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

N/ACompletedNCT02063087

Mayo Clinic971 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

971

Conditions

Head Injury

Interventions

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.

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

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.

Time frame: Day 1 (immediately after the clinical encounter)

Secondary Outcomes

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.

Time frame: 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.

Time frame: Day 1 (immediately after the clinical encounter)

Data from ClinicalTrials.gov

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