Clinical trial NCT05842928: Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy
Official title: Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy: a Cluster-randomised Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deprescriptions
Antidepressive Agents
Antipsychotic Agents
Analgesics, Opioid
Hypnotics and Sedatives
Cholinergic Antagonists
Keywords: Polypharmacy
General Practice
Primary Health Care
Pharmacies
Medication Safety
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Bielefeld University
name: University of Witten/Herdecke
name: University Hospital Heidelberg
name: University Hospital Regensburg
name: Institute for Applied Quality Improvement and Research in Health Care
name: Techniker Krankenkasse
name: Federal Joint Committee
First posted: 2023-05-06
Enrollment: 352
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points
timeFrame: 6 months
Secondary outcomes:
measure: Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points
timeFrame: 12 months
measure: Frequency of deprescribing PSA-PIM stratified by PSA-PIM subgroups
timeFrame: 12 months
measure: Total exposure with PSA-PIM
timeFrame: 12 months
measure: Total exposure to PSA-PIM stratified by PSA-PIM subgroups
timeFrame: 12 months
measure: Frequency of new PSA-PIM prescriptions
timeFrame: 12 months
measure: Frequency of taking other potentially inappropriate medication (PIM) (Validated PIM lists, e.g. PRISCUS list, START/STOPP, Anticholinergic Burden)
timeFrame: 12 months
measure: Number of falls and hospitalisations due to fall events (Falls diary, Hospitalisation diary according to FIMA)
timeFrame: 12 months
measure: Cognition (Verbal Fluency Test)
timeFrame: 12 months
measure: Quality of life (EQ5-D-5L)
timeFrame: 12 months
measure: Insomnia (Regensburg Insomnia Scale; RIS)
timeFrame: 12 months
measure: Adverse drug reactions (ADRs)
timeFrame: 12 months
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: University of Bielefeld
city: Munich
country: Germany
facility: University Hospital, LMU Munich
city: Witten
country: Germany
facility: Witten/Herdecke University
Study officials:
affiliation: Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany
name: Tobias Dreischulte, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: