Prescribers' Drug Orderswarf-tmp/smxNCT00870298
Computer Stop Order Alert to Prevent Concurrent Prescribing of Trimethoprim/Sulfamethoxazole and Warfarin
A study testing Trimethoprim/Sulfamethoxazole and Warfarin in people with Prescribers' Drug Orders, run by University of Pennsylvania.
Trial summary
To determine if a computerized stop order will reduce the number of concurrent trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic ordering system while a patient is hospitalized. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prescribers' Drug Orders
- What is being tested?
- Trimethoprim/Sulfamethoxazole and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,971 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Jan 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All resident physicians and nurse practitioners involved in inpatient care.
Who cannot join
- None-
About this study
Official title: Randomized Controlled Study of a Computer Stop Order Versus Routine Practice When Trimethoprim/Sulfamethoxazole is Ordered Concurrently With Warfarin
To determine if a computerized stop order will reduce the number of concurrent trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic ordering system while a patient is hospitalized.
- Conditions
- Prescribers' Drug Orders
- Being tested
- Trimethoprim/Sulfamethoxazole and Warfarin
- Keywords
- drug orders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim/Sulfamethoxazole and WarfarinDrug
| Study group | Role | What they receive |
|---|---|---|
| computerized alert | Experimental | An automatic electronic stop of the tmp/sulfa or warfarin order whenever a resident or nurse practitioner places an order for tmp/sulfa with an already active warfarin order, or when ordering both simultaneously Receives: Drug: Trimethoprim/Sulfamethoxazole and Warfarin |
| 2 Current practice | Other | Current practice of the pharmacist recommending cessation of concurrent warfarin and tmp/sulfa orders Receives: Drug: Trimethoprim/Sulfamethoxazole and Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce concomitant orders for warfarin and tmp/smx
Measured: 7 months
Secondary outcomes (2)
Determine if computerized stop order will increase risk for inadvertent cessation of warfarin
Measured: 7 months
Determine if computerized stop order will increase risk of delay of treatment with tmp/sulfa when determined to be necessary for treatment
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startAug 2006
- Primary completionJan 2007
- Study completionJan 2007
Why it stopped: four adverse events encountered
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 Prescribers' Drug OrdersStudies 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
- Participant
- Enrolment
- 1,971 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870298
- Sponsor's protocol ID
- 803788
- Acronym
- warf-tmp/smx
- Status last verified
- Dec 2015
- First submitted
- 26 Mar 2009
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Strom BL, Schinnar R, Aberra F, Bilker W, Hennessy S, Leonard CE, Pifer E. Unintended effects of a computerized physician order entry nearly hard-stop alert to prevent a drug interaction: a randomized controlled trial. Arch Intern Med. 2010 Sep 27;170(17):1578-83. doi: 10.1001/archinternmed.2010.324.
PubMed 20876410
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of a Computer Stop Order Versus Routine Practice When Trimethoprim/Sulfamethoxazole is Ordered Concurrently With Warfarin
- ClinicalTrials.gov ID
- NCT00870298
- Acronym / sponsor ID
- warf-tmp/smx / 803788
- Conditions
- Prescribers' Drug Orders
- Keywords
- drug orders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: four adverse events encountered
- Enrolment
- 1,971 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 27 Mar 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.
To determine if a computerized stop order will reduce the number of concurrent trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic ordering system while a patient is hospitalized.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computerized alert | Experimental | Drug: Trimethoprim/Sulfamethoxazole and WarfarinAn automatic electronic stop of the tmp/sulfa or warfarin order whenever a resident or nurse practitioner places an order for tmp/sulfa with an already active warfarin order, or when ordering both simultaneously |
| 2 Current practice | Other | Drug: Trimethoprim/Sulfamethoxazole and WarfarinCurrent practice of the pharmacist recommending cessation of concurrent warfarin and tmp/sulfa orders |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All resident physicians and nurse practitioners involved in inpatient care.
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 |
|---|---|---|
| Trimethoprim/Sulfamethoxazole and Warfarin | Drug | 2 Current practice, computerized alert |
Primary outcome
Reduce concomitant orders for warfarin and tmp/smx
Time frame: 7 months
2 secondary outcomes
Determine if computerized stop order will increase risk for inadvertent cessation of warfarin
Time frame: 7 months
Determine if computerized stop order will increase risk of delay of treatment with tmp/sulfa when determined to be necessary for treatment
Time frame: 7 months
Results and safety
The study was stopped early (reason given: four adverse events encountered). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Derived from this study: PubMed 20876410Strom BL, Schinnar R, Aberra F, Bilker W, Hennessy S, Leonard CE, Pifer E. Unintended effects of a computerized physician order entry nearly hard-stop alert to prevent a drug interaction: a randomized controlled trial. Arch Intern Med. 2010 Sep 27;170(17):1578-83. doi: 10.1001/archinternmed.2010.324.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Trimethoprim/Sulfamethoxazole and Warfarin in people with Prescribers' Drug Orders, run by University of Pennsylvania.
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: stopped early, as of the sponsor's last update on 9 Dec 2015. 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?
The study was stopped early (reason given: four adverse events encountered). Results are not available in the source record.
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?
Reduce concomitant orders for warfarin and tmp/smx (time frame: 7 months). 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 NCT00870298, 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 9 Dec 2015.