Clinical trial NCT07004920: Adaptation and Validation of a Patient-centered Outcome Scale for People in the Intensive Care Unit (IPOS-ICU)
Official title: Adaptation and Validation of a Patient-centered Outcome Scale for People in the Intensive Care Unit (IPOS-ICU)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intensive Care Unit Patients
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: King's College London
name: Ludwig-Maximillians Universitat Munchen, Germany
First posted: 2025-06-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients aged above 18 years in the ICU will be screened for inclusion.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: IPOS-ICU total score
timeFrame: during the intervention
Secondary outcomes:
measure: Number of positive IPOS-ICU items
timeFrame: during the intervention
measure: Palliative Phase of Illness (PPoI)
timeFrame: during the intervention
measure: SOFA score
timeFrame: during the intervention
measure: Days of mechanical ventilation
timeFrame: immediately after the intervention
measure: Days of ECMO
timeFrame: immediately after the intervention
measure: Days of dialysis
timeFrame: immediately after the intervention
measure: ICU length of stay
timeFrame: immediately after the intervention
measure: ICU mortality
timeFrame: immediately after the intervention
measure: ICU discharge location
timeFrame: immediately after the intervention
measure: Functional status at ICU discharge
timeFrame: immediately after the intervention
measure: Clinical Frailty Scale (CFS) at ICU discharge
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University Hospital Düsseldorf
state: NRW
Study officials:
References: