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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 : 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

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.

Condition or disease Intervention/treatment Phase
Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world Study Behavioral: psychiatric related knowledge intervention Behavioral: benzodiazepines related knowledge intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : December 18, 2018
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : May 8, 2020

Arm Intervention/treatment
Placebo Comparator: psychiatry knowledge Behavioral: psychiatric related knowledge intervention
participants receiving psychiatric related knowledge push through the electronic interventions App, once a week, last for six months

Experimental: Benzodiazepines knowledge Behavioral: benzodiazepines related knowledge intervention
participants receiving benzodiazepines related knowledge push through the electronic interventions App, once a week, last for six months




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724669


Contacts
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Contact: Na Zhong, Doctor 008613671644472 winco917@hotmail.com

Sponsors and Collaborators
Shanghai Mental Health Center
Second Xiangya Hospital of Central South University
West China Hospital
Guangji Hospital of suzhou university
Investigators
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Principal Investigator: Na Zhong, Doctor Shanghai Mental Health Center

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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03724669     History of Changes
Other Study ID Numbers: NZhong-001
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No