Enhancing the Safety of Warfarin in Nursing Homes

• ClinicalTrials.gov Identifier: NCT00682773
• Recruitment Status: Completed
• First Posted: May 22, 2008
• Last Update Posted: August 4, 2011
• Sponsor: University of Massachusetts, Worcester
• Collaborators: Agency for Healthcare Research and Quality (AHRQ); Qualidigm
• Information provided by: University of Massachusetts, Worcester

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	Phase
Adverse Drug Events (ADEs)	Other: SBAR	Not Applicable

  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
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: September 2009

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

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

Criteria

Inclusion Criteria:

• Connecticut nursing homes affiliated with Qualidigm

Exclusion Criteria:

• Nursing homes not affiliated with Qualidigm

Contacts and Locations

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

Agency for Healthcare Research and Quality (AHRQ)

Qualidigm

Investigators

• 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):

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.

• 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
• Last Update Posted: August 4, 2011
• Last Verified: August 2011

Additional relevant MeSH terms:

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Warfarin; Anticoagulants