Improving Pharmacological Transition of Palliative Care Patients From Inpatient to Outpatient Care

Not Applicable

Recruiting

• Conditions: Cancer; Heart Failure; COPD

• Registration Number: NCT06648733
• Lead Sponsor: University Hospital Muenster

Brief Summary

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.

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 Timeline

• Study Start: 2024-06-20
• Study First Submitted: 2024-06-27
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Study First Posted: 2024-10-18
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
(I) Drug-related problems	12 months	(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)
(II) Drug-related problems	12 months	(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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Muenster; 🇩🇪 Muenster, North Rhine-Westphalia, Germany