Validation and Evaluation of the CUDECA Cui-DAR Plan in People With Oncological and Non-oncological Diseases in the Last Days of Their Lives (CUIDARCUDECA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 348
- 试验地点
- 3
- 主要终点
- Number of patients with oncological and non-oncological diseases who are at the end of their lives and have been evaluated with the CUDECA Cui-DAR Plan for the care of symptoms and signs.
研究概览
简要总结
Cudeca, an independent non-profit organization located in Malaga (Spain), treats patients with advanced and terminal disease. It has developed Cui-DAR Cudeca plan, a care plan for the care of patients in situations of last days of thier live that integrates in a single document, all the assessments and multidisciplinary actions necessary, from the beginning of last days situation, to the care after death. The objective of the study is to evaluate the validity and effectiveness of the Cui-DAR CUDECA Plan in people in a situation of last days compared to conventional care in the assessment of symptoms and signs.
详细描述
Cudeca, an independent non-profit organization located in Malaga (Spain), treats patients with advanced and terminal disease. It has developed Cui-DAR Cudeca plan, a care plan for the care of patients in situations of last days of thier live that integrates in a single document, all the assessments and multidisciplinary actions necessary, from the beginning of last days situation, to the care after death. It is based on the Liverpool Care Pathway for the Dying Patient created by the Royal Liverpool University Hospital. The objective of the study is to evaluate the validity and effectiveness of the Cui-DAR CUDECA Plan in people in a situation of last days compared to conventional care in the assessment of symptoms and signs. The intervention group will be the patients in the last days of their illness treated at the Cudeca Center with the Cui-DAR Cudeca Plan and those of the control group those treated and deceased in the Palliative Care Unit of the Catalan Institute of Oncology of L'Hospitalet de Llobregat, located in the Duran i Reynals Hospital, which works together with the University Hospital of Bellvitge (Barcelona) and the patients treated in the Palliative Care Unit of San Juan de Dios Hospital in Pamplona (Navarra). In all groups, it will be assessed whether the quality standards recommended by the National Institute for Health and Care Excellence are met: "Care of dying adults in the last days of life", referring to the individualization of care, the anticipatory prescription of drugs and the control of hydration.
Null hypothesis (H0) that will be subjected to contrast in this study is that there are no differences in the assessment of symptoms and signs in patients in a situation of last days, regardless of whether the Cui-DAR CUDECA Plan is applied or not. Piloting will be done on a small sample of patients treated in Hospitalization Unit of CUDECA center.
For the sample calculation, results of national report on the care of people in a situation of imminent death in England have been taken into account.
Authorization of the Ethics Committee of the Costa del Sol District will be requested. The ethical principles established for research on human beings in the Declaration of Helsinki shall be maintained at all times.
Clinical data shall be kept segregated from identification data by means of an alphanumeric code. All registrations will be made respecting the precepts established in the current legislation on the protection of personal data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Acceptance to participate in the study by signing the informed consent.
- •Patients in the last days of life who die in Cudeca Foundation and who was cared under Cui-DAR Cudeca Plan during data collection period.
- •Patients in the last days of life who die in others Palliative care Units Cudeca Foundation and who was cared under Cui-DAR Cudeca Plan durging data collection period.
排除标准
- •No acceptance to participate in the study by signing the informed consent.
- •Patients in the last days of life who die in Cudeca Foundation and who wasn,t cared under Cui-DAR Cudeca Plan during data collection period.
研究组 & 干预措施
Patients who died in the Catalan Institute of Oncology hospital (Barcelona, Spain)
Patients in the last days of their illness who die treated in the Inpatient Unit of Catalan Institute of Oncology (L'Hospitalet de Llobregat ,Barcelona, España). No intervention.
Patients who died in the Inpatient Unit of San Juan de Dios Hospital (Pamplona, Navarra, Spain)
Patients in the last days of their illness who die treated in he Inpatient Unit of San Juan de Dios hospital (Pamplona, Navarra, Spain). No intervention.
Patients who died in the Hospitalization Unit of the Cudeca Foundation (Benalmádena, Málaga,Spain)
Patients in the last days of their illness who die treated in Cudeca,s Inpatient Unit attended with a specific care plan at this situation (Cui-DAR CUDECA Plan)
干预措施: Care Plan Cui-dar CUdeca (Other)
结局指标
主要结局
Number of patients with oncological and non-oncological diseases who are at the end of their lives and have been evaluated with the CUDECA Cui-DAR Plan for the care of symptoms and signs.
时间窗: Through study completion, an average of 12 months
Patients with oncological and non-oncological diseases who die in the Cudeca Foundation Hospitalisation Unit attended with the CUi-DAR Cudeca Plan.
次要结局
- Number of patients with oncological and non-oncological diseases who has individualised care plans in the last days of life.(Through study completion, an average of 3 months)
- Number of patients with oncological and non-oncological diseases who are at the end of their lives and have been given an advance prescription for medication.(Through study completion, an average of 3 months)
- Number of patients with oncological and non-oncological diseases with daily assessment of hydration at the end of life(Through study completion, an average of 3 months)
- Number of bereaved relatives of patients with cancer and non-cancer diseases who feel satisfied that the deceased person received support to drink or receive fluids if they so desired.(Through study completion, an average of 3 months)