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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Behavioral: PARTNER intervention
* Behavioral: Control intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Intensified and patient-centred cooperation between GPs and pharmacists including patient empowerment | Behavioral: PARTNER intervention<br>* 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)<br>|
| Active Comparator: Control Arm<br>Extended routine care | Behavioral: Control intervention<br>* The control intervention only comprises a pharmacy visit with brown bag review.<br>|

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 | 
| 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 | 
| Adverse drug reactions (ADRs) | Average (T2 vs T0; T4 vs T0) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polypharmacy, General Practice, Primary Health Care, Pharmacies, Medication Safety