A Pilot Randomized Trial of a Decision Aid in CTO Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 主要终点
- patient knowledge regarding CTO of PCI or medication (risk and benefit)
研究概览
简要总结
The aim of this study is to assess the feasibility and validity of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.
详细描述
This is a parallel, 2-arm, randomized trial to compare an intervention group receiving CTO Choice (decision aid) to a control group receiving usual primary care. 100 patients and 60 cardiologists will be randomize by computer. The investigators will measure the effect of CTO Choice on five outcomes: (a) patient knowledge regarding CTO of PCI or medication (risk and benefit); (b) quality of the decision making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of percutaneous coronary intervention (PCI) or medication; and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, the investigators will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians exposed to the decision aid were able to recreate elements of the decision aid which control patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Inclusion Criteria:
- •At least one lesion occluding the coronary artery detected by angiography or MSCTA.
- •left ventricular ejection fraction ≥ 40% on transthoracic echocardiography measurement.
- •No major barriers to provide written consent.
排除标准
- •Severe coexisting conditions, such as severe renal insufficiency (GFR < 30 ml/min•1.73m2), severe hepatic dysfunction [elevated glutamic-pyruvic transaminase or glutamic-oxal acetic transaminase level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
- •Patients with cognitive impairment, severe hearing loss, or visual impairment who could not complete the survey.
- •Cardiologist:
- •Inclusion Criteria:
- •Doctors who work in the department of Cardiology for more than 1 years.
- •No major barriers to provide written consent.
- •Exclusion Criteria:
研究组 & 干预措施
intervention group
Patients in this group will receive CTO Choice (decision aid).
干预措施: decision aid (Other)
control group
Patients in this group will receive usual primary care.
结局指标
主要结局
patient knowledge regarding CTO of PCI or medication (risk and benefit)
时间窗: within the first 3 days after survey
次要结局
- quality of the decision making process for both the study subjects(within the first 3 days after survey)
- subjects acceptability with the decision aid(within the first 3 days after survey)
- rate of PCI or medication(within the first 3 days after survey)
- ability to recruit participants(within the first 3 days after survey)