Warfarin and NSAIDNCT00880932
Warfarin and Non-Steroidal Anti-Inflammatory Drugs (NSAID) Customized Alert
A study testing Electronic Alert in people with Warfarin and NSAID, run by University of Pennsylvania at 1 site in United States.
Trial summary
The hypothesis is that a newly formatted electronic alert that requires the prescriber to pause and enter a specific "reason for override" on this alert, will cause prescribers in the intervention group to be significantly less likely to prescribe the combination of warfarin and NSAID than prescribers in the control… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Warfarin and NSAID
- What is being tested?
- Electronic Alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,865 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2007
- 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
- Child, Adult, Older adult
Who may be able to join
- All resident physicians (RP) and nurse practitioners (NP) involved in inpatient care at two hospitals of the University of Pennsylvania
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effect of Customized Alerts Versus Generic Alerts for the Prescription of Warfarin and NSAID
The hypothesis is that a newly formatted electronic alert that requires the prescriber to pause and enter a specific "reason for override" on this alert, will cause prescribers in the intervention group to be significantly less likely to prescribe the combination of warfarin and NSAID than prescribers in the control group.
- Conditions
- Warfarin and NSAID
- Being tested
- Electronic Alert
- Keywords
- warfarin, NSAID, The condition is the concomitant prescription of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic AlertBehavioural
| Study group | Role | What they receive |
|---|---|---|
| customized electronic alert | Experimental | This intervention was not targeted to patients with a disease but to the providers. The intervention was not a drug but a customized electronic alert, requesting the prescriber to specify a "reason for override" whenever the combination drugs of warfarin and NSAID were ordered together. Receives: Behavioral: Electronic Alert |
| Standard practice | No intervention | The control group was not patients but the providers. Providers in the control group continued with the standard practice of receiving passive alerts in the form of message boxes warning the provider not to prescribe the combination drugs warfarin and NSAID. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased rate of prescription of the combination of warfarin and NSAID
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startAug 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Warfarin and NSAIDStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,865 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880932
- Sponsor's protocol ID
- 803787
- Status last verified
- Apr 2009
- First submitted
- 13 Apr 2009
- Last updated
- 14 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Customized Alerts Versus Generic Alerts for the Prescription of Warfarin and NSAID
- ClinicalTrials.gov ID
- NCT00880932
- Acronym / sponsor ID
- 803787
- Conditions
- Warfarin and NSAID
- Keywords
- warfarin, NSAID, The condition is the concomitant prescription of
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,865 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Apr 2009 (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 hypothesis is that a newly formatted electronic alert that requires the prescriber to pause and enter a specific "reason for override" on this alert, will cause prescribers in the intervention group to be significantly less likely to prescribe the combination of warfarin and NSAID than prescribers in the control group.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| customized electronic alert | Experimental | Behavioral: Electronic AlertThis intervention was not targeted to patients with a disease but to the providers. The intervention was not a drug but a customized electronic alert, requesting the prescriber to specify a "reason for override" whenever the combination drugs of warfarin and NSAID were ordered together. |
| Standard practice | No intervention | –The control group was not patients but the providers. Providers in the control group continued with the standard practice of receiving passive alerts in the form of message boxes warning the provider not to prescribe the combination drugs warfarin and NSAID. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All resident physicians (RP) and nurse practitioners (NP) involved in inpatient care at two hospitals of the University of Pennsylvania
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Electronic Alert | Behavioural | customized electronic alert |
Primary outcome
Decreased rate of prescription of the combination of warfarin and NSAID
Time frame: 17 months
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 14 Apr 2009.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Alert in people with Warfarin and NSAID, run by University of Pennsylvania at 1 site in United States.
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 1 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 14 Apr 2009. 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 United States. 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.
What does the primary outcome measure?
Decreased rate of prescription of the combination of warfarin and NSAID (time frame: 17 months). 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 14 Apr 2009.