Prescribing Outcomes of a GP-Targeted Deprescribing Educational Intervention: A Cluster Randomized Trial

NCT06470308 | Active Not Recruiting

• 1 other identifier: 93/12.06.2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Polypharmacy is a common and growing public health concern across healthcare settings worldwide and is associated with an increased risk of inappropriate prescribing and adverse drug events. Deprescribing-defined as the supervised withdrawal of potentially inappropriate medications using structured tools and clinical judgment-has been proposed as a strategy to improve prescribing safety. In Greece, formal initiatives and evidence evaluating deprescribing interventions in primary care remain limited. This study is a cluster randomized controlled trial evaluating the effect of an educational intervention for general practitioners (GPs) on prescribing safety in primary care. Participating GPs are randomized in an approximately 1:1 ratio to an intervention or control arm. GPs in the intervention arm receive structured education and training on medication review and deprescribing, including the use of validated deprescribing tools such as the Beers Criteria. GPs in the control arm provide usual care and do not receive any educational intervention. Patients receiving care from participating GPs are recruited, and prescribing outcomes are assessed at the patient level. The primary outcome is change in prescription medications following the intervention, comparing patients cared for by GPs in the intervention arm versus those cared for by GPs in the control arm.

Conditions

Medication Overuse; Deprescriptions; Polypharmacy; Frailty Syndrome

Outcome Measures

Primary Outcomes (2)

• Potentially Inappropriate Medication

  Determine if there is reduction in potentially Inappropriate medication after a deprescribing education intervention

  1 years

• Number of medications

  Determine if there is reduction in number of medications after a deprescribing education intervention

  1 year

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Other: Medication Reviews and Deprescribing

Control Arm

NO INTERVENTION

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

Interventions

Medication Reviews and Deprescribing 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.

Intervention Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• hospitalized or patients living in nursing home
• Incapable of giving written consent

Sponsors & Collaborators

• University of Crete: lead

Study Sites (1)

Primary Care Facilities

Heraklion, Heraklion, Crete, 71303, Greece

Location

MeSH Terms

Conditions

Prescription Drug Overuse; Frailty

Interventions

Medication Review; Deprescriptions

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management; Drug Therapy; Therapeutics

Study Officials

• Ioanna Tsiligianni, MD, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD , PhD Candidate

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: November 18, 2024
• Primary Completion: December 30, 2025
• Study Completion: March 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)