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临床试验/NCT02611050
NCT02611050终止不适用

Treatment Decisions for Multi-vessel Coronary Artery Disease Patients

Dartmouth-Hitchcock Medical Center8 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2015年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
14
试验地点
8
主要终点
Patient Decisional Conflict

研究概览

简要总结

This study is a multi-center randomized trial to evaluate the Multi-vessel Coronary Artery Disease Option Grid patient decision aid compared to usual care in patient reported decisional conflict, knowledge, and shared decision making.

详细描述

Multi-vessel coronary artery disease can be treated through percutaneous coronary intervention, coronary artery bypass grafting, or medical therapy. Treatments have risk benefit tradeoffs, making patient preference integral to the treatment decision. The Multi-vessel Coronary Artery Disease Option Grid patient decision aid was developed to improve the decision making process for patients and clinicians.

Objectives:

  1. Evaluate The Multi-vessel Coronary Artery Disease Option Grid impact on patient treatment decisional conflict, knowledge, and shared decision making.

The randomized controlled trial will compare validated and standardized measures of patient decisional conflict, shared decision making, and condition specific treatment knowledge between Option Grid and usual care patients. The investigators hypothesize Option Grid patients will have improvements in patient decisional conflict, shared decision making, and knowledge compared to usual care patients. Baseline feasibility enrollment at each site prior to randomization will be used to identify current treatment patterns, and prepare intervention delivery and fidelity. Registry data will be used to identify patient treatment received and compared between Option Grid and usual care arms. 2. Examine the physician and patient process of and factors influencing Multi-vessel Coronary Artery Disease Option Grid use.

Semi-structured interviews and process evaluations will be used to describe Option Grid use and experience and identify factors that are associated with beneficial Option Grid use.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable multi-vessel coronary artery disease diagnosed by coronary angiography defined as left main disease (>50% stenosis) or multi-vessel coronary artery disease (>70% stenosis in two or more coronary arteries)
  • At relative equipoise for at least two potential treatment options, in which the treating cardiologist or surgeon has determined the treatments are anatomically feasible and safe.

排除标准

  • Prior coronary artery bypass grafting
  • Unable to read or write English
  • Not cognitively able to participate in the Option Grid as determined by clinician

研究组 & 干预措施

Option Grid

Experimental

Patients randomized to the Option Grid arm will receive the Multi-vessel Coronary Artery Disease Option Grid at the time of enrollment. The treating physician will then discuss the patient diagnosis and treatment choice reviewing the Option Grid within the conversation to facilitate patient understanding and shared decision making

干预措施: The Multi-vessel Coronary Artery Disease Option Grid (Behavioral)

Usual Care

Other

Patients randomized to usual care will discuss the patient diagnosis and treatment options typical to the physician's routine care.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Patient Decisional Conflict

时间窗: Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.

The Ottawa Decisional Conflict Scale is a validated measure of a patient's feeling of conflict with the decision making experience

次要结局

  • CollaboRATE Score(Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.)
  • Clinician Experience(Within five days of the clinical discussion)
  • Patient Experience(Within five days of the clinical discussion)
  • Treatment Received(Within 1 month of clinical discussion)
  • Treatment Knowledge(Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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