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Recruiting NCT05842928

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

No phase Interventional Deprescriptions Antidepressive Agents Antipsychotic Agents Analgesics, Opioid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PARTNER intervention, Control intervention.
Who it may be relevant to
Registry conditions: Deprescriptions, Antidepressive Agents, Antipsychotic Agents, Analgesics, Opioid. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy: a Cluster-randomised Trial

Overview

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.

Interventions

  • Behavioral PARTNER intervention
    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 taperi
  • Behavioral Control intervention
    The control intervention only comprises a pharmacy visit with brown bag review.

Primary outcome measures

  • Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points [Time frame: 6 months]
Secondary outcome measures (11)
  • Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points [Time frame: 12 months]
  • Frequency of deprescribing PSA-PIM stratified by PSA-PIM subgroups [Time frame: 12 months]
  • Total exposure with PSA-PIM [Time frame: 12 months]
  • Total exposure to PSA-PIM stratified by PSA-PIM subgroups [Time frame: 12 months]
  • Frequency of new PSA-PIM prescriptions [Time frame: 12 months]
  • Frequency of taking other potentially inappropriate medication (PIM) (Validated PIM lists, e.g. PRISCUS list, START/STOPP, Anticholinergic Burden) [Time frame: 12 months]
  • Number of falls and hospitalisations due to fall events (Falls diary, Hospitalisation diary according to FIMA) [Time frame: 12 months]
  • Cognition (Verbal Fluency Test) [Time frame: 12 months]
  • Quality of life (EQ5-D-5L) [Time frame: 12 months]
  • Insomnia (Regensburg Insomnia Scale; RIS) [Time frame: 12 months]
  • Adverse drug reactions (ADRs) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Aged 65 years or older
  • Patient is capable of giving consent
  • GP contact in the quarter prior to inclusion
  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Health services research

Study locations

Germany · 3 centers
  • University of Bielefeld — Bielefeld
  • University Hospital, LMU Munich — Munich
  • Witten/Herdecke University — Witten

Publications

  • 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 pr PMID 41522713

Identifiers

NCT: NCT05842928 · 01VSF21038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