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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
352
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)
The control intervention only comprises a pharmacy visit with brown bag review.
University of Bielefeld
Bielefeld, Germany
NOT_YET_RECRUITINGUniversity Hospital, LMU Munich
Munich, Germany
RECRUITINGWitten/Herdecke University
Witten, Germany
NOT_YET_RECRUITINGReduction 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)
Time frame: 6 months
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)
Time frame: 12 months
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)
Time frame: 12 months
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)
Time frame: 12 months
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)
Time frame: 12 months
Frequency of new PSA-PIM prescriptions
Proportion (%) of patients with a new prescription of ≥1 PSA-PIM (T2 vs T0; T4 vs T0)
Time frame: 12 months
Frequency of taking other potentially inappropriate medication (PIM) (Validated PIM lists, e.g. PRISCUS list, START/STOPP, Anticholinergic Burden)
Average change in the number of PIMs (T2 vs T0; T4 vs T0)
Time frame: 12 months
Number of falls and hospitalisations due to fall events (Falls diary, Hospitalisation diary according to FIMA)
Proportion (%) of patients with falls/hospitalisations due to fall injuries (T2 vs T0; T4 vs T0)
Time frame: 12 months
Cognition (Verbal Fluency Test)
Average (T2 vs T0; T4 vs T0)
Time frame: 12 months
Quality of life (EQ5-D-5L)
Average (T2 vs T0; T4 vs T0)
Time frame: 12 months
Insomnia (Regensburg Insomnia Scale; RIS)
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)
Time frame: 12 months
Adverse drug reactions (ADRs)
Average (T2 vs T0; T4 vs T0)
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.