Back to resultsShared Decision Making in Parents of Children With Head Trauma: Head CT Choice
Primary Purpose
Head Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Head CT Decision Aid
Sponsored by
About this trial
This is an interventional health services research trial for Head Injury focused on measuring Head CT, Head Injury, Pediatric, Emergency Department, Decision Aids, Shared Decision Making
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- University of California, Davis Medical Center
- Boston Children's Hospital
- Children's Hospitals and Clinics of MN, Minneapolis
- University of Minnesota Masonic Children's Hospital
- Mayo Clinic
- Children's Hospitals and Clincis of MN, St Paul ED
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Decision Aid
Usual Care
Arm Description
Head CT Decision Aid
Clinicians and patients do not have access to the Head CT Decision Aid
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Parental Satisfaction
The investigators will assess parents' satisfaction by comparing the number of patients who reported being "strongly satisfied" with their choice.
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.
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.
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.
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.
Full Information
NCT ID
NCT02063087
First Posted
February 13, 2014
Last Updated
May 8, 2019
Sponsor
Mayo Clinic
Collaborators
Patient-Centered Outcomes Research Institute, University of California, Davis, University of Minnesota Masonic Children's Hospital, Columbia University, Flying Buttress Associates, Children's Hospitals and Clinics of Minnesota, Nationwide Children's Hospital, Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02063087
Brief Title
Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
Official Title
Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Patient-Centered Outcomes Research Institute, University of California, Davis, University of Minnesota Masonic Children's Hospital, Columbia University, Flying Buttress Associates, Children's Hospitals and Clinics of Minnesota, Nationwide Children's Hospital, Boston Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury
Keywords
Head CT, Head Injury, Pediatric, Emergency Department, Decision Aids, Shared Decision Making
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
971 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision Aid
Arm Type
Active Comparator
Arm Description
Head CT Decision Aid
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Clinicians and patients do not have access to the Head CT Decision Aid
Intervention Type
Other
Intervention Name(s)
Head CT Decision Aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury
Description
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.
Time Frame
Day 1 (immediately after the clinical encounter)
Secondary Outcome Measure Information:
Title
Patient Engagement in the Decision-making Process
Description
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.
Time Frame
Day 1 (during the ED visit)
Title
Decisional Conflict
Description
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.
Time Frame
Day 1 (immediately after the clinical encounter)
Title
Trust in the Physician
Description
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.
Time Frame
Day 1 (immediately after the clinical encounter)
Title
Parental Satisfaction
Description
The investigators will assess parents' satisfaction by comparing the number of patients who reported being "strongly satisfied" with their choice.
Time Frame
Day 1 (immediately after the clinical encounter)
Title
Proportion of Children Who Undergo Head CT
Description
The study coordinator will ascertain whether the child underwent head CT in real time and confirm the data by health record review.
Time Frame
Day 1 (anytime during the index emergency department visit)
Title
Healthcare Utilization - Number of Tests Ordered Within 7 Days
Description
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.
Time Frame
7-days
Title
Rate of Clinically Important Traumatic Brain Injury (ciTBI)
Description
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.
Time Frame
7-days
Title
Fidelity - Options for Care
Description
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.
Time Frame
Day 1
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M.Fernanda Bellolio, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospitals and Clinics of MN, Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota Masonic Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Children's Hospitals and Clincis of MN, St Paul ED
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19758692
Citation
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.
Results Reference
background
PubMed Identifier
30646167
Citation
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.
Results Reference
derived
PubMed Identifier
24965659
Citation
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.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
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