Inappropriate Polypharmacy in Elderly Patients in Primary Care and Deprescribing in Older Patients With Frailty

NCT ID: NCT06470308

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2026-01-31

Brief Summary

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Polypharmacy is a major and growing public health problem occuring within all health care settings worldwide. The systematic review of Mansoon et al,2017 identified 138 different definitions for polypharmacy from which the most commonly used numerical definition is being this of five or more medicines. However, numerical definitions do not take into account factors such as comorbidity thus there is a need for a a shift towards the terms "appropriate" ,and "inappropriate polypharmacy" and potentially inappropriate prescribing (PIP). The prevalence of polypharmacy varies between 10% to as high as around 90% depending on the definition used and the population that is studied.There is worldwide literature regarding the epidemiology of polypharmacy in the elderly , health outcomes and cost. The is an abundance of guidelines and tools regarding deprescribing, the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing polypharmacy , minimizing inappropriate medication and improving outcomes. In Greece , as pointed out by the SIMPATHY project, there is no formal polypharmacy initiative and relative greek literature is scarce.There is no research in Greece regarding the prevalence of PIP among community-dwelling elderly patients as well as there are no studies evaluating the feasibility or effectiveness of deprescribing interventions in the elderly or older patients with frailty.

The aim of this thesis is to record, in the primary care setting in Crete, the underlying barriers and enablers of deprescribing among health care professionals and also to evaluate ,the clinical outcomes of deprescribing interventions in primary care. Additionally, the beliefs and attitudes of the patients and/or their caregivers towards deprescribing will be recorded.

Detailed Description

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Conditions

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Medication Overuse Deprescriptions Polypharmacy Frailty Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Arm

An educational intervention and training in deprescribing algorithms and deprescribing tools ( Beers Criteria, STOPP/START) will be provided to the general practitioners caring for the patients selected in the intervention arm.

Group Type EXPERIMENTAL

Medication Reviews and Deprescribing

Intervention Type OTHER

General Practitioners will be given training and education in deprescribing algorithms and the conduction of medication reviews with the use of validated deprescribing tools such as the Beers Criteria and STOPP/START criteria.

Control Arm

No educational intervention will be provided to the general practitioners of the selected patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Medication Reviews and Deprescribing

General Practitioners will be given training and education in deprescribing algorithms and the conduction of medication reviews with the use of validated deprescribing tools such as the Beers Criteria and STOPP/START criteria.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* community-dwelling patients
* Age ≥ 65 years
* Receive at least 5 medication ( polypharmacy )

Exclusion Criteria

* hospitalized or patients living in nursing home
* Incapable of giving written consent
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Crete

OTHER

Sponsor Role lead

Responsible Party

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Alexandros Paraskevopoulos

MD , PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ioanna Tsiligianni, MD, PhD

Role: STUDY_CHAIR

Associate Professor in General Practice and Public Health, Department of Social Medicine, University of Crete

Locations

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Primary Care Facilities

Heraklion, Heraklion, Crete, Greece

Site Status

Countries

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Greece

Other Identifiers

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93/12.06.2023

Identifier Type: -

Identifier Source: org_study_id

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