Adaptation and Validation of a Patient-centered Outcome Scale for People in the Intensive Care Unit (IPOS-ICU)

NCT07004920 | Not Yet Recruiting

• 1 other identifier: 2025-3146
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The focus of intensive care is on survival and the prolongation of life. The care of organ systems takes priority and is assessed through screening tools such as the Sequential Organ Failure Assessment (SOFA) score, which evaluates clinical and laboratory factors associated with prognosis. Despite advancements in modern intensive care, the hospital mortality rate for mechanically ventilated patients in 2022 was approximately 43%. Even for survivors of intensive care, post-intensive care syndrome poses a significant burden on quality of life. Although intensive care and palliative care often appear to be contradictory, clinical overlap between these populations is common, with both experiencing physical, psychosocial, and spiritual challenges that frequently require input from specialized teams. Nevertheless, palliative care remains underrepresented in German intensive care units (ICUs), with only 1.4% of ICU patients on prolonged mechanical ventilation receiving specialist palliative care. Therefore, the identification of patients in need of palliative care and the reduction of barriers such as limited resources and varying clinician attitudes must be addressed. This necessitates a robust tool for measuring and assessing palliative care needs specifically in ICU patients, enabling the implementation of interventions aimed at minimizing the burden on patients, families, and treating clinicians, as well as guiding appropriate allocation of healthcare resources. The Integrated Palliative Care Outcome Scale (IPOS) questionnaire was developed as a patient-centered measurement instrument from a palliative care perspective. IPOS enables the assessment of symptoms and needs from the viewpoint of patients and their families. For patients with COVID-19, an adapted version-IPOS-COV-was developed, wherein healthcare personnel assess patient symptoms and needs. However, no existing instrument comprehensively captures the physical, psychosocial, and spiritual needs of ICU patients and their families from a palliative care perspective. Such a tool could facilitate both the identification of patients requiring palliative care and serve as an endpoint for evaluating the effectiveness of palliative care interventions in ICU settings, including post-discharge outcomes related to post-intensive care syndrome affecting both patients and families. The underlying hypothesis is that a patient-centered measurement instrument addressing physical, psychosocial, and spiritual needs from a palliative care perspective for ICU patients can be developed and validated based on the IPOS. Additionally, demographic data, clinical course, ICU interventions (e.g., mechanical ventilation, dialysis, palliative care consultations, family discussions, and therapy goal limitations), as well as SOFA scores and Palliative Phase of Illness (PPoI) classifications at the time of IPOS-ICU assessment, will be collected. It is hypothesized that IPOS-ICU scores will correlate with disease severity (as measured by SOFA and PPoI) and poor ICU outcomes, including length of stay, mortality, and discharge location. Furthermore, it is hypothesized that interventions such as palliative care consultations will be associated with lower IPOS-ICU scores. In the first phase of the study, an international and multiprofessional expert panel with experience in both intensive and palliative care will adapt the IPOS questionnaire for ICU patients, resulting in the development of the IPOS-ICU. The following modification strategies will be applied: rewording, removal, addition of items, adjustment of recall periods, and inclusion of a "cannot assess" response option. Online meetings will be conducted with representatives from Germany, Switzerland, the United Kingdom, the Czech Republic, and the United States. A larger review team will then evaluate the adapted version, and an informal "comfort consultation" will be conducted in ICU settings to ensure that the IPOS-ICU is considered appropriate and acceptable by ICU staff. Following adaptation, the validation phase will be conducted using a multicenter design. After obtaining informed consent from study participants, the IPOS-ICU will be administered at designated time points identified during the adaptation process. ICU staff (including at least one nursing professional and one medical professional) will complete the IPOS-ICU. The questionnaire will include an assessment of the PPoI (categorized as stable, unstable, deteriorating, dying, or deceased), and a free-text field for recording the estimated number of hours spent with the patient. Electronic Case Report Forms will capture demographic data, SOFA scores, treatment details, and outcomes following ICU discharge, all extracted from medical records. This study holds significant relevance by addressing the gap between the identification of palliative care needs and the actual implementation and evaluation of palliative care in ICU settings.

Conditions

Intensive Care Unit Patients

Outcome Measures

Primary Outcomes (1)

• IPOS-ICU total score

  The primary outcome is the IPOS-ICU and its descriptive analysis. Each of the IPOS-ICU items will have the following units of measure: Not at all (0), Slightly (1), Moderately (2), Severely (3), Overwhelmingly (4), Cannot assess (e.g. unconscious). The investigators will calculate the total score of the IPOS-ICU at each time point of assessment.

  during the intervention

Secondary Outcomes (11)

• Number of positive IPOS-ICU items

  during the intervention

• Palliative Phase of Illness (PPoI)

  during the intervention

• SOFA score

  during the intervention

• Days of mechanical ventilation

  immediately after the intervention

• Days of ECMO

  immediately after the intervention

Interventions

IPOS-ICU OTHER

This is a prospective observational study. Health care providers will be asked to will out the IPOS-ICU for patients in the intensive care unit.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients aged above 18 years in the ICU will be screened for inclusion.

You may qualify if:

• Adult ICU patients
• written informed consent from patient or health-care proxy

You may not qualify if:

• age \< 18 years
• Language barrier (communication in German/local language or English not possible).
• ICU discharge 24h after admission
• no written consent

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• King's College London: collaborator
• Ludwig-Maximillians Universitat Munchen, Germany: collaborator

Study Sites (1)

University Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Central Study Contacts

Theresa Tenge, MD

CONTACT

+49 2118118451; theresa.tenge@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 4, 2025
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)