Enhancing the Safety of Warfarin in Nursing Homes

This study has been completed.
Sponsor:
Collaborators:
Qualidigm
Information provided by:
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00682773
First received: May 20, 2008
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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 Intervention
Adverse Drug Events (ADEs)
Other: SBAR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Enhancing the Safety of Warfarin in Nursing Homes

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • The time to next INR measurement after an out-of-range INR. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Rates of adverse events (bleeds and thromboembolic events) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: September 2006
Study Completion Date: September 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Connecticut nursing homes affiliated with Qualidigm

Exclusion Criteria:

  • Nursing homes not affiliated with Qualidigm
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682773

Locations
United States, Connecticut
Qualidigm
Middletown, Connecticut, United States, 06457
United States, Massachusetts
Meyers Primary Care Institute
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
Qualidigm
Investigators
Principal Investigator: Jerry H Gurwitz, MD Meyers Primary Care Institute/University of Massachusetts Medical School
  More Information

No publications provided by University of Massachusetts, Worcester

Additional 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
Study First Received: May 20, 2008
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Drug Toxicity
Poisoning
Substance-Related Disorders
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014