Hypnotics and SedativesNCT04504162
Monitoring and Risk Prediction of Iatrogenic Sedative Hypnotics Addiction in a Shanghai Psychiatric Hospital
An observational study of Hypnotics and Sedatives and Addiction, run by Shanghai Mental Health Center.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypnotics and Sedatives, Addiction
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient visiting the outpatient clinic of Shanghai mental health center during the research period will be included in the analysis.
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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Iatrogenic Addiction to Sedation in Shanghai
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.
Read the detailed 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.
- Conditions
- Hypnotics and Sedatives, Addiction
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| outpatient | Patients visiting a psychiatric hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data from January 1, 2019 to December 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Aug 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypnotics and SedativesStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504162
- Sponsor's protocol ID
- HFJiang-005
- Status last verified
- Jul 2020
- First submitted
- 5 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will share results within the scope of Chinese laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iatrogenic Addiction to Sedation in Shanghai
- ClinicalTrials.gov ID
- NCT04504162
- Acronym / sponsor ID
- HFJiang-005
- Conditions
- Hypnotics and Sedatives, Addiction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outpatient | – | –Patients visiting a psychiatric hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient visiting the outpatient clinic of Shanghai mental health center during the research period will be included in the analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Outpatient's prescription
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: Undecided. Will share results within the scope of Chinese laws and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypnotics and Sedatives and Addiction, run by Shanghai Mental Health Center.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haifeng Jiang, Dr. ((86)-021-64906315, dragonjhf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outpatient's prescription (time frame: Data from January 1, 2019 to December 31, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.