Enhancing the Safety of Warfarin in Nursing Homes
2 other identifiers
interventional
26
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2006
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 20, 2008
CompletedFirst Posted
Study publicly available on registry
May 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedAugust 4, 2011
August 1, 2011
2.3 years
May 20, 2008
August 2, 2011
Conditions
Outcome Measures
Primary Outcomes (3)
The proportion of time that nursing home residents receiving warfarin have their international normalized ratios (INRs) within the target therapeutic range
one year
The time to next INR measurement after an out-of-range INR.
one year
Rates of adverse events (bleeds and thromboembolic events)
one year
Study Arms (2)
1
NO INTERVENTIONUsual care, no educational intervention.
2
EXPERIMENTALUsual care, nursing home nursing staff receive educational intervention on effective communication regarding warfarin treatment/care; use of SBAR communication forms.
Interventions
Educational intervention for nursing staff on effective communication regarding warfarin treatment/care; use of SBAR communication forms.
Eligibility Criteria
You may qualify if:
- Connecticut nursing homes affiliated with Qualidigm
You may not qualify if:
- Nursing homes not affiliated with Qualidigm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Massachusetts, Worcesterlead
- Agency for Healthcare Research and Quality (AHRQ)collaborator
- Qualidigmcollaborator
Study Sites (2)
Qualidigm
Middletown, Connecticut, 06457, United States
Meyers Primary Care Institute
Worcester, Massachusetts, 01605, United States
Related Publications (1)
Field TS, Tjia J, Mazor KM, Donovan JL, Kanaan AO, Harrold LR, Reed G, Doherty P, Spenard A, Gurwitz JH. Randomized trial of a warfarin communication protocol for nursing homes: an SBAR-based approach. Am J Med. 2011 Feb;124(2):179.e1-7. doi: 10.1016/j.amjmed.2010.09.017.
PMID: 21295198DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry H Gurwitz, MD
Meyers Primary Care Institute/University of Massachusetts Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 20, 2008
First Posted
May 22, 2008
Study Start
September 1, 2006
Primary Completion
December 1, 2008
Study Completion
September 1, 2009
Last Updated
August 4, 2011
Record last verified: 2011-08