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

NCT ID: NCT05842928

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-25

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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Intervention Arm

Intensified and patient-centred cooperation between GPs and pharmacists including patient empowerment

Group Type EXPERIMENTAL

PARTNER intervention

Intervention Type BEHAVIORAL

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)

Control Arm

Extended routine care

Group Type ACTIVE_COMPARATOR

Control intervention

Intervention Type BEHAVIORAL

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

Interventions

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PARTNER intervention

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)

Intervention Type BEHAVIORAL

Control intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bielefeld University

OTHER

Sponsor Role collaborator

University of Witten/Herdecke

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role collaborator

University Hospital Regensburg

OTHER

Sponsor Role collaborator

Institute for Applied Quality Improvement and Research in Health Care

UNKNOWN

Sponsor Role collaborator

Techniker Krankenkasse

OTHER

Sponsor Role collaborator

Federal Joint Committee

OTHER_GOV

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Tobias Dreischulte

Professor of Clinical Health Services Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tobias Dreischulte, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany

Locations

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University of Bielefeld

Bielefeld, , Germany

Site Status NOT_YET_RECRUITING

University Hospital, LMU Munich

Munich, , Germany

Site Status RECRUITING

Witten/Herdecke University

Witten, , Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Tobias Dreischulte, Prof. Dr.

Role: CONTACT

+49 89 4400 55447

Annette Haerdtlein

Role: CONTACT

+49 89 4400 54976

Facility Contacts

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Christiane Muth, Prof. Dr.

Role: primary

+49 521 106-67982

Svetlana Puzhko

Role: backup

+49 521 106-86689

Tobias Dreischulte, Prof. Dr.

Role: primary

+49 89 4400 55447

Annette Haerdtlein

Role: backup

+49 89 4400 54976

Achim Mortsiefer, Prof. Dr.

Role: primary

+49 2302 926-7609

Sophie Peter

Role: backup

+49 2302 926-735

Other Identifiers

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01VSF21038

Identifier Type: -

Identifier Source: org_study_id

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