Identification of Patients With Advanced Chronic Diseases in Need of Palliative Care (NECPAL_HUIL)

Study to Identify Patients With Advanced Chronic Conditions in Need of Palliative Care: Validation of the NECPAL Instrument.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Disease; Palliative Care; Multimorbidity; Mortality Prediction; Advanced Chronic Disease

Detailed Description

This is a prospective, observational, analytical study designed to identify patients with advanced chronic conditions who have palliative care needs, using the NECPAL screening tool.

The study will be conducted in hospitalized patients admitted for an acute medical condition and in patients attending a day hospital. Adult patients with at least one advanced chronic oncological or non-oncological disease will be consecutively assessed during routine clinical care.

The NECPAL tool will be applied by trained investigators following the standardized methodology recommended by its developers. The assessment begins with the Surprise Question ("Would you be surprised if this patient died within the next 12 months?"). If the answer is negative, additional clinical indicators related to disease severity, functional decline, comorbidity, symptom burden, and health care utilization are evaluated. Patients will be classified as NECPAL positive or NECPAL negative according to predefined criteria.

For patients identified as NECPAL positive, information regarding current palliative care involvement will be recorded. Clinical, functional, social, and health care utilization variables will be collected from the electronic medical record as part of routine clinical documentation.

Secondary analyses will compare NECPAL-positive and NECPAL-negative patients in terms of comorbidity, functional status, and mortality. Mortality will be assessed during follow-up using hospital records and, when necessary, telephone contact.

The study aims to describe the prevalence of palliative care needs in patients with advanced chronic diseases, evaluate the alignment between identified needs and current palliative care provision, and support early identification of patients who may benefit from palliative care in hospital settings.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28023
      • Hospital Universitario Infanta Leonor
    • Madrid, Madrid, Spain, 28030
      • Hospital Universitario Infanta Leonor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Infanta Leonor University Hospital
• Collaborators: Fundación para la Investigación e Innovación Biomédica (FIIB) del Hospital Universitario Infanta Leonor y Hospital Universitario del Sureste

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Observational Study; Prediction; Early Identification; Screening Tool; NECPAL tool; Palliative Care Needs; Advanced Chronic Conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Chronic Disease
• Other Study ID Numbers: NECPAL_HU-Infanta Leonor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No