Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world StudyNCT03724669
A Study of the Effectiveness of Electronic Interventions on the Standardized Prescription Benzodiazepines and Z-drugs
A study testing waiting list and benzodiazepines related knowledge intervention in people with Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world Study, run by Shanghai Mental Health Center at 1 site in China.
Trial 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 and Z-drugs standardized use, a real-world randomized control trial of would be carried… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world Study
- What is being tested?
- waiting list and benzodiazepines related knowledge intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2020to 31 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- at least 3-year working experience as a psychiatrist;
- provide outpatient services for at least 1 year with the frequency of more than once a week;
- willingness to receive standardized electronic interventions on BZDs and Z-drugs prescription.
Who cannot join
- will retire within six months;
- refuse to extract their prescription information from the outpatient database.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center Real-world Study of Benzodiazepines and Z-drugs Prescription in Psychiatric Clinic, and the Effectiveness of Electronic Interventions on Their Standardized Prescription of These Drugs
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 and Z-drugs 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 BZDs and Z-drugs and improving clinical efficiency.
Read the detailed description
Benzodiazepines (BZDs) and Z-drugs 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 BZDs and Z-drugs may have the risk of impairing memory, respiratory depression, and increasing accidents risk. At present, there is no risk investigation on psychiatric BZDs and Z-drugs abuse in China, and many psychiatric practitioners lack of knowledge on the standard use of BZDs and Z-drugs. The aim of this study was to understand the use of benzodiazepines in psychiatric outpatient clinics in China and to develop a BZDs and Z-drugs standardized use electronic intervention guidebook and to verify the effectiveness of this electronic intervention in reducing the use of BZDs and Z-drugs in psychiatric outpatient clinics and improving clinical efficiency. Through retrospective surveys and focus interview groups, the study was conducted to understand the use of BZDs and Z-drugs and related factors of abuse in psychiatric outpatient clinics in Shanghai, Hunan, Sichuan, Wuhan and Jiangsu provinces. Based on the consensus and guidelines of domestic experts, BZDs and Z-drugs 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 BZDs and Z-drugs and improving clinical efficiency. The research can deeply understand the use of BZDs and Z-drugs in domestic psychiatry and form an effective BZDs and Z-drugs standardized electronic intervention manual, which will provide practical value for regulating domestic BZDs and Z-drugs in the future.
- Being tested
- waiting list, benzodiazepines related knowledge intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waiting listBehavioural
After the study ends, they will have access to receive the educational texts and view the online lectures.
benzodiazepines related knowledge interventionBehavioural
participants receiving 11 articles pushing and 3 online lectures through the electronic interventions App, once a week, last for 3 months
| Study group | Role | What they receive |
|---|---|---|
| waiting list | Placebo comparator | Not described Receives: Behavioral: waiting list |
| Benzodiazepines and Z-drugs knowledge | Experimental | Not described Receives: Behavioral: benzodiazepines related knowledge intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of inappropriate BZDs and Z-drugs prescription
The BZDs and Z-drugs prescription information of each psychiatrist within the baseline period (3 months before the intervention) and intervention period (0-3 month) will be extracted from the outpatient prescription database in each hospital. The inappropriate prescription is defined as overdose use (>40mg), long-term use (>90 days) or over-indications use.
Measured: 3 months before and after the intervention
Secondary outcomes (5)
BZDs and Z-drugs related knowledge
22-item self-made questionnaite about BZDs and Z-drugs related knowledge
Measured: baseline, 3 months, 6 months
Attitude towards BZDs and Z-drugs prescription
14-item self-made questionnaite about attitude towards BZDs and Z-drugs prescription
Measured: baseline, 3 months, 6 months
Common adverse effects in prescribing patients
8-item self-made questionnaite about common adverse effects in prescribing patients
Measured: baseline, 3 months, 6 months
Self-efficacy
An adapted 10-item version of General Self-Efficacy Scale (GSES) will be used to measure participants' self-efficacy.
Measured: baseline, 3 months, 6 months
Utility of the electronic intervention
an online 17-item questionnaire to evaluate the intervention and utilization data will be automatically collected through the platform
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start10 Nov 2020
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world StudyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, West China Hospital, Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University, Wuhan Mental Health Centre
- Responsible party
- Sponsor
- Investigators
- Na Zhong, Doctor, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724669
- Sponsor's protocol ID
- NZhong-001
- Status last verified
- Jun 2020
- First submitted
- 28 Oct 2018
- Last updated
- 10 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The prescription data will not be shared with the public. However, if the intervention is effective, the educational materials will be released to the public.
