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

NCT03724669 | Completed

• 1 other identifier: NZhong-001
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 Arms (2)

waiting list

PLACEBO COMPARATOR

Behavioral: waiting list

Benzodiazepines and Z-drugs knowledge

EXPERIMENTAL

Behavioral: benzodiazepines related knowledge intervention

Interventions

waiting list BEHAVIORAL

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

waiting list

benzodiazepines related knowledge intervention BEHAVIORAL

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

Benzodiazepines and Z-drugs knowledge

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Second Xiangya Hospital of Central South University: collaborator
• West China Hospital: collaborator
• Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University: collaborator
• Wuhan Mental Health Centre: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 35383066 DERIVED

MeSH Terms

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Na Zhong, Doctor

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: October 30, 2018
• Study Start: November 10, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 10, 2022

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)