Palliative Outcome Evaluation Muenster I

NCT03286127 | Unknown

• 1 other identifier: UKM_POEM I
• Study Type: observational
• Target: 347
• Locations: 1 country
• Sites: 5

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.

Conditions

Cancer; Chronic Heart Failure; COPD Exacerbation; Palliative Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Generic health-related quality of life (EQ-5D-5L)

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

Study Arms (3)

PCU (unit)

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

Other: specialized palliative care

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

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

Interventions

specialized palliative care OTHER

specialized palliative care provided in different settings

IPCC (hospital); OPCC (outpatient); PCU (unit)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Indication for palliative care due to any advanced life-limiting and progressive disease
• years and older

You may not qualify if:

• Age under 18 years
• pregnant or breastfeeding women
• Inability to understand information for participation
• Refusal of participation

Sponsors & Collaborators

• University Hospital Muenster: lead
• St. Franziskus Hospital: collaborator
• Raphaelsklinik Münster: collaborator
• Josephs Hospital Warendorf: collaborator
• Palliativnetz Muenster gGmbH: collaborator

Study Sites (5)

Hospital St. Raphael Muenster

Münster, North Rhine-Westphalia, 48143, Germany

NOT YET RECRUITING

Hospital St. Franziskus Muenster

Münster, North Rhine-Westphalia, 48145, Germany

NOT YET RECRUITING

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Palliativnetz Muenster

Münster, North Rhine-Westphalia, 48161, Germany

RECRUITING

Hospital St. Josef Warendorf

Warendorf, North Rhine-Westphalia, 48231, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Philipp Lenz, PD Dr. med.

CONTACT

+49 (0)251 8353052; philipp.lenz@ukmuenster.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: September 11, 2017
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)