Drug Interaction AlertNCT01280422
Analysis of Drug-drug Interaction Alert Based on Multicenter Clinical Database
An observational study of Drug Interaction Alert, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The doctor's overridden rate for Drug-drug interaction (DDI) alert systems was 85-95% in foreign and there was more than 90% overridden rate in Taiwan. Why DDI alerts systems which spent much time and money to establish could not use medicinal information to increase drug safety? One of the reasons which induced to… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Drug Interaction Alert
- How many people
- 67,128,927 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2010to Aug 2010
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients
Who may be able to join
- Select DDI rules: antacids and antibiotics
- Database: ROCDR (multicenter clinical database)
- The pharmacists defined six rules which were based on medical knowledge for true alerts or false-alert.
- True alert: Rule 1 and Rule 2
- "False-alert": Rule 3 or Rule 4
- "Other" (Unable to determine): Rule 5 or Rule 6
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
The doctor's overridden rate for Drug-drug interaction (DDI) alert systems was 85-95% in foreign and there was more than 90% overridden rate in Taiwan. Why DDI alerts systems which spent much time and money to establish could not use medicinal information to increase drug safety? One of the reasons which induced to override was that health care thought there were too much DDI alerts and high false alerts.
The difference between DDI alert systems from pharmacists to confirm drug-drug interaction was that pharmacists not only confirmed ordering drug at the same time but also checked the other drug information such as frequency, rote and refill etc. Therefore, DDI alert systems which were established by drug code alone would induce a lot of false alerts.
In order to study how much false alert rate in drug-drug interactions, this research selected most common drug-drug interaction which was antacids and antibiotics. Antacids were most self-payment so this research needed to analyze ROCDR (Establishing a Multi-Center, Longitudinal, Research-Oriented Clinical Data Repository for Clinical Research). The aim was to study how many drug-drug interactions and false alerts from antacids and antibiotics and analyze the difference in different department. Finally, proposing advice and assessment for building drug-drug interaction alerts system to strength drug information system and increase drug safety.
- Conditions
- Drug Interaction Alert
- Keywords
- ROCDR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startFeb 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Interaction AlertStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 67,128,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yu-Chuan Li, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280422
- Sponsor's protocol ID
- 99009
- Status last verified
- Jan 2011
- First submitted
- 19 Jan 2011
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Drug-drug Interaction Alert Based on Multicenter Clinical Database
- ClinicalTrials.gov ID
- NCT01280422
- Acronym / sponsor ID
- 99009
- Conditions
- Drug Interaction Alert
- Keywords
- ROCDR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67,128,927 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Study completion
- Aug 2010 (actual)
- First posted
- 20 Jan 2011 (estimated)
- 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.
The doctor's overridden rate for Drug-drug interaction (DDI) alert systems was 85-95% in foreign and there was more than 90% overridden rate in Taiwan. Why DDI alerts systems which spent much time and money to establish could not use medicinal information to increase drug safety? One of the reasons which induced to override was that health care thought there were too much DDI alerts and high false alerts.
The difference between DDI alert systems from pharmacists to confirm drug-drug interaction was that pharmacists not only confirmed ordering drug at the same time but also checked the other drug information such as frequency, rote and refill etc. Therefore, DDI alert systems which were established by drug code alone would induce a lot of false alerts.
In order to study how much false alert rate in drug-drug interactions, this research selected most common drug-drug interaction which was antacids and antibiotics. Antacids were most self-payment so this research needed to analyze ROCDR (Establishing a Multi-Center, Longitudinal, Research-Oriented Clinical Data Repository for Clinical Research). The aim was to study how many drug-drug interactions and false alerts from antacids and antibiotics and analyze the difference in different department. Finally, proposing advice and assessment for building drug-drug interaction alerts system to strength drug information system and increase drug safety.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients
Key inclusion criteria (6 listed)
- Select DDI rules: antacids and antibiotics
- Database: ROCDR (multicenter clinical database)
- The pharmacists defined six rules which were based on medical knowledge for true alerts or false-alert.
Key exclusion criteria (1 listed)
- N/A
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
Not reported in the source record.
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 20 Jan 2011.
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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.
Yu-Chuan Li principal investigator
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Interaction Alert, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 6 inclusion and 1 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 20 Jan 2011. 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 Taiwan. 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. 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.
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 20 Jan 2011.