King County Lung Injury Project: Survivor Outcome Study (KCLIP:SOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Scores for quality of life measures
研究概览
简要总结
King County Lung Injury Project: Survivor Outcome Study (KCLIP:SOS) is a randomized trial for individuals who have survived prolonged mechanical ventilation (5 days or more). The objective is to enroll individuals who are likely to have impaired health status resulting from prolonged critical illness but whose long term prognosis is good. Such individuals are most likely to benefit from the study intervention of case management targeted at post intensive care complications.
KCLIP:SOS will test whether an outpatient intervention based on a nurse using a targeted case management tool can reduce patient morbidity and improve quality of life in the 6 months following hospital discharge. This intervention will be compared to usual post-hospital care.
详细描述
BACKGROUND:
The purpose of this study is to understand individuals' physical and emotional conditions and concerns after being ventilated in the hospital. Modern hospital care helps many people survive even if they are on ventilators for long periods of time. Some individuals who leave the hospital after this kind of intensive care suffer from depression, post-traumatic stress disorder, muscle weakness, tiredness or breathing difficulties that may decrease their quality of life. Doctors know little about finding and treating these problems in survivors of mechanical ventilation.
DESIGN NARRATIVE:
Participants will be randomly assigned in blocks of 10 (5 participants to usual care and 5 participants to case management) for home or skilled nursing facility discharges. The Outcome Assessors (the interviewers collecting outcomes data) will be blinded to group assignment.
Primary outcome: All participants will have a baseline interview soon after hospital discharge and a final interview at the end of the 6-month intervention period (outcome assessments). All subjects will be asked to keep a diary/journal of their medical appointments, health services, and medications. Participants will be called once a month to collect this information.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On a ventilator for 5 or more days
- •Expected to survive the 6 months post-hospital discharge period
- •Lives in the SOS zip code area (King, Pierce and Snohomish counties)
排除标准
- •Severe pre-hospital health conditions
- •Lack of availability for follow-up (e.g. homeless, chronic substance abuse)
- •Non-English speakers
- •Severe psychiatric issues
- •Need for special rehabilitation services not available in the intervention
- •Predicted survival of less than 6 months
研究组 & 干预措施
1
Targeted nurse case management
干预措施: Targeted Case Management (Behavioral)
2
Usual Care
干预措施: Usual care (Behavioral)
结局指标
主要结局
Scores for quality of life measures
时间窗: 6 months
次要结局
未报告次要终点
研究者
Elizabeth Parsons
Assistant Professor, SOM: Department of Medicine: Pulmonary, Critical Care and Sleep Medicine
University of Washington