Palliative Outcome Evaluation Muenster I

Cancer Clinical Trial

— POEM I  

Official title:

Assessment of Palliative Care in Inpatient and Outpatient Settings Using the Integrated Palliative Care Outcome Scale: a Multi-centric Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03286127
• Other study ID #: UKM_POEM I
• Status: Recruiting
• Start date: September 11, 2017
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: University Hospital Muenster
• Contact: Philipp Lenz, PD Dr. med.
• Phone: +49 (0)251 8353052
• Email: philipp.lenz[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 347
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chronic Heart Failure
• COPD Exacerbation
• Heart Failure
• Palliative Care

Intervention

Other:
• specialized palliative care
specialized palliative care provided in different settings

Locations

Country	Name	City	State
Germany	Hospital St. Franziskus Muenster	Muenster	North Rhine-Westphalia
Germany	Hospital St. Raphael Muenster	Muenster	North Rhine-Westphalia
Germany	Palliativnetz Muenster	Muenster	North Rhine-Westphalia
Germany	University Hospital Muenster	Muenster	North Rhine-Westphalia
Germany	Hospital St. Josef Warendorf	Warendorf	North Rhine-Westphalia

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital Muenster	Josephs Hospital Warendorf, Palliativnetz Muenster gGmbH, Raphaelsklinik Münster, St. Franziskus Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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).	From Baseline to End of Follow-Up (0, 1 week)