Clinical trial NCT06470308: Inappropriate Polypharmacy in Elderly Patients in Primary Care and Deprescribing in Older Patients With Frailty
Official title: Inappropriate Polypharmacy in Elderly Patients in Primary Care and Deprescribing in Older Patients With Frailty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Medication Overuse
Deprescriptions
Polypharmacy
Frailty Syndrome
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 255
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Potentially Inappropriate Medication
timeFrame: 1 years
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: 1 year
measure: Medication adherence
timeFrame: 1 year
measure: Frailty Status
timeFrame: 1 year
measure: Number of falls
timeFrame: 1 year
measure: Depression
timeFrame: 1 year
measure: Fear of falling
timeFrame: 1 year
measure: Emergency department visits and hospitalisations
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: Primary Care Facilities
state: Heraklion, Crete
Study officials:
affiliation: Associate Professor in General Practice and Public Health, Department of Social Medicine, University of Crete
name: Ioanna Tsiligianni, MD, PhD
role: STUDY_CHAIR
References: