The Influence of a Proactive Palliative Care Intervention on Family Satisfaction and Biopsychosocial Problem-related Distress of Patients in a Surgical Intensive Care Unit: A Prospective Single-center Interventional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- family satisfaction in a surgical intensive care unit using a standardized questionnaire (FS-ICU).
研究概览
简要总结
Patients will be identified according to pre-defined trigger criteria for a palliative intervention. One hundred patients of a control group will receive standard intensive care treatment (Usual Care Group). Patients' biopsychosocial problem-related distress will be evaluated and family satisfaction with intensive care will be measured with standardized questionnaires. In the subsequent intervention part of the study one hundred patients will additionally be offered a palliative care treatment (Proactive Care Group) and patients' biopsychosocial problem-related distress as well as family satisfaction will also be evaluated.
详细描述
The project consists of different consecutive parts:
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Trigger criteria: Trigger criteria for patients with unmet palliative care needs in an intensive care unit have been specified prior to start of the clinical study by survey of staff of the surgical intensive care unit (intensivists and nursing staff): Trigger criteria include a) advanced cancer, b) multi-organ failure, c) severe cognitive impairment or dementia
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Clinical study: Proactive palliative care intervention vs. standard care for intensive care patients. Initially patients fulfilling the defined trigger criteria will be enrolled in the standard care group (Group 1). In the intervention part of the study, enrolled patients will be offered a set of different palliative care interventions in addition to standard intensive care (Group 2). In both groups, family satisfaction will be evaluated with the FS-ICU-24 (Family Satisfaction Intensive Care) questionnaire after discharge of the patients from the ICU. 8 weeks (60 days +/- 7 days) after inclusion in the study, patients' biopsychosocial distress will be assessed with standardized patient questionnaires (NCCN Distress thermometer, PHQ-2 Patient Health Questionnaire). One year after inclusion in the study, patients' functional status will be evaluated in a telephone interview using the Barthel Index. Planned duration of clinical part of the study: 3 years, thereof
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Patient-related:
Duration of palliative care intervention: approx. 60 mins for each patient contact. The number of interventions depends on the duration of ICU stay per patient. Follow-up per patient until 1 year after enrolment. 2. Study-related:
The clinical study starts with the enrollment of the first ICU patient. Data will be collected between the admission of the patient in the ICU until discharge from ICU and hospital discharge, respectively. Follow-up visits will be performed 8 weeks and 1 year after enrolment. Patients will be recruited over an estimated period of approx. 3 years, assuming that 1-2 patients per week can be included. Follow-up data will be collected up to 1 year after last patient in. 3. Termination of study including data analysis and evaluation, and publication of the study results: approx. 1 year
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
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
- •need for intensive care for more than 3 days and at least one of the following trigger criteria:
- •known advanced cancer
- •severe cognitive impairment or dementia
- •multi-organ failure
排除标准
- •Patients who already receive palliative care
研究组 & 干预措施
Usual Care Group
One hundred patients of a control group will receive standard intensive care treatment (Usual Care Group).
Proactive Palliative Care
One hundred patients will additionally be offered a palliative care Intervention (Proactive Palliative Care Group).
干预措施: Proactive Palliative Care (Other)
结局指标
主要结局
family satisfaction in a surgical intensive care unit using a standardized questionnaire (FS-ICU).
时间窗: after discharge from ICU, up to 1 year after enrolment
To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs on family satisfaction in a surgical intensive care unit using a standardized questionnaire (FS-ICU).
次要结局
- Duration of hospitalization(up to 1 year after enrolment)
- Patients' biopsychosocial problem-related distress after intensive care treatment measured with the NCCN distress thermometer(60 days +/- 7 days after enrolment)
- Intensive care length of stay(up to 1 year after enrolment)
- 1-year Patient survival(up to 1 year after enrolment)
- Organ replacement therapy(up to 1 year after enrolment)
- Functional assessment after 1 year(up to 1 year after enrolment)
研究者
Rita Laufenberg-Feldmann, M.D.
Anaesthesiologist, Head of Clinical Trial Unit
Johannes Gutenberg University Mainz