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

Head Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063087
• Other study ID #: 13-004659
• Secondary ID: FP00071515
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: January 2017

Study information

• Verified date: May 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 971
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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. GCS scores < 15

2. Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination

3. Brain tumors

4. Ventricular shunts

5. Bleeding disorder

6. Pre-existing neurological disorders complicating assessment

7. Neuroimaging at an outside hospital before transfer

8. Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication)

9. Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma

10. Known to be pregnant

11. Communication barriers such as visual or hearing impairment that may preclude use of the decision aid.

12. Strong suspicion of abuse for this head injury

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Hospitals and Clinics of MN, Minneapolis	Minneapolis	Minnesota
United States	University of Minnesota Masonic Children's Hospital	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, Davis Medical Center	Sacramento	California
United States	Children's Hospitals and Clincis of MN, St Paul ED	Saint Paul	Minnesota

Sponsors (9)

Lead Sponsor	Collaborator
Mayo Clinic	Boston Children’s Hospital, Children's Hospitals and Clinics of Minnesota, Columbia University, Flying Buttress Associates, Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute, University of California, Davis, University of Minnesota Masonic Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum in: Lancet. 2014 Jan 25;383(9914):308. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Engagement in the Decision-making Process	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.	Day 1 (during the ED visit)
Secondary	Decisional Conflict	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.	Day 1 (immediately after the clinical encounter)
Secondary	Trust in the Physician	The investigators will measure parents' trust in their clinician using the validated Trust in Physician Scale (TPS). There are 9 items with a scale of 1-5, the items are subtracted by 1, summed, divided by 9 and then multiplied by 25. The scale ranges from 0-100 where higher values are reflective of higher levels of trust in their physician.	Day 1 (immediately after the clinical encounter)
Secondary	Parental Satisfaction	The investigators will assess parents' satisfaction by comparing the number of patients who reported being "strongly satisfied" with their choice.	Day 1 (immediately after the clinical encounter)
Secondary	Proportion of Children Who Undergo Head CT	The study coordinator will ascertain whether the child underwent head CT in real time and confirm the data by health record review.	Day 1 (anytime during the index emergency department visit)
Secondary	Healthcare Utilization - Number of Tests Ordered Within 7 Days	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. Outcomes are reported as number of tests or procedures per patient, categorized based on the Berenson-Eggers Types of Service (BETOS) codes.	7-days
Secondary	Rate of Clinically Important Traumatic Brain Injury (ciTBI)	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.	7-days
Secondary	Fidelity - Options for Care	We will measure the degree to which the intervention is implemented as intended in both intervention and control groups when reviewing the recordings. The recordings in the intervention group will serve as a measure of the fidelity with which the intervention was delivered as intended. We will use a checklist of elements present and absent for quantification of implementation.	Day 1

External Links

•   Mayo Clinic Clinical Trials