Improving Pharmacological Transition of Palliative Care Patients From Inpatient to Outpatient Care (EntMedPall)

Improving Pharmacological Transition of Palliative Care Patients From Inpatient to Outpatient Care (Optimierung Der Pharmakologischen Überleitung Von Palliativpatient:Innen Von stationär Nach Ambulant)

The transition of palliative care patients from inpatient to outpatient care is aimed to be improved through structured pharmaceutical discharge management by a trained pharmacist. This data will be compared with retrospective cases.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cancer; COPD
• Intervention / Treatment: Other: Structured pharmaceutical discharge management

Detailed Description

As part of a prospective observational study with a retrospective comparison group, a pharmacist should, on request, check the discharge medication planned by the primary care physicians before discharge and discuss it with the various colleagues providing (follow-up) care. In addition, the availability in the outpatient "medicine cabinet" and the possibility of prescribing by the responsible GPs (by telephone) should be checked in advance. In addition, longitudinal focus groups with relevant stakeholders are to be conducted to collect quantitative data as well as qualitative data on the views of those providing and receiving treatment.

There will be cooperation with the Specialized Outpatient Palliative Care Service Muenster to ensure sufficient case numbers and a low rate of missing values through partial use of the standard care data from the "Information System Palliative Care" (ISPC) program they use.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoph Klaas, Dr. rer. nat.; Phone Number: +49 251 83-48843; Email: christoph.klaas@ukmuenster.de

Study Locations

• Germany
  • North Rhine-Westphalia
    • Muenster, North Rhine-Westphalia, Germany, 48149
      • Recruiting
      • University hospital Muenster
      • Contact: Philipp Lenz, Prof. Dr. med.; Phone Number: +49 (0)251 8353052; Email: philipp.lenz@ukmuenster.de
      • Principal Investigator: Christoph Klaas, Dr. rer. nat.
      • Sub-Investigator: Constanze Rémi, Dr. rer. biol. hum.
      • Sub-Investigator: Janina Krüger, Dr. med.
      • Sub-Investigator: Sofie May
      • Sub-Investigator: Florian Bernhardt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All individual indications for general and specialised palliative care as part of routine clinical practice (e.g.):

• advanced, malignant tumour disease
• advanced, chronic obstructive pulmonary disease
• Patients with advanced disease and limited life expectancy (approx. 12 months) Further care in the SOPC Muenster (prospective data) Sufficient understanding of the German language to be able to understand the information and consent form

Exclusion Criteria:

Impossibility of understanding the information and declaration of consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective patients; Current palliative care patients who are discharged from the University Hospital to outpatient palliative care.	Other: Structured pharmaceutical discharge management; These patients will receive structured pharmaceutical discharge management from inpatient to outpatient care.
No Intervention: Retrospective patients; Former palliative care patients who were discharged from the university hospital to outpatient palliative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(I) Drug-related problems	(I) Number of drug-related problems at the time of discharge according to PCNE (comparison of prospective, actually proposed changes vs. hypothetical number and type of problems at the time of discharge in the retrospective comparison cohort)	12 months
(II) Drug-related problems	(II) Type of drug-related problems at the time of discharge according to PCNE (comparison of prospective, actually proposed changes vs. hypothetical number and type of problems at the time of discharge in the retrospective comparison cohort)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of contacts	Number of contacts made by patients/relatives with SOPC within 7 days of discharge	12 months
Number of readmissions / visits	Number of readmissions and / or visits to the emergency department within 7 and 14 days after hospital discharge	12 months
(I) Medication changes	(I) Number of medication changes suggested by pharmacists according to PCNE	12 months
Adoption rate	Adoption rate by the primary care physicians of the pharmacist's proposed changes after PCNE (see primary endpoint)	12 months
(I) GP contact	(I) Contact made with GPs for medication planning	12 months
(I) SOPC contact	(I) Contact made with SOPC for medication planning and (II) resulting changes to discharge medication	12 months
(I) Post-discharge medication changes	Change in the number of medications in outpatient follow-up care	12 months
Focus groups	Satisfaction of inpatient physicians and those providing further treatment with forward-looking medication planning in 3 focus groups	12 months
(I) Further parameters	(I)Evaluation of further quantitative parameters from ISPC (SOPC)	12 months
(II) Medication changes	(II) Type of medication changes suggested by pharmacists according to PCNE	12 months
(II) GP contact	(II) Resulting changes to discharge medication following GP contact	12 months
(II) SOPC contact	(II) Resulting changes to discharge medication following SOPC contact	12 months
(II) Post-discharge medication changes	(II) Qualitative assessment of medication changes (classification of drug-related problems according to PCNE)	12 months
(II) Further parameters	(II) Evaluation of further quantitative parameters from the clinical information system (UKM)	12 months
Symptom burden	Change in patient symptom burden via Integrated Palliative Care Outcome. The total scores using the IPOS can range between 0 and 68 points. The higher the score, the more severe are the patient's symptoms. Scale after 3, 7 and 14 days compared to day 0 (discharge date)	12 months

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: University Hospital Munich
• Investigators: Study Chair: Christoph Klaas, Dr. rer. nat., Pharmacy of the University Hospital Muenster

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Palliative Care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2024-258-f-S; 2025-131-BO (Other Identifier: Ethikkommission an der Medizinischen Fakultät Bonn)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No