NCT07387224

Brief Summary

Patients with advanced chronic diseases often have complex health needs and may benefit from palliative care. However, many of these patients are not identified early enough to receive appropriate palliative care interventions. This prospective observational study aims to identify hospitalized patients and patients attending a day hospital with advanced chronic conditions who have palliative care needs, using the NECPAL tool. NECPAL is a validated screening instrument designed to identify patients with advanced chronic diseases who may benefit from palliative care, based on clinical indicators, disease progression, functional decline, and health care utilization. Adult patients with advanced oncological and non-oncological chronic diseases will be consecutively evaluated. The NECPAL tool will be applied by trained investigators as part of routine clinical assessment. Patients will be classified as NECPAL positive or NECPAL negative according to predefined criteria. The study will estimate the proportion of patients identified as NECPAL positive, describe their clinical characteristics, and analyze whether they are receiving palliative care. Secondary objectives include comparing clinical variables, comorbidity indices, and mortality between NECPAL-positive and NECPAL-negative patients over follow-up. The results of this study will provide information on the prevalence of palliative care needs among patients with advanced chronic diseases and support early identification strategies in hospital settings.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Feb 2024Feb 2028

Study Start

First participant enrolled

February 1, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

June 10, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

January 28, 2026

Last Update Submit

June 6, 2026

Conditions

Keywords

NECPAL toolPalliative Care NeedsAdvanced Chronic ConditionsEarly IdentificationScreening ToolObservational StudyPrediction

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients Identified as NECPAL Positive

    Proportion of adult patients with advanced oncological and non-oncological chronic diseases who are identified as NECPAL positive using the NECPAL screening tool during hospital admission or day hospital assessment.

    At baseline (at the time of inclusion)

Study Arms (1)

Observational Cohort

Adult patients with advanced oncological and non-oncological chronic diseases hospitalized for an acute medical condition or attending a day hospital, assessed using the NECPAL screening tool as part of routine clinical care. No experimental intervention is assigned.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients with advanced oncological and non-oncological chronic diseases who are hospitalized for an acute medical condition or evaluated in a day hospital setting. Patients are consecutively assessed as part of routine clinical care and screened for palliative care needs using the NECPAL tool.

You may qualify if:

  • Adults aged 18 years or older.
  • Hospitalized patients admitted for an acute medical condition or patients attending a day hospital.
  • Presence of at least one advanced chronic oncological or non-oncological disease.
  • Ability to provide informed consent or availability of a legally authorized representative to provide consent.

You may not qualify if:

  • Patients in the last days of life at the time of assessment.
  • Patients who die during the acute hospitalization process.
  • Patients with end-stage organ failure who are listed for organ transplantation.
  • Patients with severe psychiatric disease that interferes with study participation.
  • Patients previously included in the study during a prior hospital admission.
  • Patients for whom outpatient follow-up cannot be ensured.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Infanta Leonor

Madrid, Madrid, 28023, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Madrid, 28030, Spain

Location

MeSH Terms

Conditions

NeoplasmsRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
38 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 4, 2026

Study Start

February 1, 2024

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

June 10, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the observational nature of the study and the inclusion of sensitive clinical data collected from routine care. Data sharing would require additional ethical approvals and data-sharing agreements that are not currently planned.

Locations