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

Inappropriate Prescribing Clinical Trial

— BENZOSTOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06209827
• Other study ID #: IFLBZD16
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2024
• Source: Andalusian Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inappropriate Prescribing

Intervention

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.

Locations

Country	Name	City	State
Spain	Ingrid Ferrer López	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Andalusian Health Service	Andalusian School of Public Health

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dispensing of benzodiazepines.	Number of dispensing of benzodiazepines, measured at the level of the participant.	3.5 years
Secondary	Knowledge	Knowledge: Empower questionary, measured at the level of the participant.	6 months
Secondary	Life Quality	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