Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 971
- 试验地点
- 14
- 主要终点
- Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Decision Aid
Head CT Decision Aid
干预措施: Head CT Decision Aid (Other)
Usual Care
Clinicians and patients do not have access to the Head CT Decision Aid
结局指标
主要结局
Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury
时间窗: 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.
次要结局
- Patient Engagement in the Decision-making Process(Day 1 (during the ED visit))
- Decisional Conflict(Day 1 (immediately after the clinical encounter))
- Proportion of Children Who Undergo Head CT(Day 1 (anytime during the index emergency department visit))
- Healthcare Utilization - Number of Tests Ordered Within 7 Days(7-days)
- Fidelity - Options for Care(Day 1)
- Trust in the Physician(Day 1 (immediately after the clinical encounter))
- Parental Satisfaction(Day 1 (immediately after the clinical encounter))
- Rate of Clinically Important Traumatic Brain Injury (ciTBI)(7-days)
研究者
M. Fernanda Bellolio
Principle Investigator
Mayo Clinic