Interdisciplinary and Cross-sectoral Perioperative Care Model in the Cardiac Surgery: Implementation in the Setting of Minimally-invasive Heart Valve Surgery (INCREASE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 4
- 主要终点
- Six Minute Walk Test
研究概览
简要总结
Valvular heart diseases are among the most common cardiac pathologies in adult patients in Germany. Currently, the process of care before, during and after heart valve surgery does not follow a standardized and interdisciplinary optimal approach. An approach already established in other surgical disciplines is the Enhanced Recovery After Surgery (ERAS) protocol, which aims at optimizing the recovery process of patients. Within the INCREASE study, a care process inspired by the ERAS protocol will be established at the University Heart and Vascular Center (UHZ) of the University Medical Center Hamburg-Eppendorf (UKE) and the University Medical Center Augsburg (UKA). Executing the study at two facilities in different regions in Germany will help to demonstrate transferability of the process of care. The effectiveness of this process compared to the current treatment approach will be investigated in a randomized controlled trial. A total of 186 patients will be allocated by chance either to the intervention group (ERAS protocol) or the control group (treatment as usual). Patients in the intervention group will receive an optimized interdisciplinary care protocol including medical, nursing, physiotherapeutical and psychotherapeutical interventions. Measurements of effectiveness are the number of hospitalized days (due to cardiac causes) within one year and the physical condition of the patient as measured by the 6-minute walk test (6MWT) on the day of discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
All scientists and statisticans involved in the analysis of the study will be blinded to the allocation of participants and will receive only pseudomized data from the study coordinator, who organises data collection.
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
- •Indication for elective minimally invasive (open) aortic or mitral valve surgery
- •Patient's ability to understand the nature and extent of the individual's requirements for participation in the new care setting
- •Classification of the patient as "FIT" or "Pre-FRAIL" using the LUCAS functional index (frailty index) (Dapp et al. 2012)
排除标准
- •Limited life expectancy less than one year (e.g., advanced tumor disease)
- •Urgent or emergency interventions
- •Severe chronic obstructive pulmonary disease (GOLD III or IV)
- •Dialysis-dependant renal failure
- •Advanced liver cirrhosis (Child stages B + C)
- •Severe comorbidities or psychosocial reasons that militate against participation or do not allow for written informed consent (e. g., residual neurological impairment after prior stroke, major restrictions of mobility, neuropsychological disorders, depressive disorder, substance-related addictive disorders)
- •Lack of a social environment that can provide supportive patient care
- •Previous cardiac surgery (i.e., relative contraindication for minimally invasive technique)
结局指标
主要结局
Six Minute Walk Test
时间窗: day of discharge (approx. 5 - 10 days after operation)
physical capacity expressed with the walking distance in meters
Hospitalization
时间窗: twelve months
number of hospitalized days due to cardiac reasons
次要结局
- Goal Attainment Scale (GAS)(twelve months)
- HeartQoL(twelve months)
- Costs(up to 10 days)
研究者
Evaldas Girdauskas
Prof. Dr. med.
Universitätsklinikum Hamburg-Eppendorf