Trial Outcomes & Findings for Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice (NCT NCT02063087)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

971 participants

Primary outcome timeframe

Day 1 (immediately after the clinical encounter)

Results posted on

2019-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Decision Aid Head CT Decision Aid 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.	Usual Care Clinicians and patients do not have access to the Head CT Decision Aid
Emergency Department Intervention STARTED	493	478
Emergency Department Intervention COMPLETED	493	478
Emergency Department Intervention NOT COMPLETED	0	0
7 Day Follow-up STARTED	493	478
7 Day Follow-up COMPLETED	493	478
7 Day Follow-up NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision Aid n=493 Participants Head CT Decision Aid 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.	Usual Care n=478 Participants Clinicians and patients do not have access to the Head CT Decision Aid	Total n=971 Participants Total of all reporting groups
Age, Customized Age Group · <2 years old	123 Participants n=5 Participants	109 Participants n=7 Participants	232 Participants n=5 Participants
Age, Customized Age Group · 2 to18 years old	370 Participants n=5 Participants	369 Participants n=7 Participants	739 Participants n=5 Participants
Sex: Female, Male Female	203 Participants n=5 Participants	193 Participants n=7 Participants	396 Participants n=5 Participants
Sex: Female, Male Male	290 Participants n=5 Participants	285 Participants n=7 Participants	575 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants n=5 Participants	62 Participants n=7 Participants	116 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	439 Participants n=5 Participants	416 Participants n=7 Participants	855 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	371 Participants n=5 Participants	347 Participants n=7 Participants	718 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	61 Participants n=5 Participants	54 Participants n=7 Participants	115 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian / Pacific Islander / American Indian	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	37 Participants n=5 Participants	58 Participants n=7 Participants	95 Participants n=5 Participants
Region of Enrollment United States	493 participants n=5 Participants	478 participants n=7 Participants	971 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (immediately after the clinical encounter)

Population: Analysis limited to participants with complete data.

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.

Outcome measures

Outcome measures
Measure	Decision Aid n=467 Participants Head CT Decision Aid 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.	Usual Care n=468 Participants Clinicians and patients do not have access to the Head CT Decision Aid
Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury	6.2 Number of questions correct out of 10 Standard Deviation 2.0	5.26 Number of questions correct out of 10 Standard Deviation 2.0

SECONDARY outcome

Timeframe: Day 1 (during the ED visit)

Population: Analysis limited to patients who consented to recording and had a recording of sufficient quality to analyze

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.

Outcome measures

Outcome measures
Measure	Decision Aid n=266 Participants Head CT Decision Aid 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.	Usual Care n=244 Participants Clinicians and patients do not have access to the Head CT Decision Aid
Patient Engagement in the Decision-making Process	25 Units on a scale Standard Deviation 8.5	13.3 Units on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: Day 1 (immediately after the clinical encounter)

Population: Analysis limited to participants with complete data.

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.

Outcome measures

Outcome measures
Measure	Decision Aid n=464 Participants Head CT Decision Aid 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.	Usual Care n=464 Participants Clinicians and patients do not have access to the Head CT Decision Aid
Decisional Conflict	14.8 Units on a scale Standard Deviation 15.5	19.2 Units on a scale Standard Deviation 16.6

SECONDARY outcome

Timeframe: Day 1 (immediately after the clinical encounter)

Population: Analysis limited to patients with complete data

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.

Outcome measures

Outcome measures
Measure	Decision Aid n=477 Participants Head CT Decision Aid 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.	Usual Care n=469 Participants Clinicians and patients do not have access to the Head CT Decision Aid
Trust in the Physician	91.5 units on a scale Standard Deviation 11.9	89.3 units on a scale Standard Deviation 13.7

SECONDARY outcome

Timeframe: Day 1 (immediately after the clinical encounter)

Population: Analysis limited to participants who completed a post-encounter survey

The investigators will assess parents' satisfaction by comparing the number of patients who reported being "strongly satisfied" with their choice.

