Optimising Medication With Focus on Deprescribing in Frail Older People With Multidose Drug Dispensing Systems
NCT ID: NCT05609981
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
318 participants
INTERVENTIONAL
2022-11-10
2025-06-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MODIFY or Medication Review in Primary Care Study
NCT05705284
Deprescribing in a Long Term Care Facility
NCT03091153
Inappropriate Polypharmacy in Elderly Patients in Primary Care and Deprescribing in Older Patients With Frailty
NCT06470308
Bundled Hyperpolypharmacy Deprescribing
NCT05616689
Deprescribing in Primary Health Care
NCT03903484
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
The intervention at t=0 consists of a 5-step patient-centred CMR focused on deprescribing supported by a toolbox provided to the pharmacists
Clinical medication review focused on deprescribing
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
Control
Usual care.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical medication review focused on deprescribing
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* hyperpolypharmacy patient (using 10 drugs or more)
* age: 75 years or older
Exclusion Criteria
* 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
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SIR Institute for Pharmacy Practice and Policy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SIR Institute for Pharmacy Practice and Policy
Leiden, South Holland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
80-86600-98-19512
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UPF2211
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.