NCT05609981

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

November 2, 2022

Last Update Submit

July 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of ceased or dose lowered drugs per patient

    number of ceased or dose lowered drugs per patient based on dispensing data

    6 months after the start of the medication review (t = 6 months)

Study Arms (2)

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

Other: Clinical medication review focused on deprescribing

Control

NO INTERVENTION

Usual care.

Interventions

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

Intervention

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • using a multidose drug dispensing system
  • hyperpolypharmacy patient (using 10 drugs or more)
  • age: 75 years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SIR Institute for Pharmacy Practice and Policy

Leiden, South Holland, 3604DP, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 8, 2022

Study Start

November 10, 2022

Primary Completion

February 21, 2025

Study Completion

June 27, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations