Accuracy of a New Simplified Screening Tool in Identifying the In-hospital Patients in Need of Palliative Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- Accuracy of the Simplified Screening Tool (SST) with respect to the SIAARTI/NCCN screening tool (EST)
研究概览
简要总结
Every day many patients affected by chronic life-limiting illnesses are admitted into Internal Medicine wards, coming from the Emergency Department. Many studies suggest that providing palliative care to these patients may improve their end-of-life care while reducing costs by minimizing futile treatments and unwanted intensive care unit admissions. Consequently, there is a strong need for acute care hospitals to more vigorously identify patients entering the final phase of their lives as well as their specific care needs.
In a previous study the investigators screened for need of palliative care patients affected by progressive chronic diseases by means of a tool, based on the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care - SIAARTI - position paper reporting criteria for patients with end-stage chronic organ failures, and on the specific clinical indicators elaborated by the National Comprehensive Cancer Network (NCCN) for patients with locally advanced/metastatic cancer. In a further pilot study, the investigators compared the outcomes of PC patients depending on whether the palliative care team evaluated such patients only if requested by the physician staff or routinely, irrespectively of a specific request, finding a significant increase of discharges after the activation of an appropriate PC service or scheduled PC ambulatory visit.
In the present study the investigators enroll chronically ill patients admitted to an Internal Medicine Unit from the Emergency Department, to be screened for palliative care need, using the previously cited SIAARTI/NCCN screening tool (Extended Screening Tool - EST), or using a Simplified Screening Tool (SST), derived from the first instrument, which preliminary showed a superimposable efficacy. This latter tool has advantages related to much more shortness and therefore simplicity in the administration to a seriously ill patient and is much less time consuming, allowing the physician to use it routinely.
The aim of the study is to verify the accuracy of the SST in identifying chronically ill patients in need of a PC approach, in comparison to the SIAARTI/NCCN tool (EST). If the SST would show good accuracy, an easily manageable tool for the assessment of PC needs in chronically ill patients would be available for the daily routine.
详细描述
Due to population aging and advances in medicine and public health, the prevalence of people affected by progressive, chronic, life-limiting diseases is increasing. Many studies documented that patients with progressive chronic diseases received care that was more aimed at the prolongation of life than palliation of symptoms during their last 6-12 months of life, as well as frequent hospitalizations. These data suggested that providing palliative care (PC) to these patients may improve their end-of-life care while reducing costs by minimizing futile treatments and unwanted ICU care.
Consequently, there is a strong need for acute care hospitals to more vigorously identify patients entering the final phase of their lives as well as their specific care needs.
Historically, Hospice and PC services have focused on the needs of cancer patients. However, the majority of patients needing PC worldwide suffer from life-limiting non-cancer illnesses, like cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal failure, cirrhosis of the liver, Alzheimer's and other dementias, multiple sclerosis, Parkinson's disease, HIV/AIDS, rheumatoid arthritis, and diabetes. The main illnesses requiring PC are cardiovascular diseases (38%), cancer (34%), and COPD (10%).
In order to correctly identify such patients, adequate screening tools are needed.
In a previous study, the investigators employed for this aim a screening tool derived from the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care (SIAARTI) position paper based on expert panel opinions reporting criteria to identify patients with end-stage chronic organ failures. For cancer patients, the screening was done according to specific clinical indicators elaborated by the National Comprehensive Cancer Network (NCCN). A Simplified Screening Tool was also created, in order to make available an easier instrument for the same aim.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
The Principal Investigator provided close envelops containing the SIAARTI/NCCN screening tool or the Simplified Screening Tool. The screening tool was inserted in the envelop according with a randomization list. The sub-investigator who wold examine the patient had to take the close envelope marked with the corresponding progressive number of patient enrolled, without possibility of choose the tool.
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
- •Patients admitted to Molinette Hospital (A.O.U. "Città della Salute e della Scienza"), affected by:
- •locally advanced/metastatic cancer not suitable to antineoplastic therapy
- •locally advanced/metastatic cancer suitable for palliative antineoplastic therapy
- •locally advanced/metastatic cancer with uncontrolled symptoms
- •end-stage heart failure
- •end-stage respiratory failure
- •end-stage liver failure
- •end-stage renal failure
排除标准
- •not able to be administered the screening tool
- •major psychiatric disorders
- •informed consent refusal
研究组 & 干预措施
Extended Screening Tool (EST)
The SIAARTI/NCCN (EST) screening tool is, in fact, an instrument validated by many scientific societies, but it is very articulated and its compilation is too much time-consuming.
干预措施: Screening for PC by means of two different screening tools (Other)
Simplified Screening Tool (SST)
The Simplified Screening Tool (SST) has been created through a statistical process in order to include all the critical variables, with the advantage of being shorter and therefore easier to administer in a routinely use.
干预措施: Screening for PC by means of two different screening tools (Other)
结局指标
主要结局
Accuracy of the Simplified Screening Tool (SST) with respect to the SIAARTI/NCCN screening tool (EST)
时间窗: Through study completion, an average of 1 year
BACKGROUND: The aims of this study were to evaluate the feasibility of an Emergency Department (ED)-initiated screening to identify seriously ill patients in need of palliative care (PC) and to develop a simplified screening tool (SST). METHODS: Eligible patients with a known diagnosis of chronic heart, lung, liver, and kidney failures, or advanced cancer, awaiting to be hospitalized after an ED visit, were assessed with both screening tools (ie, EST and SST). The outcome of this study is to evaluate the accuracy of the SST in identifying chronically ill patients in need of a palliative care assessment in the hospital setting.
次要结局
- Intensity of symptoms in patients admitted in an acute palliative care unit(Through study completion, an average of 1 year)
- Accuracy of Surprise Question (SQ)(Through study completion, an average of 1 year)
- Symptom control in palliative care patients(Through study completion, an average of 1 year)
- Survival of patients in need of palliative care assessment(Through study completion, an average of 1 year)
- Clinical characteristics and outcomes of palliative care patients referred to an acute palliative care unit(Through study completion, an average of 1 year)
- Discharge and unplanned hospital readmissions of patients in need of palliative care assessment(Through study completion, an average of 1 year)
研究者
Paolo Cotogni
Head of Acute Palliative Care Unit and Palliative Care Team
A.O.U. Città della Salute e della Scienza