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Clinical Trials/NCT03286127
NCT03286127
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Assessment of Palliative Care in Inpatient and Outpatient Settings Using the Integrated Palliative Care Outcome Scale: a Multi-centric Observational Study

University Hospital Muenster5 sites in 1 country347 target enrollmentSeptember 11, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
University Hospital Muenster
Enrollment
347
Locations
5
Primary Endpoint
symptom burden (IPOS)
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 11, 2017
End Date
December 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Muenster
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

symptom burden (IPOS)

Time Frame: From Baseline to End of Follow-Up (0, 1 week)

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.

Secondary Outcomes

  • Generic health-related quality of life (EQ-5D-5L)(From Baseline to End of Follow-Up (0, 1 week))

Study Sites (5)

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