Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission.
研究概览
简要总结
In unstable patients needing oxygen and/or home mechanical ventilation, a nurse-centred TM programme (supported by continuous availability of a call centre and a pulsed oxygen system) is cost/effective saving health care resources.
详细描述
Background: Integrated care and strict follow up have been recommended for frail patients with chronic respiratory failure (CRF) discharged at home.
Objectives: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged at home with oxygen and/or home mechanical ventilation (HMV) with a high risk of hospital readmission.
Design: Prospective randomised controlled trial. Setting: Respiratory Rehabilitation Unit S. Maugeri Foundation between May 2004 and March 2007.
Participants: 240 CRF patients will be randomised into an intervention group (TM) and a control Group, which received current usual care (educational plan, 3 months outpatient visits).
Interventions: one year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing.
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
- None
入排标准
- 年龄范围
- 12 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CRF patients discharged from Respiratory Unit with home MV
排除标准
- •Severe co morbid conditions, i.e. lung cancer or other advanced malignancies, and extremely severe neurological disorders (with impaired cognitive status, ability to understand medical instructions, dementia or severe psychiatric illness)
- •Logistical limitations due to extremely poor social conditions, such as illiteracy or no telephone access at home
- •Being admitted to a nursing home
- •Lack of caregiver when ventilated invasively (i.e. tracheal cannula with sounds uncertain) to allow a contact between care team and family
- •Refusal to give informed consent
结局指标
主要结局
To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission.
时间窗: 3 years
次要结局
未报告次要终点
研究者
Michele Vitacca
Fondazione Salvatore Maugeri
Fondazione Salvatore Maugeri