Enhancing the Safety of Warfarin in Nursing Homes

NCT00682773 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2011-08-04

No results posted yet for this study

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.

Conditions

  • Adverse Drug Events (ADEs)

Interventions

OTHER

SBAR

Educational intervention for nursing staff on effective communication regarding warfarin treatment/care; use of SBAR communication forms.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED
  • Qualidigm

    collaborator INDUSTRY
  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Jerry H Gurwitz, MD · Meyers Primary Care Institute/University of Massachusetts Medical School

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-12-31
Completion
2009-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00682773 on ClinicalTrials.gov