Clinical Trial, Apr/22: Intervention for appropriate benzo/Z-drug prescribing

The full title of this Chinese clinical trial is "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".

https://pubmed.ncbi.nlm.nih.gov/35383066/

Abstract

Introduction: Benzodiazepine receptor agonists (BZRAs), which include benzodiazepines and Z-drugs, are the most commonly prescribed psychotropic drugs worldwide, and their inappropriate use places a significant burden on public health. Given the widespread use of BZRAs in psychiatric settings, this condition may result from doctors' improper prescribing. Researchers have developed an electronic intervention system to assist psychiatrists in prescribing BZRAs appropriately. This study aims to determine the efficacy and utility of electronic intervention in reducing improper BZRAs prescriptions in real-world psychiatric outpatient settings.

Methods and analysis: A multicentre randomised controlled research study will be conducted in real-world settings with licensed psychiatrists with prescription qualifications from five of Chinese most significant regional hospitals that provide high-quality mental healthcare. Participants will be 1:1 randomly assigned to receive a 3-month electronic intervention (11 related information pushing and 3 online lectures) or be placed on a waiting list. The primary outcome is the change in the proportion of inappropriate BZRAs prescriptions between the baseline period (3 months before the intervention) and 3 months after the intervention. Secondary outcomes will be examined at baseline, the third month and the sixth month. The secondary outcomes include psychiatrists' knowledge and attitudes about appropriate BZRAs prescription, the associated side effects of BZRAs among patients and self-efficacy. To measure the utility, intervention assessment and system utilisation data from the intervention group were collected.

Ethics and dissemination: The institutional review board and ethics committees of Shanghai Mental Health Center, Second Xiangya Hospital, West China Hospital, Guangji Hospital and Wuhan Mental Health Center approved the study. After the study is completed, the results will be published in peer-reviewed journals or presented at conferences. If the educational materials are effective, they are available to the general public.

Trial registration number: NCT03724669; Pre-results.