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.
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
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)
Parallel
PARTNER intervention
BehavioralThe 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)
Control intervention
BehavioralThe control intervention only comprises a pharmacy visit with brown bag review.
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)
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)
Frequency of deprescribing PSA-PIM stratified by PSA-PIM subgroups
Proportion (%) of patients with a reduction in DBI ≥ 0.15 (T2 vs T0; T4 vs T0)
Total exposure with PSA-PIM
Average of the Drug Burden Index (DBI); mean change in the number of PSA-PIM taken (T2 vs T0; T4 vs T0)
Total exposure to PSA-PIM stratified by PSA-PIM subgroups
Average of the Drug Burden Index (DBI); mean change in the number of PSA-PIM taken (T2 vs T0; T4 vs T0)
Click on the lead sponsor to view all of their trials.
Ludwig-Maximilians - University of Munich
Lead sponsor
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
