Monitoring and Risk Prediction of Iatrogenic Sedative Hypnotics Addiction in a Shanghai Psychiatric Hospital

Addiction Clinical Trial

Official title:

Iatrogenic Addiction to Sedation in Shanghai

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04504162
• Other study ID #: HFJiang-005
• Status: Not yet recruiting
• Start date: August 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2020
• Source: Shanghai Mental Health Center
• Contact: Haifeng Jiang, Dr.
• Phone: (86)-021-64906315
• Email: dragonjhf[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Use correlation analysis or machine learning methods to explore the formation trajectory of the "double off-label" pattern of sedative hypnotic prescriptions, and build a predictive model that can predict the formation of the "double off-label" pattern. Use a subset of prescription data to identify patients with status of "double off-label", then evaluate and review them to confirm the addiction status of sedatives and hypnotics. Use the validation subset to verify and improve the addiction risk prediction model based on the training data set.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100000
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

This study is a data analysis based on outpatient visit records. The research object is the prescription data of outpatient visits during the research period, that is, the prescription information of any patient visiting the outpatient clinic during the research period will be included in the analysis.

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive
• Hypnotics and Sedatives

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outpatient's prescription	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.	Data from January 1, 2019 to December 31, 2020