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

NCT ID: NCT02063087

Last Updated: 2019-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 971 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-01-31

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.

Conditions

Head Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Decision Aid

Head CT Decision Aid

Group Type: ACTIVE_COMPARATOR

Head CT Decision Aid

Intervention Type: OTHER

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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. 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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

University of Minnesota Masonic Children's Hospital

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

Flying Buttress Associates

UNKNOWN

Sponsor Role: collaborator

Children's Hospitals and Clinics of Minnesota

OTHER

Sponsor Role: collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

M. Fernanda Bellolio

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M.Fernanda Bellolio, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

University of California, Davis Medical Center

Sacramento, California, United States

Boston Children's Hospital

Boston, Massachusetts, 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

Children's Hospitals and Clincis of MN, St Paul ED

Saint Paul, Minnesota, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19758692 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30646167 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24965659 (View on PubMed)

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

FP00071515

Identifier Type: OTHER

Identifier Source: secondary_id

13-004659

Identifier Type: -

Identifier Source: org_study_id