Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy

NCT05842928 | Recruiting DMC

• 1 other identifier: 01VSF21038
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Deprescriptions; Antidepressive Agents; Antipsychotic Agents; Analgesics, Opioid; Hypnotics and Sedatives; Cholinergic Antagonists

Keywords

Polypharmacy; General Practice; Primary Health Care; Pharmacies; Medication Safety

Outcome Measures

Primary Outcomes (1)

• 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 (11)

• Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points

  12 months

• Frequency of deprescribing PSA-PIM stratified by PSA-PIM subgroups

  12 months

• Total exposure with PSA-PIM

  12 months

• Total exposure to PSA-PIM stratified by PSA-PIM subgroups

  12 months

• Frequency of new PSA-PIM prescriptions

  12 months

Study Arms (2)

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

PARTNER intervention BEHAVIORAL

The PARTNER intervention includes the following components: 1. 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 2. Interprofessional workshop and case conference for GPs and pharmacists 3. Pharmacy visit (brown bag/medication review) including patient empowerment 4. GP practice visit including shared decision making (SDM)

Intervention Arm

Control intervention BEHAVIORAL

The control intervention only comprises a pharmacy visit with brown bag review.

Control Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 years or older
• Patient is capable of giving consent
• Current use of ≥ 5 drugs, including ≥ 1 PSA-PIM (hypnotics, opioids, gabapentinoids, antipsychotics, antidepressants, anticholinergic urospasmolytics) with a treatment duration of ≥ 6 months
• Willingness to select a regular pharmacy for the study period
• Consent to data exchange between GP and community pharmacy

You may not qualify if:

• Terminal illness (life expectancy \< 6 months)
• Current treatment of pain associated with cancer
• Other serious physical illness or mental distress (e.g. bereavement) that makes participation in the study impossible (according to the GP's assessment)
• Psychiatric illness or addiction that makes participation in the study impossible (according to the GP's assessment)
• 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)
• Current participation in research projects on medication safety or geriatric medicine

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Bielefeld University: collaborator
• University of Witten/Herdecke: collaborator
• University Hospital Heidelberg: collaborator
• University Hospital Regensburg: collaborator
• Institute for Applied Quality Improvement and Research in Health Care: collaborator
• Techniker Krankenkasse: collaborator
• Federal Joint Committee: collaborator

Study Sites (3)

University of Bielefeld

Bielefeld, 33615, Germany

NOT YET RECRUITING

University Hospital, LMU Munich

Munich, 80336, Germany

RECRUITING

Witten/Herdecke University

Witten, 58448, Germany

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 41522713 DERIVED

Study Officials

• Tobias Dreischulte, Prof. Dr.

  Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Health Services Research

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: March 25, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)