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

Prescribing Outcomes of a General Practitioner-Targeted Deprescribing Educational Intervention in Older Adults With Polypharmacy: A Cluster Randomized Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Frailty Syndrome; Polypharmacy; Deprescriptions; Medication Overuse
• Intervention / Treatment: Other: Medication Reviews and Deprescribing

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Heraklion, Crete
    • Heraklion, Heraklion, Crete, Greece, 71303
      • Primary Care Facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; No educational intervention will be provided to the general practitioners of the selected patients.
Experimental: Intervention Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Crete
• Investigators: Study Chair: Ioanna Tsiligianni, MD, PhD, Associate Professor in General Practice and Public Health, Department of Social Medicine, University of Crete

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Actual): December 30, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drug Misuse; Mental Disorders; Pathologic Processes; Substance-Related Disorders; Chemically-Induced Disorders; Prescription Drug Misuse; Pathological Conditions, Signs and Symptoms; Frailty; Prescription Drug Overuse; Organization and Administration; Health Services Administration; Therapeutics; Drug Therapy; Patient Care Management; Medication Systems; Deprescriptions; Medication Review
• Other Study ID Numbers: 93/12.06.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All the data that will be collected, will be retained only during the period needed for the aims of this research. Technical and organizational measures will be taken in order to minimize potential loss, destruction or corruption of the data.After the completion of the thesis , all the data will be destroyed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No