Improving Anticoagulation Control in VISN 1

NCT01653405 | Completed Results

• 1 other identifier: SDP 12-249
• Study Type: interventional
• Target: 1,260,576
• Locations: 1 country
• Sites: 1

Brief Summary

Over 100,000 VHA patients receive anticoagulants (blood thinners) each year to prevent blood clots (including strokes). Too much anticoagulation increases the risk of serious or even fatal bleeding, and too little anticoagulation fails to protect the patient against blood clots. VHA anticoagulation clinics vary widely on how much time their patients spend in the therapeutic range, the range within which they are protected from clots but not at excessive risk of bleeding. Anticoagulation clinics can improve anticoagulation control by following several relatively simple procedures, including following-up promptly when patients are out of range and focusing on educating and supporting patients with poor control. In this study, the investigators will promote these practices at the anticoagulation clinics of the New England VA region, with a goal of improving anticoagulation control.

Conditions

Anticoagulants; Atrial Fibrillation; Venous Thromboembolism

Keywords

anticoagulants; pharmacists; quality improvement; quality of health care

Outcome Measures

Primary Outcomes (1)

• Percent Change in Time in Therapeutic Range (TTR)

  We compared TTR after the intervention to before the intervention. We used a difference in differences analysis to compare the absolute percentage change over time in the intervention group vs. the control group.

  Baseline and 4 years

Secondary Outcomes (4)

• Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin

  Baseline and 4 years

• Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0)

  Baseline and 4 years

• Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower)

  Baseline and 4 years

• Percentage of Patients With Mean INR Value Between 2.3 - 2.7

  Baseline and 4 years

Study Arms (2)

Intervention Group

EXPERIMENTAL

VA patients treated at anticoagulation clinics at 8 sites in VISN 1. The intervention included a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.

Other: Multifaceted behavioral intervention

Control Group

NO INTERVENTION

VA patients treated at anticoagulation clinics at 116 sites outside of VISN 1.

Interventions

Multifaceted behavioral intervention OTHER

The intervention included access to a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.

Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients receiving long-term oral anticoagulation with warfarin within the VA New England Region ("VISN 1")

You may not qualify if:

• Patients with valvular heart disease, who may have an INR target range other than 2-3. This usually represents between 10-15% of patients receiving anticoagulation.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

Related Publications (2)

• Rose AJ, McCullough MB. A Practical Guide to Using the Positive Deviance Method in Health Services Research. Health Serv Res. 2017 Jun;52(3):1207-1222. doi: 10.1111/1475-6773.12524. Epub 2016 Jun 28.

  PMID: 27349472 RESULT

• Rose AJ, Park A, Gillespie C, Van Deusen Lukas C, Ozonoff A, Petrakis BA, Reisman JI, Borzecki AM, Benedict AJ, Lukesh WN, Schmoke TJ, Jones EA, Morreale AP, Ourth HL, Schlosser JE, Mayo-Smith MF, Allen AL, Witt DM, Helfrich CD, McCullough MB. Results of a Regional Effort to Improve Warfarin Management. Ann Pharmacother. 2017 May;51(5):373-379. doi: 10.1177/1060028016681030. Epub 2016 Dec 17.

  PMID: 28367699 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases

Results Point of Contact

• Title: Dr. Adam Rose
• Organization: Rand Corporation

arose@rand.org

617-338-2059

Study Officials

• Ann M. Borzecki, MD MPH

  Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 31, 2012
• Study Start: October 1, 2014
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)