Improving Anticoagulation Control in VISN 1

This study has been withdrawn prior to enrollment.
(Study design changed, no longer an experimental design.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01653405
First received: July 6, 2012
Last updated: May 9, 2014
Last verified: May 2014

July 6, 2012
May 9, 2014
October 2014
September 2016   (final data collection date for primary outcome measure)
Percent time in therapeutic range [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Percent time in therapeutic INR range (TTR) is a summary measure of anticoagulation control over time. TTR will be measured in 6 month intervals at the level of the individual patient and also aggregated at the site level.
Same as current
Complete list of historical versions of study NCT01653405 on ClinicalTrials.gov Archive Site
  • Rate of 56-day gaps in monitoring per patient-year among patients receiving anticoagulation with warfarin [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Gaps in INR monitoring have been associated with poor control and outcomes. We will be measuring the rate of such gaps at the level of the individual patient and also aggregated at the site level.
  • Days until follow-up after a high INR value (>4.0) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    A prolonged interval until the next INR test after a high INR has been associated with poor control and outcomes. We will be measuring the number of days until the next INR value after a high INR at the individual patient and also aggregated at the site level.
  • Days until follow-up after a low INR value (1.5 or lower) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    A prolonged interval until the next INR test after a low INR has been associated with poor control and outcomes. We will be measuring the number of days until the next INR value after a low INR at the individual patient and also aggregated at the site level.
  • Mean INR value among patients with an INR target of 2-3 [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Mean INR value is a proxy measure for the actual target range that was used. If the clinician is truly attempting to achieve an INR of 2.5, then the mean INR should be very close to that over time, although individual values may be higher or lower. A mean INR value below 2.3 or above 2.7 is associated with poor anticoagulation control. We will be measuring the mean INR value at the individual patient and also aggregated at the site level.
Same as current
Not Provided
Not Provided
 
Improving Anticoagulation Control in VISN 1
Improving Anticoagulation Control in VISN 1

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.

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: In this proposed study, the investigators will apply proven methods to change provider behavior and improve patient adherence and self-management. The goal will be to facilitate the adoption of these evidence-based practices in order to improve TTR in VISN 1. The investigators will accomplish this through a two-part intervention: 1) A clinician-focused intervention will utilize educational outreach, audit and feedback, internal facilitation, and external facilitation to promote improvements in four evidence-based processes of care. 2) A patient-focused intervention will utilize outreach, a group educational seminar, and motivational interviewing to educate patients with poor baseline anticoagulation control and promote behavior change.

Methods: The clinician-focused intervention will use 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. The investigators will promote their use through quarterly visits to the sites, which will include audit and feedback and educational outreach, and also provide external facilitation to address ways to improve these performance measures. The patient-level intervention will be delivered to the 25% of VISN patients with low TTR at baseline (<50%). ACC staff will identify such patients using the Dashboard, and will send them an outreach letter inviting them to attend a brief educational seminar. All intervention patients, whether or not they attended the seminar, will receive follow-up management including motivational interviewing (MI) to address behavior change. The main outcome for Aim 1 is change in site TTR over time, which will be compared between VISN 1 and non-VISN 1 sites using an interrupted time series. The main outcome for Aim 2 is change in patient-level TTR, for which intervention and control patients will be compared using a regression discontinuity analysis. Secondary outcomes will include site-level changes in processes of anticoagulation care (measured using automated data), costs and cost savings, and sustainability of changes over time.

Anticipated Impact: The goal of this project is to increase TTR in VISN 1 to 75%, far higher than any other VISN. Such improvement in TTR is associated with greatly reduced rates of adverse events for patients. Improved TTR will save more money than our intervention will cost, in large part because of efficiencies of management and less-frequent follow-up for better controlled patients. At the conclusion of this regional project, the investigators will promote the spread of these interventions throughout the VHA.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Anticoagulants
  • Atrial Fibrillation
  • Venous Thromboembolism
Behavioral: Outreach, Education, and Motivational Interviewing
Patients in the bottom 25% of TTR at baseline will receive an outreach message delivered at a routine care visit. The outreach message will inform them that their control is poor and this puts them at risk for bad outcomes. They will be offered an invitation to attend an education session to learn more about how to self-manage warfarin therapy. This session will be delivered by local clinical staff, using materials that we will provide. Finally, we will educate local clinical staff in the use of motivational interviewing (MI) and will provide a manual to help them deliver MI-based care. They will be asked to deliver MI-based care specifically to patients in the intervention group.
  • No Intervention: Control Group
    Patients in the top 75% of TTR at baseline
  • Experimental: Intervention Group
    Patients in the bottom 25% of TTR at baseline
    Intervention: Behavioral: Outreach, Education, and Motivational Interviewing
Rose AJ. Warfarin: not dead yet. J Gen Intern Med. 2014 Mar;29(3):425-6. doi: 10.1007/s11606-013-2708-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2016
September 2016   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01653405
SDP 12-249
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Adam J Rose, MD MSc Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Department of Veterans Affairs
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP