Preoperative RIsk Assessment and Shared Decision-Making in Patients Eligible for Cardiac Surgery (PRIME-study): a Study Protocol for a Single Center Non-randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The difference between the treatment recommendation provided by the multidisciplinary Heart Team prior to the patients visit to the PRIME-clinic and the treatment advice from the Heart Team after the patients visit to the PRIME-clinic.
研究概览
简要总结
The goal of this study is to determine whether intervention by the PRIME clinic influences cardiac treatment decisions, as well as patients quality of life and healthcare utilization.
The main questions this study aims to answer are:
- Does PRIME consultation influence treatment recommendations?
- Does a personalized treatment plan for cardiac patients influence health-related quality of life?
- Does a personalized treatment plan influence healthcare costs (in terms of quality-adjusted life years)?
Participants will:
- Visit the PRIME clinic once
- Complete quality of life questionnaires twice
- Track their healthcare usage over the course of a year and complete a corresponding questionnaire four times.
详细描述
The primary outcome of this study is the difference between treatment recommendations; the first treatment recommendation (the decision before the patient visits the outpatient clinic) will be compared with the treatment recommendation after the assessment at the outpatient clinic.
Secondary and other outcomes that will be collected are baseline demographic data including age, gender, body mass index, education level, European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and co-morbidities such as stroke, reduced cognitive function, chronic obstructive pulmonary disease (COPD) GOLD III or IV, renal failure (a reduced renal function prior to surgery with a kreatinine level ≥150mmol/L), a reduced left ventricular function, reduced mobility, cardiac reoperation and type of surgical procedure (CABG, valve replacement or repair, surgery of the thoracic aorta or a combination of several procedures).
Data will be collected using several questionnaires:
- Health-related Quality of Life (the RAND-36 questionnaire)
- The Katz Index of Independence in Activities of Daily Living to assess functional status
- The Cognitive Impairment Test
- The Timed Up and Go Test
- Outcome Prioritization Tool to assess the most important goals of treatment The RAND-36 and KATZ-ADL will be completed by all patients, including those receiving standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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 and older
- •Eligible for cardiac surgery
- •Having two or more risk factors: stroke; reduced cognitive function; Chronic Obstructive Pulmonary Disease (COPD); obesity; reduced left ventricular ejection fraction; renal failure; reduced mobility; cardiac reoperation; and the complexity of the procedure.
排除标准
- •Unable to read or understand Dutch
结局指标
主要结局
The difference between the treatment recommendation provided by the multidisciplinary Heart Team prior to the patients visit to the PRIME-clinic and the treatment advice from the Heart Team after the patients visit to the PRIME-clinic.
时间窗: From enrollment to the second treatment advice of the heart team, typically within 8 weeks. .
After the patient is referred to the UMCG, the patients situation is discussed by the heart team, resulting in a treatment recommendation, which is documented in the electronic patient record. If the patient meets the inclusion criteria for the PRIME-study, they will also be invited to the PRIME-clinic (usually within a week). The findings from the PRIME-clinic are then discussed the same day during the heart team meeting, after which a treatment recommendation is formulated again. A difference in treatment recommendation is noted when the initial recommendation is revised, opting for a less invasive or conservative treatment instead of open-heart surgery.
次要结局
- Health related quality of life, SF-36(From enrollment to one year after)
- The cost-effectiveness ratio, an analysis that combines both the EQ-5D-5L (for health gains) and the Medical Cost Questionnaire (for costs)(From enrollment to one year after)