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

NCT ID: NCT03724669

Last Updated: 2022-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

waiting list

Group Type PLACEBO_COMPARATOR

waiting list

Intervention Type BEHAVIORAL

After the study ends, they will have access to receive the educational texts and view the online lectures.

Benzodiazepines and Z-drugs knowledge

Group Type EXPERIMENTAL

benzodiazepines related knowledge intervention

Intervention Type BEHAVIORAL

participants receiving 11 articles pushing and 3 online lectures through the electronic interventions App, once a week, last for 3 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

waiting list

After the study ends, they will have access to receive the educational texts and view the online lectures.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University

UNKNOWN

Sponsor Role collaborator

Wuhan Mental Health Centre

OTHER

Sponsor Role collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Na Zhong, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Mental Health Center

Shanghai, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35383066 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NZhong-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Smartphones Aggravating Anxiety Symptoms
NCT06361342 ACTIVE_NOT_RECRUITING NA