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Improving Anticoagulation Control in VISN 1

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ClinicalTrials.gov Identifier: NCT01653405
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Anticoagulants Atrial Fibrillation Venous Thromboembolism Other: Multifaceted behavioral intervention Not Applicable

Detailed Description:

Background: Over 100,000 VA patients receive oral anticoagulation (AC) each year to prevent blood clots, including strokes. AC is safer and more effective when it is managed skillfully and therefore well-controlled. AC control can be measured using percent time in therapeutic range (TTR), the proportion of time when patients are sufficiently anticoagulated to prevent clots but not excessively anticoagulated (which increases the risk of bleeding). The investigators have shown that the anticoagulation clinics (ACCs) of the VA vary widely on TTR, from 40% (very poor control) to 70% (excellent control). Improving TTR in the VA would prevent thousands of adverse events, including strokes, major hemorrhages, and deaths. The investigators have further investigated the structures and processes of care that contribute to these wide disparities in TTR performance.

Objectives: We applied proven methods to change provider behavior. The goal was to facilitate the adoption of these evidence-based practices in order to improve TTR in VISN 1. We utilized educational outreach, audit and feedback, internal facilitation, and external facilitation to promote improvements in three evidence-based processes of care; namely, follow-up within 7 days after deranged INR values, minimizing loss to follow-up, and use of guideline concordant INR targets.

Methods: Our clinician-focused intervention used a Dashboard to measure site-level TTR and processes of care and an Algorithm for routine AC management. Both the Dashboard and the Algorithm are concrete representations of our main evidence-based recommendations to improve AC management. We promoted their use through quarterly visits to the sites, at which we delivered audit and feedback and educational outreach, and also provided external facilitation to address ways to improve these performance measures. Our main outcome was change in site TTR over time, which was compared between VISN 1 and non-VISN 1 sites using an interrupted time series. Secondary outcomes included site-level changes in processes of anticoagulation care (measured using automated data). We used a difference-in-differences (DID) model to examine changes in anticoagulation control, measured as percent time in target range (TTR), as well as process measures, and compared VISN 1 sites to 116 VA sites located outside VISN 1. The pre-intervention period was from 5/1/10-5/1/13, while the post-intervention period was from 5/2/13-5/10/16.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1260576 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Anticoagulation Control in VISN 1
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Intervention Group
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
The intervention included access to a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.

No Intervention: Control Group
VA patients treated at anticoagulation clinics at 116 sites outside of VISN 1.



Primary Outcome Measures :
  1. Percent Change in Time in Therapeutic Range (TTR) [ Time Frame: Baseline and 4 years ]
    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.


Secondary Outcome Measures :
  1. Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin [ Time Frame: Baseline and 4 years ]
    We compared the rate of 56-day gaps per patient year in the pre-intervention and post-intervention period. We used a difference in differences analysis to compare the intervention and control group. We are reporting absolute change.

  2. Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0) [ Time Frame: Baseline and 4 years ]
    We compared the percentage of patients with follow-up within 7 days before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups.

  3. Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower) [ Time Frame: Baseline and 4 years ]
    We compared the percentage of patients before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups. Absolute percentage is reported.

  4. Percentage of Patients With Mean INR Value Between 2.3 - 2.7 [ Time Frame: Baseline and 4 years ]
    We compared the absolute percentage of patients with a mean INR of 2.3 - 2.7 before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653405


Locations
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United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Ann M. Borzecki, MD MPH Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01653405     History of Changes
Other Study ID Numbers: SDP 12-249
First Posted: July 31, 2012    Key Record Dates
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Office of Research and Development:
anticoagulants
pharmacists
quality improvement
quality of health care
Additional relevant MeSH terms:
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Atrial Fibrillation
Thromboembolism
Venous Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases