Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 1:43 AM
Study NCT ID:
NCT06648733
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2024-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Pharmacological Transition of Palliative Care Patients From Inpatient to Outpatient Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(I) Drug-related problems', 'timeFrame': '12 months', 'description': '(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)'}, {'measure': '(II) Drug-related problems', 'timeFrame': '12 months', 'description': '(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)'}], 'secondaryOutcomes': [{'measure': 'Number of contacts', 'timeFrame': '12 months', 'description': 'Number of contacts made by patients/relatives with SOPC within 7 days of discharge'}, {'measure': 'Number of readmissions / visits', 'timeFrame': '12 months', 'description': 'Number of readmissions and / or visits to the emergency department within 7 and 14 days after hospital discharge'}, {'measure': 'Symptom burden', 'timeFrame': '12 months', 'description': "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)"}, {'measure': '(I) Medication changes', 'timeFrame': '12 months', 'description': '(I) Number of medication changes suggested by pharmacists according to PCNE'}, {'measure': 'Adoption rate', 'timeFrame': '12 months', 'description': "Adoption rate by the primary care physicians of the pharmacist's proposed changes after PCNE (see primary endpoint)"}, {'measure': '(I) GP contact', 'timeFrame': '12 months', 'description': '(I) Contact made with GPs for medication planning'}, {'measure': '(I) SOPC contact', 'timeFrame': '12 months', 'description': '(I) Contact made with SOPC for medication planning and (II) resulting changes to discharge medication'}, {'measure': '(I) Post-discharge medication changes', 'timeFrame': '12 months', 'description': 'Change in the number of medications in outpatient follow-up care'}, {'measure': 'Focus groups', 'timeFrame': '12 months', 'description': 'Satisfaction of inpatient physicians and those providing further treatment with forward-looking medication planning in 3 focus groups'}, {'measure': '(I) Further parameters', 'timeFrame': '12 months', 'description': '(I)Evaluation of further quantitative parameters from ISPC (SOPC)'}, {'measure': '(II) Medication changes', 'timeFrame': '12 months', 'description': '(II) Type of medication changes suggested by pharmacists according to PCNE'}, {'measure': '(II) GP contact', 'timeFrame': '12 months', 'description': '(II) Resulting changes to discharge medication following GP contact'}, {'measure': '(II) SOPC contact', 'timeFrame': '12 months', 'description': '(II) Resulting changes to discharge medication following SOPC contact'}, {'measure': '(II) Post-discharge medication changes', 'timeFrame': '12 months', 'description': '(II) Qualitative assessment of medication changes (classification of drug-related problems according to PCNE)'}, {'measure': '(II) Further parameters', 'timeFrame': '12 months', 'description': '(II) Evaluation of further quantitative parameters from the clinical information system (UKM)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palliative Care'], 'conditions': ['Cancer', 'Heart Failure', 'COPD']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThere 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll individual indications for general and specialised palliative care as part of routine clinical practice (e.g.):\n\n* advanced, malignant tumour disease\n* advanced, chronic obstructive pulmonary disease\n* 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\n\nExclusion Criteria:\n\nImpossibility of understanding the information and declaration of consent.'}, 'identificationModule': {'nctId': 'NCT06648733', 'acronym': 'EntMedPall', 'briefTitle': 'Improving Pharmacological Transition of Palliative Care Patients From Inpatient to Outpatient Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Improving Pharmacological Transition of Palliative Care Patients From Inpatient to Outpatient Care (Optimierung Der Pharmakologischen Überleitung Von Palliativpatient:Innen Von stationär Nach Ambulant)', 'orgStudyIdInfo': {'id': '2024-258-f-S'}, 'secondaryIdInfos': [{'id': '2025-131-BO', 'type': 'OTHER', 'domain': 'Ethikkommission an der Medizinischen Fakultät Bonn'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospective patients', 'description': 'Current palliative care patients who are discharged from the University Hospital to outpatient palliative care.', 'interventionNames': ['Other: Structured pharmaceutical discharge management']}, {'type': 'NO_INTERVENTION', 'label': 'Retrospective patients', 'description': 'Former palliative care patients who were discharged from the university hospital to outpatient palliative care.'}], 'interventions': [{'name': 'Structured pharmaceutical discharge management', 'type': 'OTHER', 'description': 'These patients will receive structured pharmaceutical discharge management from inpatient to outpatient care.', 'armGroupLabels': ['Prospective patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philipp Lenz, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'philipp.lenz@ukmuenster.de', 'phone': '+49 (0)251 8353052'}, {'name': 'Christoph Klaas, Dr. rer. nat.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Constanze Rémi, Dr. rer. biol. hum.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Janina Krüger, Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sofie May', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Florian Bernhardt', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'centralContacts': [{'name': 'Christoph Klaas, Dr. rer. nat.', 'role': 'CONTACT', 'email': 'christoph.klaas@ukmuenster.de', 'phone': '+49 251 83-48843'}], 'overallOfficials': [{'name': 'Christoph Klaas, Dr. rer. nat.', 'role': 'STUDY_CHAIR', 'affiliation': 'Pharmacy of the University Hospital Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}