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

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

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.

Study Overview

• Status: Completed
• Conditions: Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world Study
• Intervention / Treatment: Behavioral: waiting list; Behavioral: benzodiazepines related knowledge intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: waiting list	Behavioral: waiting list; After the study ends, they will have access to receive the educational texts and view the online lectures.
Experimental: Benzodiazepines and Z-drugs knowledge	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BZDs and Z-drugs related knowledge	22-item self-made questionnaite about BZDs and Z-drugs related knowledge	baseline, 3 months, 6 months
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
Common adverse effects in prescribing patients	8-item self-made questionnaite about common adverse effects in prescribing patients	baseline, 3 months, 6 months
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
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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: West China Hospital; Wuhan Mental Health Centre; Second Xiangya Hospital of Central South University; Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University
• Investigators: Principal Investigator: Na Zhong, Doctor, Shanghai Mental Health Center

Publications and helpful links

General Publications

• Xu X, Ye Y, Wang X, Xu J, Li C, Wang G, Zhu Y, Jiang H, Zhong N. Effectiveness and utility of an electronic intervention for appropriate benzodiazepine and Z-drugs prescription in psychiatric clinics: protocol for a multicentric, real-world randomised controlled trial in China. BMJ Open. 2022 Apr 5;12(4):e055341. doi: 10.1136/bmjopen-2021-055341.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: October 28, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: NZhong-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The prescription data will not be shared with the public. However, if the intervention is effective, the educational materials will be released to the public.

Drug and device information, study documents

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