A Study of the Effectiveness of Electronic Interventions on the Standardized Prescription Benzodiazepines and Z-drugs

Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world Study Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724669
• Other study ID #: NZhong-001
• Status: Completed
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. at least 3-year working experience as a psychiatrist;

2. provide outpatient services for at least 1 year with the frequency of more than once a week;

3. willingness to receive standardized electronic interventions on BZDs and Z-drugs prescription.

Exclusion Criteria:

1. will retire within six months;

2. refuse to extract their prescription information from the outpatient database.

Related Conditions & MeSH terms

• Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world Study

Intervention

Behavioral:
• waiting list
After the study ends, they will have access to receive the educational texts and view the online lectures.
• benzodiazepines related knowledge intervention
participants receiving 11 articles pushing and 3 online lectures through the electronic interventions App, once a week, last for 3 months

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Second Xiangya Hospital of Central South University, Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University, West China Hospital, Wuhan Mental Health Centre

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of inappropriate BZDs and Z-drugs prescription	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.	3 months before and after the intervention
Secondary	BZDs and Z-drugs related knowledge	22-item self-made questionnaite about BZDs and Z-drugs related knowledge	baseline, 3 months, 6 months
Secondary	Attitude towards BZDs and Z-drugs prescription	14-item self-made questionnaite about attitude towards BZDs and Z-drugs prescription	baseline, 3 months, 6 months
Secondary	Common adverse effects in prescribing patients	8-item self-made questionnaite about common adverse effects in prescribing patients	baseline, 3 months, 6 months
Secondary	Self-efficacy	An adapted 10-item version of General Self-Efficacy Scale (GSES) will be used to measure participants' self-efficacy.	baseline, 3 months, 6 months
Secondary	Utility of the electronic intervention	an online 17-item questionnaire to evaluate the intervention and utilization data will be automatically collected through the platform	3 month