- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07446673
Evaluation of CUDECA Cui-DAR Plan in People With Oncological and Non-oncological Diseases in the Last Days of Their Lives (CUIDARCUDECA) (CUIDARCUDECA)
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)
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Barcelona
-
Barcelona, Barcelona, Spain
- Instituto Catalán de Oncología
-
-
Málaga
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Benalmádena, Málaga, Spain, 29631
- Fundación CUDECA
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Navarre
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Pamplona, Navarre, Spain
- Hospital San Juan de Dios
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Pacients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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)
|
Attend to the patient in the last days of their life with the CUi-DAR care plan
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 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.
|
Through study completion, an average of 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with oncological and non-oncological diseases who has individualised care plans in the last days of life.
Time Frame: Through study completion, an average of 3 months
|
Number of patients with oncological and non-oncological diseases whose medical records indicate that they are in their final days, whose signs and symptoms are assessed, and who have an updated care plan that has been discussed with the patient and their family.
|
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.
Time Frame: Through study completion, an average of 3 months
|
Number of patients with oncological and non-oncological diseases whose medical records indicate that they have been assessed for their prescription needs for symptoms that may arise in the final days of life and for anticipatory medications with individualised indications for use, dosage, and route of administration.
|
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
Time Frame: Through study completion, an average of 3 months
|
Number of patients with oncological and non-oncological diseases whose medical records indicate that their hydration status has been assessed daily during the last days of life, and who have had discussions about the risks and benefits of hydration options.
|
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.
Time Frame: Through study completion, an average of 3 months
|
Number of bereaved relatives of patients with oncological and non-oncological diseases whose medical records indicate that deceased person received support to drink or receive fluids if they so desired.
|
Through study completion, an average of 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: Baseline
|
Age of participant measured in years
|
Baseline
|
|
Sex
Time Frame: Baseline
|
Sex of the participant
|
Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CUDECA FOUNDATION
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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