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
|Condition or disease||Intervention/treatment||Phase|
|Anticoagulants Atrial Fibrillation Venous Thromboembolism||Other: Multifaceted behavioral intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1260576 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653405
|United States, Massachusetts|
|Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA|
|Bedford, Massachusetts, United States, 01730|
|Principal Investigator:||Ann M. Borzecki, MD MPH||Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA|