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Clinical Trials/NCT03724669
NCT03724669
Completed
Not Applicable

A Multi-center Real-world Study of Benzodiazepines and Z-drugs Prescription in Psychiatric Clinic, and the Effectiveness of Electronic Interventions on Their Standardized Prescription of These Drugs

Shanghai Mental Health Center1 site in 1 country118 target enrollmentNovember 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world Study
Sponsor
Shanghai Mental Health Center
Enrollment
118
Locations
1
Primary Endpoint
proportion of inappropriate BZDs and Z-drugs prescription
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

A retrospective surveys and group interviews focusing on the prescription and abuse of benzodiazepines will be carried out in China. Based the results of retrospective surveys and group interviews and guidelines of benzodiazepines and Z-drugs standardized use, a real-world randomized control trial of would be carried to evaluate the effectiveness of the intervention of using electronic content push in reducing the use rate of psychiatric BZDs and Z-drugs and improving clinical efficiency.

Detailed Description

Benzodiazepines (BZDs) and Z-drugs are commonly used sedative and hypnotic drugs in psychiatry. A small number of studies have suggestted that there may be improper use or even abuse in recent years. Long-term use of BZDs and Z-drugs may have the risk of impairing memory, respiratory depression, and increasing accidents risk. At present, there is no risk investigation on psychiatric BZDs and Z-drugs abuse in China, and many psychiatric practitioners lack of knowledge on the standard use of BZDs and Z-drugs. The aim of this study was to understand the use of benzodiazepines in psychiatric outpatient clinics in China and to develop a BZDs and Z-drugs standardized use electronic intervention guidebook and to verify the effectiveness of this electronic intervention in reducing the use of BZDs and Z-drugs in psychiatric outpatient clinics and improving clinical efficiency. Through retrospective surveys and focus interview groups, the study was conducted to understand the use of BZDs and Z-drugs and related factors of abuse in psychiatric outpatient clinics in Shanghai, Hunan, Sichuan, Wuhan and Jiangsu provinces. Based on the consensus and guidelines of domestic experts, BZDs and Z-drugs standardized electronic intervention was used. The real-world randomized controlled research method was combined with electronic content push and periodic electronic evaluation to evaluate the effectiveness of the intervention in reducing the use rate of psychiatric BZDs and Z-drugs and improving clinical efficiency. The research can deeply understand the use of BZDs and Z-drugs in domestic psychiatry and form an effective BZDs and Z-drugs standardized electronic intervention manual, which will provide practical value for regulating domestic BZDs and Z-drugs in the future.

Registry
clinicaltrials.gov
Start Date
November 10, 2020
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • at least 3-year working experience as a psychiatrist;
  • provide outpatient services for at least 1 year with the frequency of more than once a week;
  • willingness to receive standardized electronic interventions on BZDs and Z-drugs prescription.

Exclusion Criteria

  • will retire within six months;
  • refuse to extract their prescription information from the outpatient database.

Outcomes

Primary Outcomes

proportion of inappropriate BZDs and Z-drugs prescription

Time Frame: 3 months before and after the intervention

The BZDs and Z-drugs prescription information of each psychiatrist within the baseline period (3 months before the intervention) and intervention period (0-3 month) will be extracted from the outpatient prescription database in each hospital. The inappropriate prescription is defined as overdose use (\>40mg), long-term use (\>90 days) or over-indications use.

Secondary Outcomes

  • BZDs and Z-drugs related knowledge(baseline, 3 months, 6 months)
  • Attitude towards BZDs and Z-drugs prescription(baseline, 3 months, 6 months)
  • Common adverse effects in prescribing patients(baseline, 3 months, 6 months)
  • Self-efficacy(baseline, 3 months, 6 months)
  • Utility of the electronic intervention(3 month)

Study Sites (1)

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