Clinical trial NCT03286127: Palliative Outcome Evaluation Muenster I
Official title: Assessment of Palliative Care in Inpatient and Outpatient Settings Using the Integrated Palliative Care Outcome Scale: a Multi-centric Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Chronic Heart Failure
COPD Exacerbation
Palliative Care
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: St. Franziskus Hospital
name: Raphaelsklinik Münster
name: Josephs Hospital Warendorf
name: Palliativnetz Muenster gGmbH
First posted: 2017-09-18
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with an advanced life-limiting and progressive disease needing palliative care. The three groups are formed depending of the setting in which palliative care will be provided.

Brief summary: For patients with an advanced disease and their families an excellent and compassionate care is essential. However, in hospitals optimal end-of-life care is not yet fully realized and patient's needs are often not met. Palliative care is able to increase patients' quality of life and to carefully meet their and their families' needs.

To improve the awareness of unmet needs patient-reported outcome measurement has been the pivot of latest palliative care research. Besides the improvement of care outcome measurement allows the evaluation of the quality of palliative care and comparisons on a national and international level.

The aim of the present study is to evaluate the quality of palliative care in different settings (palliative care unit, inpatient and outpatient consultation teams) using the Integrated Palliative Care Outcome Scale (IPOS). The IPOS has been lately developed as improved follow-up version of the Palliative Care Outcome Scale (POS) integrating most important questions and simultaneously being brief and comprehensive. The study is planned as a multi-centric observational study. Primary endpoint is the reduction of symptom burden of patients.

The clinical study hypothesis bases on the assumption that palliative care can change the symptom burden, measured by a change in the IPOS overall profile score, and that there might be a difference in the size of the effect depending on the caring setting.

Detailed description: After the enrolment and consent of participation the patient receive a questionnaire consisting of three independent assessments: To assess the symptom burden and specific palliative care needs the Integrated Palliative Outcome Scale (IPOS) is used. To measure the generic health-related quality of life the patient has to answer the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). To get an opinion of the general condition the patient is to complete the NCCN Distress Thermometer which includes a visual analogue scale (with values from 0 to 10).

Meanwhile, a professional palliative caregiver completes a questionnaire about the main demographic aspects of the patients and assess the palliative care needs and the symptom burden using the IPOS.

After one week both, patient and professional palliative caregiver, will receive the same questionnaires again to assess the change from baseline.

Eligibility criteria: Inclusion Criteria:

* Indication for palliative care due to any advanced life-limiting and progressive disease
* 18 years and older

Exclusion Criteria:

* Age under 18 years
* pregnant or breastfeeding women
* Inability to understand information for participation
* Refusal of participation

Primary outcomes:
measure: symptom burden (IPOS)
timeFrame: From Baseline to End of Follow-Up (0, 1 week)
Secondary outcomes:
measure: Generic health-related quality of life (EQ-5D-5L)
timeFrame: From Baseline to End of Follow-Up (0, 1 week)
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Hospital St. Raphael Muenster
state: North Rhine-Westphalia
city: Muenster
country: Germany
facility: Hospital St. Franziskus Muenster
state: North Rhine-Westphalia
city: Muenster
country: Germany
facility: University Hospital Muenster
state: North Rhine-Westphalia
city: Muenster
country: Germany
facility: Palliativnetz Muenster
state: North Rhine-Westphalia
city: Warendorf
country: Germany
facility: Hospital St. Josef Warendorf
state: North Rhine-Westphalia
Study officials:
References: