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

Not Applicable

Recruiting

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

• Registration Number: NCT05842928
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-25
• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-04
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 352

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Frequency of taking other potentially inappropriate medication (PIM) (Validated PIM lists, e.g. PRISCUS list, START/STOPP, Anticholinergic Burden)	12 months	Average change in the number of PIMs (T2 vs T0; T4 vs T0)
Quality of life (EQ5-D-5L)	12 months	Average (T2 vs T0; T4 vs T0)
Total exposure with PSA-PIM	12 months	Average of the Drug Burden Index (DBI); mean change in the number of PSA-PIM taken (T2 vs T0; T4 vs T0)
Frequency of new PSA-PIM prescriptions	12 months	Proportion (%) of patients with a new prescription of ≥1 PSA-PIM (T2 vs T0; T4 vs T0)
Number of falls and hospitalisations due to fall events (Falls diary, Hospitalisation diary according to FIMA)	12 months	Proportion (%) of patients with falls/hospitalisations due to fall injuries (T2 vs T0; T4 vs T0)
Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points	12 months	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)
Total exposure to PSA-PIM stratified by PSA-PIM subgroups	12 months	Average of the Drug Burden Index (DBI); mean change in the number of PSA-PIM taken (T2 vs T0; T4 vs T0)
Frequency of deprescribing PSA-PIM stratified by PSA-PIM subgroups	12 months	Proportion (%) of patients with a reduction in DBI ≥ 0.15 (T2 vs T0; T4 vs T0)
Cognition (Verbal Fluency Test)	12 months	Average (T2 vs T0; T4 vs T0)
Adverse drug reactions (ADRs)	12 months	Average (T2 vs T0; T4 vs T0)
Insomnia (Regensburg Insomnia Scale; RIS)	12 months	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.; Average (T2 vs T0; T4 vs T0)

Trial Locations

Locations (3)

University of Bielefeld; 🇩🇪 Bielefeld, Germany

University Hospital, LMU Munich; 🇩🇪 Munich, Germany

Witten/Herdecke University; 🇩🇪 Witten, Germany