Patient-centred Deprescribing of Psychotropic, Sedative a... | NCT05842928

NCT05842928

Status Module

Sponsor/Collaborators Module

Name	Class
Bielefeld University	OTHER
University of Witten/Herdecke	OTHER
University Hospital Heidelberg	OTHER
University Hospital Regensburg

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Arm	Experimental	Intensified and patient-centred cooperation between GPs and pharmacists including patient empowerment	Behavioral: PARTNER intervention
Control Arm	Active Comparator	Extended routine care	Behavioral: Control intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PARTNER intervention	Behavioral	The PARTNER intervention includes the following components: Education for health care professionals A) written manual on deprescribing PSA-PIM, which consists of brief information and more detailed explanations; B) access to digital instructional videos/podcasts that address potential problems in deprescribing and provide possible solutions; C) checklist for identification of drug-related problems for pharmacists; D) tapering support tool to facilitate the selection of tapering schemes; E) divisibility list for PSA-PIM to support the implementation of tapering schemes; F) empowerment brochures for patients each focussing on one PSA-PIM subgroup Interprofessional workshop and case conference for GPs and pharmacists Pharmacy visit (brown bag/medication review) including patient empowerment GP practice visit including shared decision making (SDM)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points	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)	6 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points	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)	12 months
Frequency of deprescribing PSA-PIM stratified by PSA-PIM subgroups

Eligibility Module

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tobias Dreischulte, Prof. Dr.	Contact	+49 89 4400 55447		tobias.dreischulte@med.uni-muenchen.de
Annette Haerdtlein	Contact	+49 89 4400 54976		annette.haerdtlein@med.uni-muenchen.de

Name	Affiliation	Role
Tobias Dreischulte, Prof. Dr.	Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Bielefeld	Not yet recruiting	Bielefeld		33615	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41522713	Derived	Haerdtlein A, Bernartz K, Peter S, Lepenies LK, Puzhko S, Eberhardt Y, Maas M, Picker-Huchzermeyer S, Brisnik V, Falomir D, Gensichen J, Steimle T, Huppertz G, Koller M, Zeman F, Vanella P, Seidling HM, Mortsiefer A, Muth C, Dreischulte T. General practitioner-pharmacist collaboration to enhance deprescribing of psychotropics, sedatives, and anticholinergics among older polypharmacy patients in primary care: study protocol of a cluster-randomized controlled trial (PARTNER). Ther Adv Drug Saf. 2026 Jan 8;17:20420986251400042. doi: 10.1177/20420986251400042. eCollection 2026.

IPD Sharing Statement Module

Masking Info