Outcome measures

Outcome measures
Measure	Decision Aid n=465 Participants Head CT Decision Aid 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.	Usual Care n=465 Participants Clinicians and patients do not have access to the Head CT Decision Aid
Parental Satisfaction	254 participants "Strongly Satisfied"	210 participants "Strongly Satisfied"

SECONDARY outcome

Timeframe: Day 1 (anytime during the index emergency department visit)

The study coordinator will ascertain whether the child underwent head CT in real time and confirm the data by health record review.

Outcome measures

Outcome measures
Measure	Decision Aid n=493 Participants Head CT Decision Aid 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.	Usual Care n=478 Participants Clinicians and patients do not have access to the Head CT Decision Aid
Proportion of Children Who Undergo Head CT	109 Participants	116 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Decision Aid n=493 Participants Head CT Decision Aid 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.	Usual Care n=478 Participants Clinicians and patients do not have access to the Head CT Decision Aid
Healthcare Utilization - Number of Tests Ordered Within 7 Days Evaluation and Management Codes for ED Visit	1.84 number of tests or procedures performed Standard Deviation 0.23	1.88 number of tests or procedures performed Standard Deviation 0.2
Healthcare Utilization - Number of Tests Ordered Within 7 Days Imaging	0.65 number of tests or procedures performed Standard Deviation 0.41	0.88 number of tests or procedures performed Standard Deviation 0.56
Healthcare Utilization - Number of Tests Ordered Within 7 Days Tests	0.41 number of tests or procedures performed Standard Deviation 0.32	0.7 number of tests or procedures performed Standard Deviation 0.55
Healthcare Utilization - Number of Tests Ordered Within 7 Days Procedures	0.17 number of tests or procedures performed Standard Deviation 0.13	0.26 number of tests or procedures performed Standard Deviation 0.19
Healthcare Utilization - Number of Tests Ordered Within 7 Days Other	0.23 number of tests or procedures performed Standard Deviation 0.28	0.38 number of tests or procedures performed Standard Deviation 0.46
Healthcare Utilization - Number of Tests Ordered Within 7 Days Unclassified	0.02 number of tests or procedures performed Standard Deviation 0.02	0.02 number of tests or procedures performed Standard Deviation 0.03

SECONDARY outcome

Timeframe: 7-days

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.

Outcome measures

Outcome measures
Measure	Decision Aid n=493 Participants Head CT Decision Aid 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.	Usual Care n=478 Participants Clinicians and patients do not have access to the Head CT Decision Aid
Rate of Clinically Important Traumatic Brain Injury (ciTBI)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1

Population: participants who consented to recording, and with a recording of sufficient quality to be scored

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.

Outcome measures

Outcome measures
Measure	Decision Aid n=267 Participants Head CT Decision Aid 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.	Usual Care n=249 Participants Clinicians and patients do not have access to the Head CT Decision Aid
Fidelity - Options for Care Decision aid brought into the room	259 Participants	0 Participants
Fidelity - Options for Care Decision aid used during the decision-making	251 Participants	0 Participants
Fidelity - Options for Care Decision aid was used by clinician alone	89 Participants	0 Participants
Fidelity - Options for Care Decision aid was shared with the parent/caregiver	157 Participants	0 Participants
Fidelity - Options for Care Undetermined decision aid use (audio recording)	5 Participants	0 Participants
Fidelity - Options for Care Clinician discuss any options for care	266 Participants	233 Participants
Fidelity - Options for Care Discussed option to get a CT scan now	257 Participants	196 Participants
Fidelity - Options for Care Discussed active observation at home	260 Participants	215 Participants
Fidelity - Options for Care Discussed option to let the ED clinician decide	14 Participants	1 Participants

Adverse Events

Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erik Hess

Mayo Clinic

Phone: 507-255-6501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place