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| Name | Class |
|---|---|
| St. Franziskus Hospital | OTHER |
| Raphaelsklinik Münster | UNKNOWN |
| Josephs Hospital Warendorf | UNKNOWN |
| Palliativnetz Muenster gGmbH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCU (unit) | Those patients who received specialised palliative care on a palliative care unit.(palliative care unit) |
| |
| IPCC (hospital) | Those patients admitted to a regular hospital ward who received specialised palliative care from an inpatient palliative care consultation team. (inpatient palliative care consultation team) |
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| OPCC (outpatient) | Those patients who received specialised palliative care at home from an outpatient palliative care consultation team. (outpatient palliative care consultation team) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| specialized palliative care | Other | specialized palliative care provided in different settings |
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| Measure | Description | Time Frame |
|---|---|---|
| symptom burden (IPOS) | Change from baseline in palliative care needs and specific symptoms (at day 7) assessed with the Integrated Palliative Care Outcome Scale (IPOS). The IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support. The overall profile score is the sum of the scores from each of the 17 questions. | From Baseline to End of Follow-Up (0, 1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Generic health-related quality of life (EQ-5D-5L) | Change from baseline in patients' generic health-related quality of life measured with the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale of the EQ-5D-5L questionnaire ranges from 0 to 100 (with 0 representing the worst health the patient can imagine and 100 representing the best health the patient can imagine). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philipp Lenz, PD Dr. med. | Contact | +49 (0)251 8353052 | philipp.lenz@ukmuenster.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital St. Raphael Muenster | Not yet recruiting | Münster | North Rhine-Westphalia | 48143 | Germany |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| UNKNOWN |
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| From Baseline to End of Follow-Up (0, 1 week) |
| Hospital St. Franziskus Muenster | Not yet recruiting | Münster | North Rhine-Westphalia | 48145 | Germany |
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| University Hospital Muenster | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
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| Palliativnetz Muenster | Recruiting | Münster | North Rhine-Westphalia | 48161 | Germany |
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| Hospital St. Josef Warendorf | Not yet recruiting | Warendorf | North Rhine-Westphalia | 48231 | Germany |
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