DeprescriptionsNCT05609981
Optimising Medication With Focus on Deprescribing in Frail Older People With Multidose Drug Dispensing Systems
A study testing Clinical medication review focused on deprescribing in people with Deprescriptions and Polypharmacy, run by SIR Institute for Pharmacy Practice and Policy at 1 site in Netherlands.
Trial summary
Overuse is common in frail older people with polypharmacy, especially in frail older users of multidose drug dispensing (MDD) systems. In this study, we will investigate the effect of a clinical medication review (CMR) with integration of deprescribing (toolbox) on the number of ceased and dose lowered medications… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Deprescriptions, Polypharmacy, Primary Health Care
- What is being tested?
- Clinical medication review focused on deprescribing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Nov 2022to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- using a multidose drug dispensing system
- hyperpolypharmacy patient (using 10 drugs or more)
- age: 75 years or older
Who cannot join
- received a CMR in the previous 12 months
- incapacitated
- patients for whom the general practitioner is not the primary practionar
- expected lifespan of less than six motnhs
- patients who live in a nursing home
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
SIR Institute for Pharmacy Practice and Policy
Leiden, South Holland, 3604DP
About this study
Official title: Optimising Medication With Focus on Deprescribing in Frail Older People With Multidose Drug
Overuse is common in frail older people with polypharmacy, especially in frail older users of multidose drug dispensing (MDD) systems. In this study, we will investigate the effect of a clinical medication review (CMR) with integration of deprescribing (toolbox) on the number of ceased and dose lowered medications (persistent after 6 months) compared to usual care in older users of MDD systems with hyperpolypharmacy.
We will perform a controlled cluster-randomized trial in 38 community pharmacies. Per pharmacy, 10 older patients (>= 75) with hyperpolyfpharmacy (>10 medicines in use) with a MDD will be included. Pharmacists will receive training to perform the intervention, a 5-step CMR with a deprescribing toolbox (including deprescribing protocols): 1) patient interview; 2) pharmacotherapeutic analysis; 3) pharmacist and GP discuss actions; 4) actions are discussed with patient; 5) (two)weekly follow-up.
Read the detailed description
AIM: is to investigate the effect of a clinical medication review in combination with a toolbox about deprescribing.
STUDY DESIGN: a controlled cluster-randomized trial will be performed, in which participating pharmacists in the Netherlands will be randomized to conduct clinical medication reviews with 10 eligible patients (intervention) or to provide usual care (control).
STUDY POPULATION: hyperpolypharmacy (≥ 10 chronic drugs) older patients (≥75 years) using a multidose drug dispensing (MDD) system
INTERVENTION: the intervention at t=0 consists of a 5-step patient-centred CMR focuses on deprescribing supported by the toolbox developed in WP1. The CMR starts with a patient interview (step 1) by a community pharmacist focussing on patient's preferences with input from the questionnaires on healthproblems, frailty and patient wishes. After the pharmacotherapeutic analysis (step 2), the pharmacist and the GP discuss the identified patient preferences and possible actions, including deprescribing (step 3). When patients are treated for one of more disease by a hospital specialist, pharmacist or GP consults this physician when appropriate. The health care providers decide together with the patient which actions will be conducted and their priority. This will result in a pharmaceutical care plan taking into account the tapering schemes from the deprescribing protocols (step 4). All actions and deprescribing steps will be evaluated with the patient during at least two follow-up moments (or more according to the patient's needs) to monitor the results of the actions. The follow-up moments can be performed by nurse practitioners or GPs with consultation of the community pharmacist when needed, e.g. to adapt tapering schemes based on the patient's health problems or withdrawal symptoms (step 5).
CONTROL: usual care.
OUTCOME MEASURES: the primary outcome measure is the number of ceased or dose lowered drugs per patient persistent after 6 months. Secondary, PREMs and PROMs including quality of life will be measured, as well as intermediate outcomes and process related outcomes
DATA-ANALYSIS: Intention-to-treat analysis and a per-protocol-analysis for the primary outcome and PROM, and an explorative subgroup analysis (age, gender, health problems, number of medicines in use). Descriptive analysis of other outcomes (intervention group only).
SAMPLE SIZE: To detect an effect size of 1 ceased / dose lowered drug (standard deviation 2.5), 80% power and α=0.05, we need a total of 266 patients for the analysis of the primary outcome and to account for clustering effects within pharmacies (ICC = 0,05 and clustersize = 7). Taking loss to follow-up into account (35%), 38 teams need to recruit 10 patients each.
- Being tested
- Clinical medication review focused on deprescribing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical medication review focused on deprescribingOther
A pharmacist-led intervention consisting of a clinical medication review with the focus on deprescribing in older patients using multidose drug dispensing (MDD) systems.
