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

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

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 Overview

• Status: Recruiting
• Conditions: Antipsychotic Agents; Antidepressive Agents; Analgesics, Opioid; Deprescriptions; Hypnotics and Sedatives; Cholinergic Antagonists
• Intervention / Treatment: Behavioral: PARTNER intervention; Behavioral: Control intervention

• Study Type: Interventional
• Enrollment (Anticipated): 352
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Dreischulte, Prof. Dr.; Phone Number: +49 89 4400 55447; Email: tobias.dreischulte@med.uni-muenchen.de
• Study Contact Backup: Name: Annette Haerdtlein; Phone Number: +49 89 4400 54976; Email: annette.haerdtlein@med.uni-muenchen.de

Study Locations

• Germany
  • Bielefeld, Germany, 33615
    • Not yet recruiting
    • University of Bielefeld
    • Contact: Christiane Muth, Prof. Dr.; Phone Number: +49 521 106-67982; Email: christiane.muth@uni-bielefeld.de
    • Contact: Svetlana Puzhko; Phone Number: +49 521 106-86689; Email: svetlana.puzhko@uni-bielefeld.de
  • Munich, Germany, 80336
    • Recruiting
    • University Hospital, LMU Munich
    • Contact: Tobias Dreischulte, Prof. Dr.; Phone Number: +49 89 4400 55447; Email: tobias.dreischulte@med.uni-muenchen.de
    • Contact: Annette Haerdtlein; Phone Number: +49 89 4400 54976; Email: annette.haerdtlein@med.uni-muenchen.de
  • Witten, Germany, 58448
    • Not yet recruiting
    • Witten/Herdecke University
    • Contact: Achim Mortsiefer, Prof. Dr.; Phone Number: +49 2302 926-7609; Email: achim.mortsiefer@uni-wh.de
    • Contact: Sophie Peter; Phone Number: +49 2302 926-735; Email: sophie.peter@uni-wh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Intensified and patient-centred cooperation between GPs and pharmacists including patient empowerment	Behavioral: PARTNER intervention; The PARTNER intervention includes the following components: Education for health care professionalsA) 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)
Active Comparator: Control Arm; Extended routine care	Behavioral: Control intervention; The control intervention only comprises a pharmacy visit with brown bag review.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Cognition (Verbal Fluency Test)	Average (T2 vs T0; T4 vs T0)	12 months
Quality of life (EQ5-D-5L)	Average (T2 vs T0; T4 vs T0)	12 months
Adverse drug reactions (ADRs)	Average (T2 vs T0; T4 vs T0)	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)	12 months

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: University Hospital Heidelberg; University of Witten/Herdecke; University Hospital Regensburg; Bielefeld University; Techniker Krankenkasse; Federal Joint Committee; Institute for Applied Quality Improvement and Research in Health Care
• Investigators: Principal Investigator: Tobias Dreischulte, Prof. Dr., Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2023
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Primary Health Care; Polypharmacy; General Practice; Pharmacies; Medication Safety
• Other Study ID Numbers: 01VSF21038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No