Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID05842928

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

Led by Ludwig-Maximilians - University of Munich · Updated on 2025-05-04

352

Participants Needed

3

Research Sites

26 weeks

Total Duration

On this page

Sponsors

L

Ludwig-Maximilians - University of Munich

Lead Sponsor

B

Bielefeld University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of a patient-centered cooperation between general practitioners (GPs) and community pharmacists on reducing the use of psychotropic, sedative, and anticholinergic potentially inappropriate medications (PSA-PIM) in elderly patients who take multiple medications. This is a multicenter, cluster-randomized trial called the PARTNER study, which compares this intervention to a control group receiving usual care. The study aims to improve medication safety and reduce drug-related risks in older adults with polypharmacy. The intervention group receives an education program for healthcare professionals, including manuals, videos, checklists, and support tools for deprescribing PSA-PIM. It also includes an interprofessional workshop and case conference, a pharmacy visit with medication review and patient empowerment, and a GP practice visit promoting shared decision making. The control group receives only a pharmacy visit with medication review. Both interventions involve collaboration between GPs, pharmacists, and patients to address medication use. Participants are adults aged 65 or older who use at least five medications including one or more PSA-PIM for six months or more. They must be willing to select a regular pharmacy and consent to data sharing between their GP and pharmacy. The study measures reduction in PSA-PIM Drug Burden Index over 6 and 12 months, along with medication exposure, new prescriptions, falls, hospitalizations, cognition, quality of life, insomnia, and adverse drug reactions. Participants will be monitored through medication reviews, questionnaires, and diaries during the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 65 years or older
  • Capable of giving consent
  • Contacted general practitioner in the prior quarter
  • Currently using 5 or more drugs including at least 1 psychotropic, sedative, or anticholinergic medication for 6 months or longer
  • Willing to select a regular pharmacy for the study period
  • Consent to data exchange between general practitioner and community pharmacy
Not Eligible

You will not qualify if you...

  • Terminal illness with life expectancy less than 6 months
  • Current treatment for cancer-related pain
  • Serious physical illness or mental distress making participation impossible (per GP assessment)
  • Psychiatric illness or addiction making participation impossible (per GP assessment)
  • Unable to participate in telephone or written questionnaires or visits needed for the study
  • Currently participating in other research on medication safety or geriatric medicine

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 months

Participants receive either intensified and patient-centred cooperation between general practitioners and pharmacists including patient empowerment or extended routine care involving a pharmacy visit with brown bag medication review.

1 to 2 visits including pharmacy and GP practice visits depending on intervention assignment

Trial Site Locations

Total: 3 locations

1

University of Bielefeld

Bielefeld, Germany, 33615

Not Yet Recruiting

2

University Hospital, LMU Munich

Munich, Germany, 80336

Actively Recruiting

3

Witten/Herdecke University

Witten, Germany, 58448

Not Yet Recruiting

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Research Team

T

Tobias Dreischulte, Prof. Dr.

A

Annette Haerdtlein

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

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).

Annette Haerdtlein, Kerstin Bernartz, Sophie Peter...

https://pubmed.ncbi.nlm.nih.gov/41522713