Clinical trial NCT03724669: A Study of the Effectiveness of Electronic Interventions on the Standardized Prescription Benzodiazepines and Z-drugs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world Study
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Second Xiangya Hospital of Central South University
name: West China Hospital
name: Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University
name: Wuhan Mental Health Centre
First posted: 2018-10-30
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: proportion of inappropriate BZDs and Z-drugs prescription
timeFrame: 3 months before and after the intervention
Secondary outcomes:
measure: BZDs and Z-drugs related knowledge
timeFrame: baseline, 3 months, 6 months
measure: Attitude towards BZDs and Z-drugs prescription
timeFrame: baseline, 3 months, 6 months
measure: Common adverse effects in prescribing patients
timeFrame: baseline, 3 months, 6 months
measure: Self-efficacy
timeFrame: baseline, 3 months, 6 months
measure: Utility of the electronic intervention
timeFrame: 3 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Na Zhong, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.