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NCT Number: NCT06648733

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location status: Recruiting

Location contact

Christoph Klaas, Dr. rer. nat.

PRINCIPAL_INVESTIGATOR

Constanze Rémi, Dr. rer. biol. hum.

SUB_INVESTIGATOR

Florian Bernhardt

SUB_INVESTIGATOR

Janina Krüger, Dr. med.

SUB_INVESTIGATOR

Philipp Lenz, Prof. Dr. med.

CONTACT

[email protected]

+49 (0)251 8353052

Sofie May

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured pharmaceutical discharge management

Other

These patients will receive structured pharmaceutical discharge management from inpatient to outpatient care.

Primary outcomes

  1. (I) Drug-related problems

    Time frame: 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)

  2. (II) Drug-related problems

    Time frame: 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 outcomes

  1. Number of contacts

    Time frame: 12 months

    Number of contacts made by patients/relatives with SOPC within 7 days of discharge

  2. Number of readmissions / visits

    Time frame: 12 months

    Number of readmissions and / or visits to the emergency department within 7 and 14 days after hospital discharge

  3. Symptom burden

    Time frame: 12 months

    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)

  4. (I) Medication changes

    Time frame: 12 months

    (I) Number of medication changes suggested by pharmacists according to PCNE

  5. Adoption rate

    Time frame: 12 months

    Adoption rate by the primary care physicians of the pharmacist's proposed changes after PCNE (see primary endpoint)

  6. (I) GP contact

    Time frame: 12 months

    (I) Contact made with GPs for medication planning

  7. (I) SOPC contact

    Time frame: 12 months

    (I) Contact made with SOPC for medication planning and (II) resulting changes to discharge medication

  8. (I) Post-discharge medication changes

    Time frame: 12 months

    Change in the number of medications in outpatient follow-up care

  9. Focus groups

    Time frame: 12 months

    Satisfaction of inpatient physicians and those providing further treatment with forward-looking medication planning in 3 focus groups

  10. (I) Further parameters

    Time frame: 12 months

    (I)Evaluation of further quantitative parameters from ISPC (SOPC)

  11. (II) Medication changes

    Time frame: 12 months

    (II) Type of medication changes suggested by pharmacists according to PCNE

  12. (II) GP contact

    Time frame: 12 months

    (II) Resulting changes to discharge medication following GP contact

  13. (II) SOPC contact

    Time frame: 12 months

    (II) Resulting changes to discharge medication following SOPC contact

  14. (II) Post-discharge medication changes

    Time frame: 12 months

    (II) Qualitative assessment of medication changes (classification of drug-related problems according to PCNE)

  15. (II) Further parameters

    Time frame: 12 months

    (II) Evaluation of further quantitative parameters from the clinical information system (UKM)

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph Klaas, Dr. rer. nat.

CONTACT

[email protected]

+49 251 83-48843

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • University Hospital Munich

Registry information

Official study title

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

Acronym: EntMedPall

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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