagnostics including CT use which will be obtained via a health record review, review of itemized hospital charges on the UB-92 and UB-04 forms (summary billing statements), and parental report via the 7 day follow-up by the study coordinator.

  • Rate of clinically important traumatic brain injury (ciTBI) [ Time Frame: 7-days ] [ Designated as safety issue: Yes ]
    The investigators will assess safety by comparing the rate of ciTBI in each arm of the study. The investigators will define ciTBI as we did in the original PECARN study: death from TBI, intubation for more than 24 hours for TBI, neurosurgical procedure, or hospital admission of 2 nights or more associated with TBI on CT.


Estimated Enrollment: 1004
Study Start Date: April 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Decision Aid
Head CT Decision Aid
Other: Head CT Decision Aid
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.
No Intervention: Usual Care
Clinicians and patients do not have access to the Head CT Decision Aid

Detailed Description:

The investigators' long term goal is to promote evidence-based, patient-centered evaluation in the acute setting, to more closely tailor testing to disease risk. The investigators will compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration through the following aim:

Test if the decision aid, Head CT Choice, improves validated patient-centered outcome measures and safely decreases healthcare utilization. The investigators will randomize at the clinician level. Through the use of the intervention, Head CT Choice, the investigators aim to significantly increase parents' knowledge, engagement, and satisfaction, decrease the rate of head CT use, and decrease 7-day total healthcare utilization, with no significant increase in adverse events.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Parents and their child, seeking care for a child who:

  1. Is < 18 years of age;
  2. Had blunt trauma above the eyebrows (not isolated to face or eyes);
  3. 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

Exclusion Criteria:

Parents of children with:

  1. Palpable/unclear skull fracture or signs of basilar skull fracture on physical examination
  2. Penetrating trauma (e.g., gunshot, stab)
  3. GCS score < 14 or other signs of altered mental status (PECARN definition)
  4. > 24 hours since the injury
  5. Brain tumors
  6. Ventricular shunts
  7. Bleeding disorder
  8. Pre-existing neurological disorders complicating assessment
  9. Syncope or seizure that preceded (led to) head trauma
  10. Patient known to be pregnant
  11. Neuroimaging at an outside hospital before transfer
  12. Patient has 3 or more PECARN risk factors
  13. Parent(s) have, in their clinician's best judgment, communication barriers such as visual or hearing impairment that preclude use of the decision aid
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02063087

Contacts
Contact: Erik Hess, MD, MSc (507)284-7221 hess.erik@mayo.edu
Contact: Laurie Pencille, BA (507)538-6801 pencille.laurie@mayo.edu

Locations
United States, California
University of California, Davis Medical Center Not yet recruiting
Sacramento, California, United States, 95817
Contact: Leah Tzimenatos, MD    916-816-4542    leah.tzimenatos@ucdmc.ucdavis.edu   
Principal Investigator: Leah Tzimenatos, MD         
United States, Minnesota
Children's Hospitals and Clinics of MN, Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Anupam Karbanda, MD    651-220-6000    anupam.kharbanda@childrensmn.org   
Contact: Kristin Frenn    (612)813-7104    kristin.frenn@childrensmn.org   
Principal Investigator: Anupam Karbanda, MD         
University of Minnesota Amplatz Children's Hospital Not yet recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Jeffrey Louie, MD    612-273-4800      
Principal Investigator: Jeffrey Louie, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Erik Hess, MD, MSc    507-284-7221    hess.erik@mayo.edu   
Contact: Laurie Pencille, BA    (507)538-6801    pencille.laurie@mayo.edu   
Principal Investigator: Erik Hess, MD, MSc         
Children's Hospitals and Clincis of MN, St Paul ED Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Anupam Kabanda, MD    651-220-6000    anupam.kharbanda@childfensmn.org   
Contact: Kristin Frenn    (612)813-7104    kristin.frenn@childrensmn.org   
Principal Investigator: Anupam Karbanda, MD         
Sponsors and Collaborators
Mayo Clinic
Patient Centered Outcome Research Institute
University of California, Davis
University of Minnesota Amplatz Children's Hospital
Columbia University College of Physicians and Surgeons
Flying Buttress Associates
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: Erik Hess, MD, MSc Mayo Clinic - Rochester, MN
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erik P. Hess, Principle Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02063087     History of Changes
Other Study ID Numbers: 13-004659, FP00071515
Study First Received: February 13, 2014
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Head CT
Head Injury
Pediatric
Emergency Department
Decision Aids
Shared Decision Making

Additional relevant MeSH terms:
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014