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临床试验/NCT03995381
NCT03995381Unknown不适用

Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis: A Randomized Controlled Trial

Taipei Medical University Shuang Ho Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Decisional conflict

研究概览

简要总结

Vascular closure device, hemostatic bandage and manual compression can achieve hemostasis after angiographic examination. These three methods of hemostasis changed the rate of hemostasis, early ambulation, hematoma , hemostasis failure rate, and expense. Therefore, shared decision making (SDM) is necessary to aid patients to choose hemostasis.The investigators have developed a decision aids (DA) and planned a randomized controlled trial (RCT) to evaluate its impact on angiographic patients. The measurements include a battery of interview-based questionnaires and evaluations of decision conflicts. The investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and choice conflicts.during and after thier Hemostasis procedure.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who needs an angiographic examination or treatment.
  • Patients with angiographic indications
  • Patients who were able to give consent and complete the interview

排除标准

  • The angiographic procedure uses patients with a catheter size more than 7fr.
  • Patients in critical situations requiring urgent treatment
  • Patients had cognitive impairment
  • Patients were physically unfit to be interviewed
  • Patients were non-Mandarin or -Taiwanese

研究组 & 干预措施

DAs group

Experimental

Shared decision making using decision aids

干预措施: Decision aids (Other)

Control group

No Intervention

Standard oral explanation guided with booklets

结局指标

主要结局

Decisional conflict

时间窗: 1 hour before Angiography

Total score of decisional conflict scale

次要结局

未报告次要终点

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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