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

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Recruiting

CT.gov ID

NCT05842928

Collaborator

Bielefeld University (Other), University of Witten/Herdecke (Other), University Hospital Heidelberg (Other), University Hospital Regensburg (Other), Institute for Applied Quality Improvement and Research in Health Care (Other), Techniker Krankenkasse (Other), Federal Joint Committee (Other)

352

Enrollment

Locations

Arms

20.3

Anticipated Duration (Months)

117.3

Patients Per Site

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deprescriptions Antidepressive Agents Antipsychotic Agents Analgesics, Opioid Hypnotics and Sedatives Cholinergic Antagonists	Behavioral: PARTNER intervention Behavioral: Control intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

352 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

To avoid selection bias and Hawthorne bias, the collaborating units (GP practice and community pharmacy) in the intervention group are blinded to the target drugs (PSA-PIM) until the time of randomisation, and in the control group until the end of the study. The same applies to patient participants.

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Mar 25, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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 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)
Active Comparator: Control Arm Extended routine care	Behavioral: Control intervention The control intervention only comprises a pharmacy visit with brown bag review.

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 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)

Active Comparator: Control Arm

Extended routine care

Behavioral: Control intervention

The control intervention only comprises a pharmacy visit with brown bag review.

Outcome Measures

Primary Outcome Measures

Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points [6 months]
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)

Secondary Outcome Measures

Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points [12 months]
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 [12 months]
Proportion (%) of patients with a reduction in DBI ≥ 0.15 (T2 vs T0; T4 vs T0)
Total exposure with PSA-PIM [12 months]
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 [12 months]
Average of the Drug Burden Index (DBI); mean change in the number of PSA-PIM taken (T2 vs T0; T4 vs T0)
Frequency of new PSA-PIM prescriptions [12 months]
Proportion (%) of patients with a new prescription of ≥1 PSA-PIM (T2 vs T0; T4 vs T0)
Frequency of taking other potentially inappropriate medication (PIM) (Validated PIM lists, e.g. PRISCUS list, START/STOPP, Anticholinergic Burden) [12 months]
Average change in the number of PIMs (T2 vs T0; T4 vs T0)
Number of falls and hospitalisations due to fall events (Falls diary, Hospitalisation diary according to FIMA) [12 months]
Proportion (%) of patients with falls/hospitalisations due to fall injuries (T2 vs T0; T4 vs T0)
Cognition (Verbal Fluency Test) [12 months]
Average (T2 vs T0; T4 vs T0)
Quality of life (EQ5-D-5L) [12 months]
Average (T2 vs T0; T4 vs T0)
Insomnia (Regensburg Insomnia Scale) [12 months]
Average (T2 vs T0; T4 vs T0)
Adverse drug reactions (ADRs) [12 months]
Average (T2 vs T0; T4 vs T0)

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University of Bielefeld	Bielefeld	Germany	33615
2	University Hospital, LMU Munich	Munich	Germany	80336
3	Witten/Herdecke University	Witten	Germany	58448

Sponsors and Collaborators

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

Investigators

Principal Investigator: Tobias Dreischulte, Prof. Dr., Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany