Effectiveness of a Community Intervention in the Chronic Use of Benzodiazepines: (BENZOSTOPJUNTOS) (BENZOSTOP)

January 31, 2024 updated by: Ingrid Ferrer López, Andalusian Health Service

Effectiveness of a Multidisciplinary Intervention in the Reduction of Benzodiazepine Prescriptions: A Cluster Controlled Trial

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for Benzodiazepines withdrawal compared to standard care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The excessive use of benzodiazepines (BZDs) presents significant health concerns and high healthcare costs, particularly in Spain, where usage rates are among the highest globally. In Andalusian, over a 10% of the population use BZDs long-term, prompting the need for safe and effective reduction strategies.

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for BZD withdrawal compared to standard care.

The intervention involved educational discussions, consultations with health professionals, and letters supported by multiple scientific societies.

Study Type

Interventional

Enrollment (Actual)

472

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41011
        • Ingrid Ferrer López

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • users of health centre's with more than 4 weeks of benzodiazepines use.
  • users of health centre's over 18 years of age.

Exclusion Criteria:

  • users of health centre's with mental disorder.
  • users of health centre's terminal.
  • users of health centre's with alcohol dependence.
  • users of health centre's with dementia.
  • users of health centre's who had intellectual disabilities.
  • users of health centre's unable to cooperate with the questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: Intervention for reducing benzodiazepines long-term use.

It included the multiple components as follows:

(i) an exchange discussion with the patient describing the advantages, disadvantages and alternatives of benzodiazepines use and a tapering protocol with the support of educational material, (ii) the offer of a brief, if necessary, consultation with the family doctor, and (iii) a letter addressed to the patient supported by scientific societies.
Behavioral: Intervention for reducing benzodiazepines long-term use.

Comprehensive, multicomponent intervention utilizing education and support for benzodiazepines.

Family doctor, nurse, community pharmacist and social workers: carried out informative discussion with the patient with by providing educational material. They informed patients about the advantages, disadvantages and alternatives to benzodiazepines including a descending benzodiazepines schedule to minimize withdrawal symptoms. It briefly explained the professionals' concerns about the continued use of benzodiazepines and offers possible solutions.

If the patient requested a withdrawal, he/she was referred to the doctor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of dispensing of benzodiazepines.
Time Frame: 3.5 years
Number of dispensing of benzodiazepines, measured at the level of the participant.
3.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge
Time Frame: 6 months
Knowledge: Empower questionary, measured at the level of the participant.
6 months
Life Quality
Time Frame: 6 months

Quality of life:Functional Status Measurement Sheets by coop World Organisation of Family Doctors (COOP/ WONCA):

The six COOP-WONCA Charts are described by vignettes and measured at the level of the participant: physical fitness, feelings, daily activities, social activities, change in health and overall health.

WONCA: World Organisation of Family Doctors
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andalusian Health Service

Collaborators

Andalusian School of Public Health

Investigators

  • Principal Investigator: Ingrid Ferrer López, Ph.D, SAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

January 6, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IFLBZD16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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