Palliative Outcome Evaluation Muenster I

NCT ID: NCT03286127

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-11

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Chronic Heart Failure COPD Exacerbation Palliative Care

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PCU (unit)

Those patients who received specialised palliative care on a palliative care unit.(palliative care unit)

specialized palliative care

Intervention Type OTHER

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)

specialized palliative care

Intervention Type OTHER

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)

specialized palliative care

Intervention Type OTHER

specialized palliative care provided in different settings

Interventions

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specialized palliative care

specialized palliative care provided in different settings

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Franziskus Hospital

OTHER

Sponsor Role collaborator

Raphaelsklinik Münster

UNKNOWN

Sponsor Role collaborator

Josephs Hospital Warendorf

UNKNOWN

Sponsor Role collaborator

Palliativnetz Muenster gGmbH

UNKNOWN

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital St. Raphael Muenster

Münster, North Rhine-Westphalia, Germany

Site Status NOT_YET_RECRUITING

Hospital St. Franziskus Muenster

Münster, North Rhine-Westphalia, Germany

Site Status NOT_YET_RECRUITING

University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

Palliativnetz Muenster

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

Hospital St. Josef Warendorf

Warendorf, North Rhine-Westphalia, Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Philipp Lenz, PD Dr. med.

Role: CONTACT

+49 (0)251 8353052

Facility Contacts

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Marc Theisen, Dr. med.

Role: primary

+49 (0)251 5007 4118

Anne Bremer, Dr. med.

Role: primary

+49 (0)251 935 5564

Philipp Lenz, PD Dr. med.

Role: primary

+49 (0)251 8353052

Ulrike Hofmeister, Dr. med.

Role: primary

+49 (0)251 1625662

Dirk Domagk, Prof. Dr. med.

Role: primary

+49 (0)2581 20 1752

Other Identifiers

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UKM_POEM I

Identifier Type: -

Identifier Source: org_study_id

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