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

Analgesics, Opioid Clinical Trial

— PARTNER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842928
• Other study ID #: 01VSF21038
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Ludwig-Maximilians - University of Munich
• Contact: Tobias Dreischulte, Prof. Dr.
• Phone: +49 89 4400 55447
• Email: tobias.dreischulte[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• PARTNER intervention
The PARTNER intervention includes the following components: 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 Interprofessional workshop and case conference for GPs and pharmacists Pharmacy visit (brown bag/medication review) including patient empowerment GP practice visit including shared decision making (SDM)
• Control intervention
The control intervention only comprises a pharmacy visit with brown bag review.

Locations

Country	Name	City	State
Germany	University of Bielefeld	Bielefeld
Germany	University Hospital, LMU Munich	Munich
Germany	Witten/Herdecke University	Witten

Sponsors (8)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Bielefeld University, Federal Joint Committee, Institute for Applied Quality Improvement and Research in Health Care, Techniker Krankenkasse, University Hospital Heidelberg, University Hospital Regensburg, University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Secondary	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)	12 months
Secondary	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)	12 months
Secondary	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)	12 months
Secondary	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)	12 months
Secondary	Frequency of new PSA-PIM prescriptions	Proportion (%) of patients with a new prescription of =1 PSA-PIM (T2 vs T0; T4 vs T0)	12 months
Secondary	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)	12 months
Secondary	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)	12 months
Secondary	Cognition (Verbal Fluency Test)	Average (T2 vs T0; T4 vs T0)	12 months
Secondary	Quality of life (EQ5-D-5L)	Average (T2 vs T0; T4 vs T0)	12 months
Secondary	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)	12 months
Secondary	Adverse drug reactions (ADRs)	Average (T2 vs T0; T4 vs T0)	12 months