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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
Anticoagulants
Atrial Fibrillation
Venous Thromboembolism
Behavioral: Outreach, Education, and Motivational Interviewing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Anticoagulation Control in VISN 1

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: October 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

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: 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653405

Locations
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Investigators
Principal Investigator: Adam J Rose, MD MSc Edith Nourse Rogers Memorial Veterans Hospital, Bedford
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01653405     History of Changes
Other Study ID Numbers: SDP 12-249
Study First Received: July 6, 2012
Last Updated: May 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
anticoagulants
pharmacists
quality improvement
quality of health care

Additional relevant MeSH terms:
Atrial Fibrillation
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on August 18, 2014