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临床试验/NCT04504162
NCT04504162Unknown不适用

Iatrogenic Addiction to Sedation in Shanghai

Shanghai Mental Health Center0 个研究点目标入组 100,000 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100,000
主要终点
Outpatient's prescription

研究概览

简要总结

This study will establish a sedative and hypnotics iatrogenic addiction risk monitoring network composed of 4 psychiatric hospitals in Shanghai through standardized data construction of outpatient prescription data and personnel training. Develop a sedative-hypnotic addiction risk prediction tool based on patient prescription data, and use independent in-operation outpatient prescription data for verification, and carry out clinical application promotion.

详细描述

This study is a longitudinal analysis of the outpatient prescription data of psychiatric hospitals. It includes two aspects: 1) Develop evaluation methods for the risk of sedative-hypnotic addiction in psychiatric hospitals; 2) Construct a predictive model for the risk of iatrogenic addiction to sedative-hypnotics.

Step 1. Export all sedative hypnotic prescription information from the outpatient medical record system of Shanghai Psychiatric Hospital.

The data range is from January 1, 2019 to December 31, 2020. The data items that need to be exported include: patient identification information, gender, age, diagnosis, prescription drug name, drug use method, total dose, time , and the physician number of the prescription. Generate a unique patient number based on identification information (such as ID number), and merge all prescription information and electronic medical records of the same patient during the study period.

Step 2. Identify patients at risk of addiction to sedative hypnotics. This study defines the risk of addiction to sedatives and hypnotics when the outpatients appear "double off-label prescriptions". The standard of "double off-label prescriptions" is: the highest daily average dose of prescriptions obtained by patients>60 mg diazepam equivalent milligrams, and the number of consecutive prescription days>120 days. Firstly, mark whether the patient has a prescription that exceeds the specification range (over indication, over daily dose range, over treatment course) during the study period. Secondly, the analysis data set is further converted and labeled, including: all benzodiazepine doses are converted into diazepam equivalents according to the "Benzazepine Dose Conversion Table". Calculate the "average daily prescription dose" for each patient: add up the prescriptions of benzodiazepines to get the total prescription, and divide by the number of days to get the average daily prescription dose. Finally, calculate the monthly or annual cases or proportion of "double off-label prescriptions" patients who are at risk of addiction to sedatives and hypnotics.

Step 3.Establish a risk prediction model for iatrogenic addiction to sedative and hypnotics in psychiatric hospitals.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Outpatient's prescription

时间窗: Data from January 1, 2019 to December 31, 2020

The research object is the outpatient prescription information of each independent year (2019, 2020) of each hospital (4 hospitals), including: patient identification information, gender, age, diagnosis, prescription drug name, drug use method, total dose, time , And the physician number of the prescription. Generate a unique patient number based on identification information (such as ID number), and merge all prescription information and electronic medical records of the same patient during the study period. And mark whether the patient has a prescription that exceeds the specification range (over indication, over daily dose range, over treatment course) during the study period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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