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NCT Number: NCT07387224

Identification of Patients With Advanced Chronic Diseases in Need of Palliative Care

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.

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This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of Patients Identified as NECPAL Positive

    Time frame: At baseline (at the time of inclusion)

    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.

Sponsors and collaborators

Lead sponsor

Infanta Leonor University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: NECPAL_HUIL

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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