- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06470308
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
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Heraklion, Crete
-
Heraklion, Heraklion, Crete, Greece, 71303
- Primary Care Facilities
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
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)
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.
|
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
Time Frame: 1 years
|
Determine if there is reduction in potentially Inappropriate medication after a deprescribing education intervention
|
1 years
|
|
Number of medications
Time Frame: 1 year
|
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
Time Frame: 1 year
|
Evaluate if there is change in Health-Related Quality of Life using a validated questionnaire
|
1 year
|
|
Medication adherence
Time Frame: 1 year
|
Evaluate if there is change in medication adherence using a validated questionnaire
|
1 year
|
|
Frailty Status
Time Frame: 1 year
|
evaluation of frailty using a validated score
|
1 year
|
|
Depression
Time Frame: 1 year
|
evaluation of geriatric depression using a validated questionnaire
|
1 year
|
|
Fear of falling
Time Frame: 1 year
|
Evaluate if there is change in fear of falling using a validated questionnaire
|
1 year
|
|
Number of falls
Time Frame: 1 year
|
evaluation of self-reported falls
|
1 year
|
|
Emergency department visits and hospitalisations
Time Frame: 1 year
|
Evaluation of the number of emergency department visits and hospitalisations (self reported)
|
1 year
|
Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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