Palliative Outcome Evaluation Muenster I (POEM I)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Chronic Heart Failure; Palliative Care; COPD Exacerbation
• Intervention / Treatment: Other: specialized palliative care

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.

• Study Type: Observational
• Enrollment (Anticipated): 347

Contacts and Locations

• Study Contact: Name: Philipp Lenz, PD Dr. med.; Phone Number: +49 (0)251 8353052; Email: philipp.lenz@ukmuenster.de

Study Locations

• Germany
  • North Rhine-Westphalia
    • Muenster, North Rhine-Westphalia, Germany, 48143
      • Not yet recruiting
      • Hospital St. Raphael Muenster
      • Contact: Marc Theisen, Dr. med.; Phone Number: +49 (0)251 5007 4118; Email: m.theisen@alexianer.de
    • Muenster, North Rhine-Westphalia, Germany, 48145
      • Not yet recruiting
      • Hospital St. Franziskus Muenster
      • Contact: Anne Bremer, Dr. med.; Phone Number: +49 (0)251 935 5564; Email: onkologie@sfh-muenster.de
    • Muenster, North Rhine-Westphalia, Germany, 48149
      • Recruiting
      • University Hospital Muenster
      • Contact: Philipp Lenz, PD Dr. med.; Phone Number: +49 (0)251 8353052; Email: philipp.lenz@ukmuenster.de
    • Muenster, North Rhine-Westphalia, Germany, 48161
      • Recruiting
      • Palliativnetz Muenster
      • Contact: Ulrike Hofmeister, Dr. med.; Phone Number: +49 (0)251 1625662; Email: info@palliativnetz-muenster.de
    • Warendorf, North Rhine-Westphalia, Germany, 48231
      • Not yet recruiting
      • Hospital St. Josef Warendorf
      • Contact: Dirk Domagk, Prof. Dr. med.; Phone Number: +49 (0)2581 20 1752; Email: palliativstation@jhwaf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PCU (unit); Those patients who received specialised palliative care on a palliative care unit.(palliative care unit)	Other: specialized palliative care; specialized palliative care provided in different settings
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)	Other: specialized palliative care; specialized palliative care provided in different settings
OPCC (outpatient); Those patients who received specialised palliative care at home from an outpatient palliative care consultation team. (outpatient palliative care consultation team)	Other: specialized palliative care; specialized palliative care provided in different settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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).	From Baseline to End of Follow-Up (0, 1 week)

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: St. Franziskus Hospital; Raphaelsklinik Münster; Josephs Hospital Warendorf; Palliativnetz Muenster gGmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: UKM_POEM I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No