DeprescriptionsPARTNERNCT05842928
Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy
A study testing PARTNER intervention in people with Deprescriptions and Antidepressive Agents, run by Ludwig-Maximilians - University of Munich at 3 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Deprescriptions, Antidepressive Agents, Antipsychotic Agents
- What is being tested?
- PARTNER intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 3 sitesGermany
- Study dates
- 25 Mar 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Not yet recruiting
University of Bielefeld
Bielefeld, 33615
Christiane Muth, Prof. Dr., +49 521 106-67982, christiane.muth@uni-bielefeld.de
Svetlana Puzhko, +49 521 106-86689, svetlana.puzhko@uni-bielefeld.de
- Recruiting
University Hospital, LMU Munich
Munich, 80336
Tobias Dreischulte, Prof. Dr., +49 89 4400 55447, tobias.dreischulte@med.uni-muenchen.de
Annette Haerdtlein, +49 89 4400 54976, annette.haerdtlein@med.uni-muenchen.de
- Not yet recruiting
Witten/Herdecke University
Witten, 58448
Achim Mortsiefer, Prof. Dr., +49 2302 926-7609, achim.mortsiefer@uni-wh.de
Sophie Peter, +49 2302 926-735, sophie.peter@uni-wh.de
About this study
Official title: 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.
- Conditions
- Deprescriptions, Antidepressive Agents, Antipsychotic Agents, Analgesics, Opioid, Hypnotics and Sedatives, Cholinergic Antagonists
- Being tested
- PARTNER intervention, Control intervention
- Keywords
- Polypharmacy, General Practice, Primary Health Care, Pharmacies, Medication Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARTNER interventionBehavioural
The PARTNER intervention includes the following components:
- Education for health care professionals
- written manual on deprescribing PSA-PIM, which consists of brief information and more detailed explanations;
- access to digital instructional videos/podcasts that address potential problems in deprescribing and provide possible solutions;
- checklist for identification of drug-related problems for pharmacists;
- tapering support tool to facilitate the selection of tapering schemes;
- divisibility list for PSA-PIM to support the implementation of tapering schemes;
- 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 interventionBehavioural
The control intervention only comprises a pharmacy visit with brown bag review.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Intensified and patient-centred cooperation between GPs and pharmacists including patient empowerment Receives: Behavioral: PARTNER intervention |
| Control Arm | Active comparator | Extended routine care Receives: Behavioral: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (11)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 months
Cognition (Verbal Fluency Test)
Average (T2 vs T0; T4 vs T0)
Measured: 12 months
Quality of life (EQ5-D-5L)
Average (T2 vs T0; T4 vs T0)
Measured: 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)
Measured: 12 months
Adverse drug reactions (ADRs)
Average (T2 vs T0; T4 vs T0)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start25 Mar 2023
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeprescriptionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Tobias Dreischulte, Ludwig-Maximilians - University of Munich
- Investigators
- Tobias Dreischulte, Prof. Dr., Principal investigator, Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842928
- Sponsor's protocol ID
- 01VSF21038
- Acronym
- PARTNER
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2023
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haerdtlein A, Bernartz K, Peter S, Lepenies LK, Puzhko S, Eberhardt Y, Maas M, Picker-Huchzermeyer S, Brisnik V, Falomir D, Gensichen J, Steimle T, Huppertz G, Koller M, Zeman F, Vanella P, Seidling HM, Mortsiefer A, Muth C, Dreischulte T. General practitioner-pharmacist collaboration to enhance deprescribing of psychotropics, sedatives, and anticholinergics among older polypharmacy patients in primary care: study protocol of a cluster-randomized controlled trial (PARTNER). Ther Adv Drug Saf. 2026 Jan 8;17:20420986251400042. doi: 10.1177/20420986251400042. eCollection 2026.
PubMed 41522713
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy: a Cluster-randomised Trial
- ClinicalTrials.gov ID
- NCT05842928
- Acronym / sponsor ID
- PARTNER / 01VSF21038
- Conditions
- Deprescriptions, Antidepressive Agents, Antipsychotic Agents, Analgesics, Opioid, Hypnotics and Sedatives, Cholinergic Antagonists
- Keywords
- Polypharmacy, General Practice, Primary Health Care, Pharmacies, Medication Safety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- 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
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: PARTNER interventionIntensified and patient-centred cooperation between GPs and pharmacists including patient empowerment |
| Control Arm | Active comparator | Behavioral: Control interventionExtended routine care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARTNER interventionThe 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) | Behavioural | Intervention Arm |
| Control interventionThe control intervention only comprises a pharmacy visit with brown bag review. | Behavioural | Control Arm |
Primary outcome
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)
11 secondary outcomes
Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points
Time frame: 12 months
Frequency of deprescribing PSA-PIM stratified by PSA-PIM subgroups
Time frame: 12 months
Total exposure with PSA-PIM
Time frame: 12 months
Total exposure to PSA-PIM stratified by PSA-PIM subgroups
Time frame: 12 months
Frequency of new PSA-PIM prescriptions
Time frame: 12 months
Frequency of taking other potentially inappropriate medication (PIM) (Validated PIM lists, e.g. PRISCUS list, START/STOPP, Anticholinergic Burden)
Time frame: 12 months
Number of falls and hospitalisations due to fall events (Falls diary, Hospitalisation diary according to FIMA)
Time frame: 12 months
Cognition (Verbal Fluency Test)
Time frame: 12 months
Quality of life (EQ5-D-5L)
Time frame: 12 months
Insomnia (Regensburg Insomnia Scale; RIS)
Time frame: 12 months
Adverse drug reactions (ADRs)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 41522713Haerdtlein A, Bernartz K, Peter S, Lepenies LK, Puzhko S, Eberhardt Y, Maas M, Picker-Huchzermeyer S, Brisnik V, Falomir D, Gensichen J, Steimle T, Huppertz G, Koller M, Zeman F, Vanella P, Seidling HM, Mortsiefer A, Muth C, Dreischulte T. General practitioner-pharmacist collaboration to enhance deprescribing of psychotropics, sedatives, and anticholinergics among older polypharmacy patients in primary care: study protocol of a cluster-randomized controlled trial (PARTNER). Ther Adv Drug Saf. 2026 Jan 8;17:20420986251400042. doi: 10.1177/20420986251400042. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tobias Dreischulte, Prof. Dr. principal investigator
Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARTNER intervention in people with Deprescriptions and Antidepressive Agents, run by Ludwig-Maximilians - University of Munich at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Dreischulte, Prof. Dr. (+49 89 4400 55447, tobias.dreischulte@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the PSA-PIM Drug Burden Index (DBI) by ≥ 0.15 points (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05842928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.