Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 898
- 试验地点
- 9
- 主要终点
- Test if Chest Pain Choice Safely Improves Patient Knowledge.
研究概览
简要总结
Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following:
- Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial.
Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events. 2. Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment.
Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years of age (at least 18).
- •Admitted to emergency department for chest pain.
- •Being considered by the treating clinician for admission for cardiac testing.
排除标准
- •Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
- •Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
- •Known coronary artery disease as defined by consensus guidelines on risk stratification studies for emergency department patients with potential acute coronary syndrome (≥ 50% stenosis on cardiac catheterization; prior electrocardiographic changes indicative of ischemia, e.g., ST-segment depression, T-wave inversion, or left bundle branch block; perfusion defects or wall motion abnormalities on previous exercise, pharmacological, or rest imaging studies; previous documentation of acute myocardial infarction; or, if no records are available, patient self-report of coronary artery disease).
- •Cocaine use within the previous 72 hours by clinician history.
- •Referral to the emergency department by a personal physician for admission.
- •Patients who indicate that a hospital different than the site hospital is his or her "hospital of choice" in the event of a return emergency department visit.
- •Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
- •Homelessness, out-of-town residence or other condition known to preclude follow-up.
- •Patients in police custody or currently incarcerated individuals.
- •Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid).
结局指标
主要结局
Test if Chest Pain Choice Safely Improves Patient Knowledge.
时间窗: Directly following intervention (on day 1)
Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.
次要结局
- Decisional Conflict(Immediately after the visit (day 1))
- Total Testing Within 45 Days (a Component of Healthcare Utilization)(45 days)
- Physician Trust(Immediately after the visit (day 1))
- Major Adverse Cardiac Event (MACE)(within 30 days of enrollment)
- Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.(Within 30 days of study enrollment)
- Test if the Decision Aid Safely Improves Patient Engagement.(Immediately after the intervention (on day 1))
研究者
Erik P. Hess
MD, MSc, Principal Investigator
Mayo Clinic