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

Not Applicable

Active, not recruiting

• Conditions: Medication Overuse; Deprescriptions; Frailty Syndrome; Polypharmacy
• Interventions: Other: Medication Reviews and Deprescribing

• Registration Number: NCT06470308
• Lead Sponsor: University of Crete

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-24
• Study Start: 2024-11-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Medication Reviews and Deprescribing	Medication reviews will be conducted for patients in the intervention arm , using deprescribing tools such as the STOPP/START criteria and the Beers Criteria. Then an educational intervention will be conducted to general practitioners caring for the patients in the invervention arm, regarding the findings of the medication reviews and how they were conducted. Also training in deprescribing algorithms will be provided.

Primary Outcome Measures

Name	Time	Method
Potentially Inappropriate Medication	1 years	Determine if there is reduction in potentially Inappropriate medication after a deprescribing education intervention

Secondary Outcome Measures

Name	Time	Method
Emergency department visits and hospitalisations	1 year	Evaluation of the number of emergency department visits and hospitalisations (self reported)
Fear of falling	1 year	Evaluate if there is change in fear of falling using a validated questionnaire
Health-Related Quality of Life	1 year	Evaluate if there is change in Health-Related Quality of Life using a validated questionnaire
Medication adherence	1 year	Evaluate if there is change in medication adherence using a validated questionnaire
Frailty Status	1 year	evaluation of frailty using a validated score
Number of falls	1 year	evaluation of self-reported falls
Depression	1 year	evaluation of geriatric depression using a validated questionnaire

Trial Locations

Locations (1)

Primary Care Facilities; 🇬🇷 Heraklion, Heraklion, Crete, Greece