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A Study of the Effectiveness of Electronic Interventions on the Standardized Prescription Benzodiazepines

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ClinicalTrials.gov Identifier: NCT03724669
Recruitment Status : Unknown
Verified October 2018 by Shanghai Mental Health Center.
Recruitment status was:  Not yet recruiting
First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborators:
Second Xiangya Hospital of Central South University
West China Hospital
Guangji Hospital of suzhou university
Information provided by (Responsible Party):
Shanghai Mental Health Center

Tracking Information
First Submitted Date  ICMJE October 28, 2018
First Posted Date  ICMJE October 30, 2018
Last Update Posted Date October 30, 2018
Estimated Study Start Date  ICMJE December 18, 2018
Estimated Primary Completion Date December 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2018)
benzodiazepines prescription rate within six months [ Time Frame: Baseline and six months ]
Within these six months, the BDZ prescription percentage accounts for all prescription drugs
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2018)
  • completion rate of electronic intervention content reading [ Time Frame: 2 months, 4 months, 6 months ]
    completion rate was defined as the ratio of cpened contents push to participants through the app to the total contents pushed
  • prescription fees of benzodiazepines [ Time Frame: 2 months, 4 months, 6 months ]
    prescription fees of benzodiazepines were assessed at 2 months, 4 months, and 6 months in computerized patient record system
  • participant's overall attitude towards benzodiazepines prescription investigation [ Time Frame: 2 months, 4 months, 6 months ]
    At 2 months, 4 months, and 6 months, each participant's overall attitude towards this benzodiazepines prescription investigation research was assessed using a ten-point scale. The scale is divided into 5 levels: 0 means no discomfort, while 10 means extremely uncomfortable and unbearable.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effectiveness of Electronic Interventions on the Standardized Prescription Benzodiazepines
Official Title  ICMJE A Multi-center Real-world Study of Benzodiazepines Prescription in Psychiatric Clinic, and the Effectiveness of Electronic Interventions on Their Standardized Prescription of These Drugs
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 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 BDZ and improving clinical efficiency.
Detailed Description Benzodiazepines (BDZ) 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 BDZ may have the risk of impairing memory, respiratory depression, and increasing accidents risk. At present, there is no risk investigation on psychiatric BDZ abuse in China, and many psychiatric practitioners lack of knowledge on the standard use of BDZ. The aim of this study was to understand the use of benzodiazepines in psychiatric outpatient clinics in China and to develop a BDZ standardized use electronic intervention guidebook and to verify the effectiveness of this electronic intervention in reducing the use of BDZ in psychiatric outpatient clinics and improving clinical efficiency. Through retrospective surveys and focus interview groups, the study was conducted to understand the use of BDZ and related factors of abuse in psychiatric outpatient clinics in Shanghai, Hunan, Sichuan and Jiangsu provinces. Based on the consensus and guidelines of domestic experts, BDZ 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 BDZ and improving clinical efficiency. The research can deeply understand the use of BDZ in domestic psychiatry and form an effective BDZ standardized electronic intervention manual, which will provide practical value for regulating domestic BDZ in the future.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world Study
Intervention  ICMJE
  • Behavioral: psychiatric related knowledge intervention
    participants receiving psychiatric related knowledge push through the electronic interventions App, once a week, last for six months
  • Behavioral: benzodiazepines related knowledge intervention
    participants receiving benzodiazepines related knowledge push through the electronic interventions App, once a week, last for six months
Study Arms  ICMJE
  • Placebo Comparator: psychiatry knowledge
    Intervention: Behavioral: psychiatric related knowledge intervention
  • Experimental: Benzodiazepines knowledge
    Intervention: Behavioral: benzodiazepines related knowledge intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 28, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 8, 2020
Estimated Primary Completion Date December 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Work as a psychiatric for at least 5 years; participating in psychiatric outpatient service at least 1 year; outpatient time is more than or twice a week; willing to accept electronic BDZ standardized use intervention for half a year.

Exclusion Criteria:

will be retiring within six months participants were not doctors majoring in psychiatrist

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03724669
Other Study ID Numbers  ICMJE NZhong-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai Mental Health Center
Study Sponsor  ICMJE Shanghai Mental Health Center
Collaborators  ICMJE
  • Second Xiangya Hospital of Central South University
  • West China Hospital
  • Guangji Hospital of suzhou university
Investigators  ICMJE
Principal Investigator: Na Zhong, Doctor Shanghai Mental Health Center
PRS Account Shanghai Mental Health Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP