Informative Exhibition for Deprescribing Benzodiazepines (ESUB)

Impact of an Interactive and Informative Exhibition on Benzodiazepine Use on Deprescription.

The goal of this trial is to determine if an interactive and informative exhibition in the waiting room of a Primary Care Clinic can reduce the use of benzodiazepines in adults. The main question it aims to answer is:

• Does an interactive and informative exhibition reduce the number of participants using benzodiazepines? Researchers will compare benzodiazepine consumption before and after the interactive and informative exhibition implementation at study center.

Participants will receive an informative and interactive exhibition on the risks of chronic benzodiazepine use. A single informative session on the same topic will be conducted for health professionals.

Study Overview

• Status: Recruiting
• Conditions: Benzodiazepine-Related Disorders
• Intervention / Treatment: Other: Informative Session

• Study Type: Observational
• Enrollment (Estimated): 6410

Contacts and Locations

• Study Contact: Name: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
• Study Contact Backup: Name: Jordi Milozzi, MD; Phone Number: +34 938 10 30 03; Email: jmilozzi@csapg.cat

Study Locations

• Spain
  • Barcelona
    • Vilanova I La Geltrú, Barcelona, Spain
      • Recruiting
      • Centro de Salud Vilanova i la Geltrú 3 Baix A Mar
      • Contact: Noemí Casaponsa; Phone Number: 43197 +34 938960026; Email: recerca@csapg.cat
      • Contact: Jordi Milozzi, MD; Phone Number: +34 938 10 30 03; Email: jmilozzi@csapg.cat
      • Principal Investigator: Jordi Milozzi, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Community population assigned to a primary care center.

Description

Inclusion Criteria:

• Men and women between 18 and 99 years of age.
• Attended at the Baix-a-Mar Primary Care Center during the study period.

Exclusion Criteria:

• Severe mental health disease
• Displaced patients or those who do not have an assigned doctor at the center.
• Participation in another study involving an experimental intervention during the period of the present study that affects benzodiazepine prescription.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before intervention; This group will consist of patients who attended the primary care center before the implementation of the intervention.
After intervention; This group will consist of patients who will attend the primary care center after the implementation of the intervention.	Other: Informative Session; The intervention consists of implementing an interactive exhibition on the risks of chronic benzodiazepine treatment in the waiting room of a primary care center. Additionally, the health professionals at the center will receive a single informative session on the same topic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic treatment with benzodiazepines	Percentage of patients treated chronically with benzodiazepines, based on electronic prescription data.	1 year

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: Jordi Milozzi, MD, Centro de Salud Vilanova i la Geltrú 3 Baix A Mar-CSAPG

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Benzodiazepines; Deprescriptions
• Other Study ID Numbers: CSAPG-59

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
• IPD Sharing Time Frame: After publication of main results of the study.
• IPD Sharing Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No