Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Patient decisional conflict
研究概览
简要总结
Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality.
The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR.
TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years
- •Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area <0.6cm2/m2
- •Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision
排除标准
- •Life expectancy <1 year irrespective of valvular heart disease
- •Inability to provide informed consent
- •Participation in another clinical trial with an active intervention
研究组 & 干预措施
Structured SDM
Structured shared decision making for the choice between SAVR and TAVR
干预措施: Structured SDM (Other)
Usual Care
Usual care for the choice between SAVR and TAVR
干预措施: Usual Care (Other)
结局指标
主要结局
Patient decisional conflict
时间窗: 3 days post baseline visit
Assessed by decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Patient decisional regret
时间窗: 30 days post TAVR/SAVR
Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
次要结局
- The incidences of major clinical adverse events(30 days and 1 year post TAVR/SAVR)
- Patient knowledge about the treatment options and outcomes(3 days post baseline visit)
- Patient decisional satisfaction(3 days post baseline visit; 30 days and 1 year post TAVR/SAVR)
- Quality of choice(3 days post baseline visit)
- Patient health-related quality of life(30 days post TAVR/SAVR)
- The proportion of patients choosing TAVR/SAVR(Baseline)
- Patient-centered communication(3 days post baseline visit)
- Patient procedural satisfaction(3 days post baseline visit)
- Patient feeling of not being informed(3 days post baseline visit)
- Incorporation of patient values(3 days post baseline visit)
- Patient decisional regret(1 year post TAVR/SAVR)