Influence of Quality of Care and Individual Patient Characteristics on Quality of Life/ Return to Work in Survivors of the Acute Respiratory Distress Syndrome (ARDS): Prospective, Observational, Multi-centre Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 3
- 主要终点
- Health-related quality of life, measured by the Short-Form 12-item Health-Survey (SF-12)
研究概览
简要总结
The purpose of the DACAPO study ("Surviving ARDS: the influence of quality of care and individual patient characteristics on quality of life") is to investigate the role of quality of care and individual patient characteristics on quality of life and return to work in survivors of ARDS (acute respiratory distress syndrome). It is hypothesized that higher quality of care is associated with better health-related quality of life and a higher rate of return to work among survivors.
A prospective, observational, multi-centre patient cohort study is performed in Germany, using hospitals from the "ARDS Network Germany" as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyze a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. Quality of care will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (health related quality of life and return to work) will be gathered by self-report questionnaires. Further data assessment includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of quality of care and individual patient characteristics on outcomes, taking the cluster structure of the data into account.
详细描述
Design Patients will be included in the study at the beginning of ICU stay in a participating hospital (t0) and survivors will be followed over a period of 12 months after discharge from ICU. If patients have been treated before in a referring hospital, a retrospective assessment of their health status during their stay in this hospital and during inter-hospital transport will be performed. Four follow-up measurements (at discharge from ICU as well as 3, 6 and 12 months after discharge) will be performed on individual patient level.
Sample & Recruitment Hospitals of the "ARDS Network Germany" and other hospitals which provide care for patients with ARDS were invited to participate in the study.
It is envisaged to screen 2600 patients for the presence of ARDS and to include 2400 patients as members of the source population. An in-hospital mortality rate of 30% is assumed; therefore, we expect to analyze a study population of 1500 patients at t1 (discharge from ICU). For each follow-up-assessment (t2-t4: 3 months, 6 months, 12 months after discharge), loss-to-follow-up rates due to death, withdrawal of consent or other reasons are estimated to be about 10%, resulting in slightly more than 1000 patients at 12-months-follow-up.
Measurements The main predictor is quality of care provided in the ICUs of the participating hospitals. The following main indicators were chosen: qualification of physicians, implementation of routine daily multiprofessional ward rounds with documentation of daily therapy goals, number of ventilated patients per, and membership of the hospital in the "ARDS Network Germany". All quality indicators will be assessed by questionnaire at the institutional level.
Main outcome measures of the DACAPO study are HRQoL and return to work among survivors of ARDS (see study outcomes).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ARDS according to the criteria of the Berlin-Definition:
- •i) Acute onset within one week, ii) bilateral pulmonary infiltrates (chest imaging), iii) respiratory failure not fully explained by cardiac failure or fluid overload.
- •informed consent provided by the patient or the legal guardian
- •18 years old or older
排除标准
- •no informed consent provided by the patient or the legal guardian
- •younger than 18 years
结局指标
主要结局
Health-related quality of life, measured by the Short-Form 12-item Health-Survey (SF-12)
时间窗: 3 months, 6 months, 12 months after discharge from the ICU
change from baseline (discharge from the ICU) to 3 months, 6 months and 12 months, respectively.
次要结局
- return to work(3 months, 6 months, 12 months after discharge from the ICU)
研究者
Prof. Dr. Thomas Bein M.A.
Principal Investigator
University Hospital Regensburg