Publications
Xu X, Ye Y, Wang X, Xu J, Li C, Wang G, Zhu Y, Jiang H, Zhong N. 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. BMJ Open. 2022 Apr 5;12(4):e055341. doi: 10.1136/bmjopen-2021-055341.
PubMed 35383066
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Real-world Study of Benzodiazepines and Z-drugs Prescription in Psychiatric Clinic, and the Effectiveness of Electronic Interventions on Their Standardized Prescription of These Drugs
- ClinicalTrials.gov ID
- NCT03724669
- Acronym / sponsor ID
- NZhong-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, West China Hospital, Suzhou Psychiatric Hospital, The Affiliated Guangji Hospital of Soochow University, Wuhan Mental Health Centre
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Oct 2018 (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.
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 and Z-drugs 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 BZDs and Z-drugs and improving clinical efficiency.
Detailed description
Benzodiazepines (BZDs) and Z-drugs 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 BZDs and Z-drugs may have the risk of impairing memory, respiratory depression, and increasing accidents risk. At present, there is no risk investigation on psychiatric BZDs and Z-drugs abuse in China, and many psychiatric practitioners lack of knowledge on the standard use of BZDs and Z-drugs. The aim of this study was to understand the use of benzodiazepines in psychiatric outpatient clinics in China and to develop a BZDs and Z-drugs standardized use electronic intervention guidebook and to verify the effectiveness of this electronic intervention in reducing the use of BZDs and Z-drugs in psychiatric outpatient clinics and improving clinical efficiency. Through retrospective surveys and focus interview groups, the study was conducted to understand the use of BZDs and Z-drugs and related factors of abuse in psychiatric outpatient clinics in Shanghai, Hunan, Sichuan, Wuhan and Jiangsu provinces. Based on the consensus and guidelines of domestic experts, BZDs and Z-drugs 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 BZDs and Z-drugs and improving clinical efficiency. The research can deeply understand the use of BZDs and Z-drugs in domestic psychiatry and form an effective BZDs and Z-drugs standardized electronic intervention manual, which will provide practical value for regulating domestic BZDs and Z-drugs in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| waiting list | Placebo comparator | Behavioral: waiting list |
| Benzodiazepines and Z-drugs knowledge | Experimental | Behavioral: benzodiazepines related knowledge intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- at least 3-year working experience as a psychiatrist;
- provide outpatient services for at least 1 year with the frequency of more than once a week;
- willingness to receive standardized electronic interventions on BZDs and Z-drugs prescription.
Key exclusion criteria (2 listed)
- will retire within six months;
- refuse to extract their prescription information from the outpatient database.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| waiting listAfter the study ends, they will have access to receive the educational texts and view the online lectures. | Behavioural | waiting list |
| benzodiazepines related knowledge interventionparticipants receiving 11 articles pushing and 3 online lectures through the electronic interventions App, once a week, last for 3 months | Behavioural | Benzodiazepines and Z-drugs knowledge |
Primary outcome
proportion of inappropriate BZDs and Z-drugs prescription
Time frame: 3 months before and after the intervention
The BZDs and Z-drugs prescription information of each psychiatrist within the baseline period (3 months before the intervention) and intervention period (0-3 month) will be extracted from the outpatient prescription database in each hospital. The inappropriate prescription is defined as overdose use (>40mg), long-term use (>90 days) or over-indications use.
5 secondary outcomes
BZDs and Z-drugs related knowledge
Time frame: baseline, 3 months, 6 months
Attitude towards BZDs and Z-drugs prescription
Time frame: baseline, 3 months, 6 months
Common adverse effects in prescribing patients
Time frame: baseline, 3 months, 6 months
Self-efficacy
Time frame: baseline, 3 months, 6 months
Utility of the electronic intervention
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Derived from this study: PubMed 35383066Xu X, Ye Y, Wang X, Xu J, Li C, Wang G, Zhu Y, Jiang H, Zhong N. 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. BMJ Open. 2022 Apr 5;12(4):e055341. doi: 10.1136/bmjopen-2021-055341.
- Individual participant dataSharing planned: No. The prescription data will not be shared with the public. However, if the intervention is effective, the educational materials will be released to the public.
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.
Na Zhong, Doctor principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing waiting list and benzodiazepines related knowledge intervention in people with Bcenzodiazepines, Abuse, Retrospective Study, Focus Groups, Real-world Study, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of inappropriate BZDs and Z-drugs prescription (time frame: 3 months before and after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724669, which also lists 1 linked publication.
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 10 Mar 2022.