Quasi-experimental Before-and-after Study to Compare the Effectiveness of Geriatric Co-management on Preventing Functional Decline as Compared to Standard of Care in Older Cardiology Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 2
- 主要终点
- Functional status on activities of daily living assessed using the Katz Index of Activities of Daily Living.
研究概览
简要总结
The primary objective of the evaluation study is to determine if geriatric co-management is superior to standard of care in preventing functional decline in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven.
详细描述
This study aims to implement and evaluate a geriatric co-management intervention in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven. The study uses a mixed-methods methodology aiming to 1) assess the feasibility and evaluate the effectiveness of geriatric co-management, 2) describe the experiences of intervention participants, and 3) perform a process evaluation. We will first consecutively recruit patients on the cardiology units to measure the standard of care in the control group. The geriatric co-management intervention will then be implemented and piloted on the participating units. Once fully implemented, we will consecutively recruit patients for the intervention group who will receive the geriatric co-management intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included if they:
- •Are admitted for non-surgical treatment of an acute heart problem (patients may be admitted through the emergency department or the cardiology outpatient services for any heart related acute disease) OR if they are admitted for Transcatheter Aortic Valve Implantation (TAVI);
- •Are aged 75 years or older;
- •Have an expected length of stay of three days or longer;
- •Non-palliative on hospital admission
- •Are Dutch speaking and testable;
- •Give informed consent or proxy-informed consent;
排除标准
- •Patients will be excluded if they:
- •Are admitted from another hospital unit or other hospital;
- •Have been admitted to the intensive care unit for three days or longer;
结局指标
主要结局
Functional status on activities of daily living assessed using the Katz Index of Activities of Daily Living.
时间窗: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
A difference of 1 point on the Katz Index will be considered clinically relevant.
Functional decline in activities of daily living assessed using the Katz Index of Activities of Daily Living
时间窗: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
A decline of 1 point between admission and discharge on the Katz Index will be considered clinically relevant.
次要结局
- Short Physical Performance Test (SPPB).(Hospital admission (baseline), up to at hospital discharge around an average of 12 days.)
- Delirium assessed using the 3D confusion assessment method.(Hospital admission (baseline) and on day 3, 5, 7 and 9 (or every day when a patient is delirious).)
- Length of hospital stay.(Hospital admission (baseline) up to hospital discharge around an average of 12 days.)
- Institutionalization.(hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.)
- Thirty day unplanned readmission rate.(30 days follow-up after hospital discharge.)
- Quality of life assessed using the EQ-5D.(Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.)
- Functional status on activities of daily living assessed using the Katz Index of Activities of Daily Living.(At 30 days, 3 months and 6 months follow-up after hospital discharge.)
- Hospital costs(Between hospital admission and discharge, an average of 12 days)
- Functional decline in activities of daily living assessed using the Barthel Index of Activities of daily. Living.(Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.)
- Unplanned hospital readmissions(up to 6 months follow-up after hospital discharge)
- Community mobility assessed using the Life-Space assessment.(Hospital admission (baseline), and at 30 days, 3 months and 6 months follow-up after hospital discharge.)
- Peak handgrip force assessed at the dominant side with the elbow at 90° of flexion, and the forearm and wrist in a neutral position.(Hospital admission (baseline) up to hospital discharge around an average of 12 days.)
- Falls and fall related injuries.(Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.)
- Obstipation assessed using nurses recorded observations.(Hospital admission (baseline) up to hospital discharge around an average of 12 days.)
- Survival(Hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.)
- Symptomatic infections defined by a clinical diagnosis of pneumonia, urinary tract infection, sepsis and wound infection.(Hospital admission (baseline) up to hospital discharge around an average of 12 days.)
- Cognitive status assessed using the Mini-Cog.(Hospital admission (baseline) up to hospital discharge around an average of 12 days.)
- Quality of life index assessed by converting the EQ-5D using standardized index values.(Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.)