We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Enhancing the Safety of Warfarin in Nursing Homes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00682773
Recruitment Status : Completed
First Posted : May 22, 2008
Last Update Posted : August 4, 2011
Information provided by:

Study Description
Brief Summary:
Oral anticoagulant therapy with warfarin is essential for the prevention of strokes and other thromboembolic events related to various medical conditions; however, use of this therapy can be associated with an increased risk of serious bleeding. In a previous AHRQ-funded study, we have demonstrated that the prevalence of conditions for which warfarin is indicated is high among frail elderly nursing homes residents, use of warfarin in this setting is very common, and the quality and safety with which warfarin is used is far from optimal. The research described in this application resonates with AHRQ's stated priorities for FY2006. The premise underlying the proposed intervention study is that errors in prescribing and monitoring warfarin for nursing home residents are related more to problems in the system of care, than to deficits in the knowledge base of health care providers. We propose a low technology intervention for improving the quality and safety of anticoagulant therapy with warfarin in the nursing home setting. The intervention focuses on maximizing the effectiveness of communication between the nursing staff and physicians of nursing home residents on warfarin. The intervention will build on an established approach for situation briefing drawn from the U.S. armed forces: SBAR - Situation, Background, Assessment, Recommendation. We will test the effectiveness of this approach through a matched, cluster-randomized trial, with randomization at the level of the nursing home. Our study has the following specific aims: (1) to determine whether a nursing home warfarin management protocol emphasizing facilitated communication to physicians will improve the quality of anticoagulation management, which will be assessed using widely accepted quality measures; (2) to determine whether the intervention will lower the rates of adverse events (bleeds and thromboembolic events) among warfarin-treated residents of intervention group nursing homes compared to control nursing homes; and (3) to produce a toolkit for use by nursing homes that will allow dissemination of this approach to enhancing the quality and safety of warfarin for the frail elderly. If successful, this approach may serve as a model for improving the safety of other medication categories associated with high rates of preventable adverse drug events, and for protecting nursing home residents, and frail elderly cared for in other settings, who are at special risk for medication-related problems.

Condition or disease Intervention/treatment
Adverse Drug Events (ADEs) Other: SBAR

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Enhancing the Safety of Warfarin in Nursing Homes
Study Start Date : September 2006
Primary Completion Date : December 2008
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
Usual care, no educational intervention.
Experimental: 2
Usual care, nursing home nursing staff receive educational intervention on effective communication regarding warfarin treatment/care; use of SBAR communication forms.
Other: SBAR
Educational intervention for nursing staff on effective communication regarding warfarin treatment/care; use of SBAR communication forms.

Outcome Measures

Primary Outcome Measures :
  1. The proportion of time that nursing home residents receiving warfarin have their international normalized ratios (INRs) within the target therapeutic range [ Time Frame: one year ]
  2. The time to next INR measurement after an out-of-range INR. [ Time Frame: one year ]
  3. Rates of adverse events (bleeds and thromboembolic events) [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Connecticut nursing homes affiliated with Qualidigm

Exclusion Criteria:

  • Nursing homes not affiliated with Qualidigm
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682773

United States, Connecticut
Middletown, Connecticut, United States, 06457
United States, Massachusetts
Meyers Primary Care Institute
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Jerry H Gurwitz, MD Meyers Primary Care Institute/University of Massachusetts Medical School
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jerry Gurwitz, MD, Executive Director, Meyers Primary Care Institute/University of Massachusetts Medical School
ClinicalTrials.gov Identifier: NCT00682773     History of Changes
Other Study ID Numbers: 12214
5R01HS016463 ( U.S. AHRQ Grant/Contract )
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders