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NCT Number: NCT05842928

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bielefeld, Bielefeld, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PARTNER intervention

Behavioral

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

Behavioral

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

Primary outcomes

  1. Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points

    Time frame: 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 outcomes

  1. Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points

    Time frame: 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)

  2. Frequency of deprescribing PSA-PIM stratified by PSA-PIM subgroups

    Time frame: 12 months

    Proportion (%) of patients with a reduction in DBI ≥ 0.15 (T2 vs T0; T4 vs T0)

  3. Total exposure with PSA-PIM

    Time frame: 12 months

    Average of the Drug Burden Index (DBI); mean change in the number of PSA-PIM taken (T2 vs T0; T4 vs T0)

  4. Total exposure to PSA-PIM stratified by PSA-PIM subgroups

    Time frame: 12 months

    Average of the Drug Burden Index (DBI); mean change in the number of PSA-PIM taken (T2 vs T0; T4 vs T0)

  5. Frequency of new PSA-PIM prescriptions

    Time frame: 12 months

    Proportion (%) of patients with a new prescription of ≥1 PSA-PIM (T2 vs T0; T4 vs T0)

  6. Frequency of taking other potentially inappropriate medication (PIM) (Validated PIM lists, e.g. PRISCUS list, START/STOPP, Anticholinergic Burden)

    Time frame: 12 months

    Average change in the number of PIMs (T2 vs T0; T4 vs T0)

  7. Number of falls and hospitalisations due to fall events (Falls diary, Hospitalisation diary according to FIMA)

    Time frame: 12 months

    Proportion (%) of patients with falls/hospitalisations due to fall injuries (T2 vs T0; T4 vs T0)

  8. Cognition (Verbal Fluency Test)

    Time frame: 12 months

    Average (T2 vs T0; T4 vs T0)

  9. Quality of life (EQ5-D-5L)

    Time frame: 12 months

    Average (T2 vs T0; T4 vs T0)

  10. Insomnia (Regensburg Insomnia Scale; RIS)

    Time frame: 12 months

    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)

  11. Adverse drug reactions (ADRs)

    Time frame: 12 months

    Average (T2 vs T0; T4 vs T0)

Study contacts

Contact information is provided by the study sponsor or research team.

Annette Haerdtlein

CONTACT

[email protected]

+49 89 4400 54976

Tobias Dreischulte, Prof. Dr.

CONTACT

[email protected]

+49 89 4400 55447

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: PARTNER

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 6, 2023
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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