Pharmacist are trained in deprescribing and a developed toolbox to support the intervention is provided
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | The intervention at t=0 consists of a 5-step patient-centred CMR focused on deprescribing supported by a toolbox provided to the pharmacists Receives: Other: Clinical medication review focused on deprescribing |
| Control | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of ceased or dose lowered drugs per patient
number of ceased or dose lowered drugs per patient based on dispensing data
Measured: 6 months after the start of the medication review (t = 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start10 Nov 2022
- Primary completion21 Feb 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIR Institute for Pharmacy Practice and Policy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609981
- Sponsor's protocol ID
- UPF2211
- Other IDs
- 80-86600-98-19512
- Status last verified
- Jul 2025
- First submitted
- 2 Nov 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Medication With Focus on Deprescribing in Frail Older People With Multidose Drug
- ClinicalTrials.gov ID
- NCT05609981
- Acronym / sponsor ID
- UPF2211
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- SIR Institute for Pharmacy Practice and PolicyUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 8 Nov 2022 (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.
Overuse is common in frail older people with polypharmacy, especially in frail older users of multidose drug dispensing (MDD) systems. In this study, we will investigate the effect of a clinical medication review (CMR) with integration of deprescribing (toolbox) on the number of ceased and dose lowered medications (persistent after 6 months) compared to usual care in older users of MDD systems with hyperpolypharmacy.
We will perform a controlled cluster-randomized trial in 38 community pharmacies. Per pharmacy, 10 older patients (>= 75) with hyperpolyfpharmacy (>10 medicines in use) with a MDD will be included. Pharmacists will receive training to perform the intervention, a 5-step CMR with a deprescribing toolbox (including deprescribing protocols): 1) patient interview; 2) pharmacotherapeutic analysis; 3) pharmacist and GP discuss actions; 4) actions are discussed with patient; 5) (two)weekly follow-up.
Detailed description
AIM: is to investigate the effect of a clinical medication review in combination with a toolbox about deprescribing.
STUDY DESIGN: a controlled cluster-randomized trial will be performed, in which participating pharmacists in the Netherlands will be randomized to conduct clinical medication reviews with 10 eligible patients (intervention) or to provide usual care (control).
STUDY POPULATION: hyperpolypharmacy (≥ 10 chronic drugs) older patients (≥75 years) using a multidose drug dispensing (MDD) system
INTERVENTION: the intervention at t=0 consists of a 5-step patient-centred CMR focuses on deprescribing supported by the toolbox developed in WP1. The CMR starts with a patient interview (step 1) by a community pharmacist focussing on patient's preferences with input from the questionnaires on healthproblems, frailty and patient wishes. After the pharmacotherapeutic analysis (step 2), the pharmacist and the GP discuss the identified patient preferences and possible actions, including deprescribing (step 3). When patients are treated for one of more disease by a hospital specialist, pharmacist or GP consults this physician when appropriate. The health care providers decide together with the patient which actions will be conducted and their priority. This will result in a pharmaceutical care plan taking into account the tapering schemes from the deprescribing protocols (step 4). All actions and deprescribing steps will be evaluated with the patient during at least two follow-up moments (or more according to the patient's needs) to monitor the results of the actions. The follow-up moments can be performed by nurse practitioners or GPs with consultation of the community pharmacist when needed, e.g. to adapt tapering schemes based on the patient's health problems or withdrawal symptoms (step 5).
CONTROL: usual care.
OUTCOME MEASURES: the primary outcome measure is the number of ceased or dose lowered drugs per patient persistent after 6 months. Secondary, PREMs and PROMs including quality of life will be measured, as well as intermediate outcomes and process related outcomes
DATA-ANALYSIS: Intention-to-treat analysis and a per-protocol-analysis for the primary outcome and PROM, and an explorative subgroup analysis (age, gender, health problems, number of medicines in use). Descriptive analysis of other outcomes (intervention group only).
SAMPLE SIZE: To detect an effect size of 1 ceased / dose lowered drug (standard deviation 2.5), 80% power and α=0.05, we need a total of 266 patients for the analysis of the primary outcome and to account for clustering effects within pharmacies (ICC = 0,05 and clustersize = 7). Taking loss to follow-up into account (35%), 38 teams need to recruit 10 patients each.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Clinical medication review focused on deprescribingThe intervention at t=0 consists of a 5-step patient-centred CMR focused on deprescribing supported by a toolbox provided to the pharmacists |
| Control | No intervention | –Usual care. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- using a multidose drug dispensing system
- hyperpolypharmacy patient (using 10 drugs or more)
- age: 75 years or older
Key exclusion criteria (5 listed)
- received a CMR in the previous 12 months
- incapacitated
- patients for whom the general practitioner is not the primary practionar
- expected lifespan of less than six motnhs
- patients who live in a nursing home
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 |
|---|---|---|
| Clinical medication review focused on deprescribingA pharmacist-led intervention consisting of a clinical medication review with the focus on deprescribing in older patients using multidose drug dispensing (MDD) systems. Pharmacist are trained in deprescribing and a developed toolbox to support the intervention is provided | Other | Intervention |
Primary outcome
number of ceased or dose lowered drugs per patient
Time frame: 6 months after the start of the medication review (t = 6 months)
number of ceased or dose lowered drugs per patient based on dispensing data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical medication review focused on deprescribing in people with Deprescriptions and Polypharmacy, run by SIR Institute for Pharmacy Practice and Policy at 1 site in Netherlands.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of ceased or dose lowered drugs per patient (time frame: 6 months after the start of the medication review (t = 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2025.