Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 5:54 PM
Study NCT ID:
NCT05842928
Status:
RECRUITING
Last Update Posted:
2025-05-04
First Post:
2023-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'To avoid selection bias and Hawthorne bias, the collaborating units (GP practice and community pharmacy) in the intervention group are blinded to the target drugs (PSA-PIM) until the time of randomisation, and in the control group until the end of the study. The same applies to patient participants.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 352}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-04-24', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points', 'timeFrame': '6 months', 'description': 'Clinically relevant reduction in PSA-PIM exposure at patient level after 6 months follow-up, as measured by the Drug Burden Index method. The primary endpoint is defined as a responder endpoint at patient level, where response is defined as a reduction in the Drug Burden Index (DBI) by ≥ 0.15 points (Primary endpoint: T2 vs T0)'}], 'secondaryOutcomes': [{'measure': 'Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points', 'timeFrame': '12 months', 'description': 'Clinically relevant reduction in PSA-PIM exposure at patient level after 12 months follow-up, as measured by the Drug Burden Index method (T4 vs T0)'}, {'measure': 'Frequency of deprescribing PSA-PIM stratified by PSA-PIM subgroups', 'timeFrame': '12 months', 'description': 'Proportion (%) of patients with a reduction in DBI ≥ 0.15 (T2 vs T0; T4 vs T0)'}, {'measure': 'Total exposure with PSA-PIM', 'timeFrame': '12 months', 'description': 'Average of the Drug Burden Index (DBI); mean change in the number of PSA-PIM taken (T2 vs T0; T4 vs T0)'}, {'measure': 'Total exposure to PSA-PIM stratified by PSA-PIM subgroups', 'timeFrame': '12 months', 'description': 'Average of the Drug Burden Index (DBI); mean change in the number of PSA-PIM taken (T2 vs T0; T4 vs T0)'}, {'measure': 'Frequency of new PSA-PIM prescriptions', 'timeFrame': '12 months', 'description': 'Proportion (%) of patients with a new prescription of ≥1 PSA-PIM (T2 vs T0; T4 vs T0)'}, {'measure': 'Frequency of taking other potentially inappropriate medication (PIM) (Validated PIM lists, e.g. PRISCUS list, START/STOPP, Anticholinergic Burden)', 'timeFrame': '12 months', 'description': 'Average change in the number of PIMs (T2 vs T0; T4 vs T0)'}, {'measure': 'Number of falls and hospitalisations due to fall events (Falls diary, Hospitalisation diary according to FIMA)', 'timeFrame': '12 months', 'description': 'Proportion (%) of patients with falls/hospitalisations due to fall injuries (T2 vs T0; T4 vs T0)'}, {'measure': 'Cognition (Verbal Fluency Test)', 'timeFrame': '12 months', 'description': 'Average (T2 vs T0; T4 vs T0)'}, {'measure': 'Quality of life (EQ5-D-5L)', 'timeFrame': '12 months', 'description': 'Average (T2 vs T0; T4 vs T0)'}, {'measure': 'Insomnia (Regensburg Insomnia Scale; RIS)', 'timeFrame': '12 months', 'description': 'Change from baseline in psychological symptoms and sleep assessed with the Regensburg Insomnia Scale (RIS). RIS includes 10 questions on cognitive, emotional and psychophysiological aspects of a sleep disorder. Five answer options for each question are possible (scored 0 to 4; higher scores indicate higher burden). The overall RIS score is the sum of the scores from each of the 10 questions. The overall RIS score can therefore range from zero to 40.\n\nAverage (T2 vs T0; T4 vs T0)'}, {'measure': 'Adverse drug reactions (ADRs)', 'timeFrame': '12 months', 'description': 'Average (T2 vs T0; T4 vs T0)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polypharmacy', 'General Practice', 'Primary Health Care', 'Pharmacies', 'Medication Safety'], 'conditions': ['Deprescriptions', 'Antidepressive Agents', 'Antipsychotic Agents', 'Analgesics, Opioid', 'Hypnotics and Sedatives', 'Cholinergic Antagonists']}, 'descriptionModule': {'briefSummary': 'The PARTNER study is a multicentre, two-arm, pragmatic cluster-randomised trial evaluating the impact of a focused and patient-centred cooperation between general practitioners (GPs) and community pharmacists (PARTNER intervention) on reductions in the use of psychotropic, sedative and anticholinergic potentially inappropriate medication (PSA-PIM) compared to a control intervention. The PARTNER intervention comprises (1) education for health care professionals, (2) an interprofessional workshop and case conference, (3) a pharmacy visit with brown bag/medication review and patient empowerment, (4) GP practice visit with shared decision making. The control intervention only comprises a pharmacy visit with brown bag review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 65 years or older\n* Patient is capable of giving consent\n* GP contact in the quarter prior to inclusion\n* Current use of ≥ 5 drugs, including ≥ 1 PSA-PIM (hypnotics, opioids, gabapentinoids, antipsychotics, antidepressants, anticholinergic urospasmolytics) with a treatment duration of ≥ 6 months\n* Willingness to select a regular pharmacy for the study period\n* Consent to data exchange between GP and community pharmacy\n\nExclusion Criteria:\n\n* Terminal illness (life expectancy \\< 6 months)\n* Current treatment of pain associated with cancer\n* Other serious physical illness or mental distress (e.g. bereavement) that makes participation in the study impossible (according to the GP's assessment)\n* Psychiatric illness or addiction that makes participation in the study impossible (according to the GP's assessment)\n* Unable to meet the requirements of the study (participation in telephone or written questionnaires, visits to the GP practice or community pharmacy, alone or with the help of caregivers for physical infirmity)\n* Current participation in research projects on medication safety or geriatric medicine"}, 'identificationModule': {'nctId': 'NCT05842928', 'acronym': 'PARTNER', 'briefTitle': 'Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy: a Cluster-randomised Trial', 'orgStudyIdInfo': {'id': '01VSF21038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Intensified and patient-centred cooperation between GPs and pharmacists including patient empowerment', 'interventionNames': ['Behavioral: PARTNER intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'Extended routine care', 'interventionNames': ['Behavioral: Control intervention']}], 'interventions': [{'name': 'PARTNER intervention', 'type': 'BEHAVIORAL', 'description': 'The PARTNER intervention includes the following components:\n\n1. Education for health care professionals\n\n A) written manual on deprescribing PSA-PIM, which consists of brief information and more detailed explanations;\n\n B) access to digital instructional videos/podcasts that address potential problems in deprescribing and provide possible solutions;\n\n C) checklist for identification of drug-related problems for pharmacists;\n\n D) tapering support tool to facilitate the selection of tapering schemes;\n\n E) divisibility list for PSA-PIM to support the implementation of tapering schemes;\n\n F) empowerment brochures for patients each focussing on one PSA-PIM subgroup\n2. Interprofessional workshop and case conference for GPs and pharmacists\n3. Pharmacy visit (brown bag/medication review) including patient empowerment\n4. GP practice visit including shared decision making (SDM)', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Control intervention', 'type': 'BEHAVIORAL', 'description': 'The control intervention only comprises a pharmacy visit with brown bag review.', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33615', 'city': 'Bielefeld', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christiane Muth, Prof. Dr.', 'role': 'CONTACT', 'email': 'christiane.muth@uni-bielefeld.de', 'phone': '+49 521 106-67982'}, {'name': 'Svetlana Puzhko', 'role': 'CONTACT', 'email': 'svetlana.puzhko@uni-bielefeld.de', 'phone': '+49 521 106-86689'}], 'facility': 'University of Bielefeld', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '80336', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tobias Dreischulte, Prof. Dr.', 'role': 'CONTACT', 'email': 'tobias.dreischulte@med.uni-muenchen.de', 'phone': '+49 89 4400 55447'}, {'name': 'Annette Haerdtlein', 'role': 'CONTACT', 'email': 'annette.haerdtlein@med.uni-muenchen.de', 'phone': '+49 89 4400 54976'}], 'facility': 'University Hospital, LMU Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '58448', 'city': 'Witten', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Achim Mortsiefer, Prof. Dr.', 'role': 'CONTACT', 'email': 'achim.mortsiefer@uni-wh.de', 'phone': '+49 2302 926-7609'}, {'name': 'Sophie Peter', 'role': 'CONTACT', 'email': 'sophie.peter@uni-wh.de', 'phone': '+49 2302 926-735'}], 'facility': 'Witten/Herdecke University', 'geoPoint': {'lat': 51.44362, 'lon': 7.35258}}], 'centralContacts': [{'name': 'Tobias Dreischulte, Prof. Dr.', 'role': 'CONTACT', 'email': 'tobias.dreischulte@med.uni-muenchen.de', 'phone': '+49 89 4400 55447'}, {'name': 'Annette Haerdtlein', 'role': 'CONTACT', 'email': 'annette.haerdtlein@med.uni-muenchen.de', 'phone': '+49 89 4400 54976'}], 'overallOfficials': [{'name': 'Tobias Dreischulte, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bielefeld University', 'class': 'OTHER'}, {'name': 'University of Witten/Herdecke', 'class': 'OTHER'}, {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, {'name': 'University Hospital Regensburg', 'class': 'OTHER'}, {'name': 'Institute for Applied Quality Improvement and Research in Health Care', 'class': 'UNKNOWN'}, {'name': 'Techniker Krankenkasse', 'class': 'OTHER'}, {'name': 'Federal Joint Committee', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Health Services Research', 'investigatorFullName': 'Tobias Dreischulte', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}