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Computer Stop Order Alert to Prevent Concurrent Prescribing of Trimethoprim/Sulfamethoxazole and Warfarin (warf-tmp/smx)

This study has been terminated.
(four adverse events encountered)
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00870298
First received: March 26, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Prescribers' Drug Orders
 Drug: Trimethoprim/Sulfamethoxazole and Warfarin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Randomized Controlled Study of a Computer Stop Order Versus Routine Practice When Trimethoprim/Sulfamethoxazole is Ordered Concurrently With Warfarin

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Reduce concomitant orders for warfarin and tmp/smx [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine if computerized stop order will increase risk for inadvertent cessation of warfarin [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1971
Study Start Date: August 2006
Study Completion Date: January 2007
Estimated Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: computerized alert
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
 Drug: Trimethoprim/Sulfamethoxazole and Warfarin
2 Current practice
Current practice of the pharmacist recommending cessation of concurrent warfarin and tmp/sulfa orders
 Drug: Trimethoprim/Sulfamethoxazole and Warfarin

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All resident physicians and nurse practitioners involved in inpatient care.

Exclusion Criteria:

None-

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Brian L. Strom, MD, MPH, UPenn
ClinicalTrials.gov Identifier: NCT00870298     History of Changes
Other Study ID Numbers: 803788
Study First Received: March 26, 2009
Last Updated: March 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
drug orders

Additional relevant MeSH terms:
Sulfamethoxazole
Trimethoprim
Warfarin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
 Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Hematologic Agents

ClinicalTrials.gov processed this record on May 23, 2013