Head InjuryNCT02063087
Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
A study testing Head CT Decision Aid in people with Head Injury, run by Mayo Clinic at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Head Injury
- What is being tested?
- Head CT Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 971 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Hospitals and Clinics of MN, Minneapolis
Minneapolis, Minnesota, 55404
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55454
Mayo Clinic
Rochester, Minnesota, 55905
University of California, Davis Medical Center
Sacramento, California, 95817
Children's Hospitals and Clincis of MN, St Paul ED
Saint Paul, Minnesota, 55102
About this study
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.
Read the 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.
- Conditions
- Head Injury
- Being tested
- Head CT Decision Aid
- Keywords
- Head CT, Head Injury, Pediatric, Emergency Department, Decision Aids, Shared Decision Making
- Medical subject headings
- Craniocerebral Trauma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid | Active comparator | Head CT Decision Aid Receives: Other: Head CT Decision Aid |
| Usual Care | No intervention | Clinicians and patients do not have access to the Head CT Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (immediately after the clinical encounter)
Secondary outcomes (8)
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.
Measured: Day 1 (during the ED visit)
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.
Measured: Day 1 (immediately after the clinical encounter)
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.
Measured: Day 1 (immediately after the clinical encounter)
Parental Satisfaction
The investigators will assess parents' satisfaction by comparing the number of patients who reported being "strongly satisfied" with their choice.
Measured: Day 1 (immediately after the clinical encounter)
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.
Measured: Day 1 (anytime during the index emergency department visit)
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.
Measured: 7-days
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.
Measured: 7-days
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 971 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, M. Fernanda Bellolio, Mayo Clinic
- Investigators
- M.Fernanda Bellolio, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063087
- Sponsor's protocol ID
- 13-004659
- Other IDs
- FP00071515
- Status last verified
- May 2019
- First submitted
- 13 Feb 2014
- Last updated
- 9 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19758692Hess 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.
PubMed 30646167Hess 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.
PubMed 24965659
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
- ClinicalTrials.gov ID
- NCT02063087
- Acronym / sponsor ID
- 13-004659
- Conditions
- Head Injury
- Keywords
- Head CT, Head Injury, Pediatric, Emergency Department, Decision Aids, Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 971 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- 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
- Study start
- Apr 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Posted 9 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid | Active comparator | Other: Head CT Decision AidHead CT Decision Aid |
| Usual Care | No intervention | –Clinicians and patients do not have access to the Head CT Decision Aid |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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:
- 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
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head CT Decision AidThe 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. | Other | Decision Aid |
Primary outcome
Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury
Time frame: Day 1 (immediately after the clinical encounter)
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.
8 secondary outcomes
Patient Engagement in the Decision-making Process
Time frame: Day 1 (during the ED visit)
Decisional Conflict
Time frame: Day 1 (immediately after the clinical encounter)
Trust in the Physician
Time frame: Day 1 (immediately after the clinical encounter)
Parental Satisfaction
Time frame: Day 1 (immediately after the clinical encounter)
Proportion of Children Who Undergo Head CT
Time frame: Day 1 (anytime during the index emergency department visit)
Healthcare Utilization - Number of Tests Ordered Within 7 Days
Time frame: 7-days
Rate of Clinically Important Traumatic Brain Injury (ciTBI)
Time frame: 7-days
Fidelity - Options for Care
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19758692Kuppermann 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.
- Derived from this study: PubMed 30646167Hess 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.
- Derived from this study: PubMed 24965659Hess 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M.Fernanda Bellolio, MD principal investigator
Mayo Clinic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head CT Decision Aid in people with Head Injury, run by Mayo Clinic at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury (time frame: Day 1 (immediately after the clinical encounter)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063087, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.