AnticoagulantsNCT01653405
Improving Anticoagulation Control in VISN 1
A study testing Multifaceted behavioral intervention in people with Anticoagulants and Atrial Fibrillation, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Anticoagulants, Atrial Fibrillation, Venous Thromboembolism
- What is being tested?
- Multifaceted behavioral intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,260,576 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2014to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients receiving long-term oral anticoagulation with warfarin within the VA New England Region ("VISN 1")
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
About this study
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.
Read the 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.
- Conditions
- Anticoagulants, Atrial Fibrillation, Venous Thromboembolism
- Being tested
- Multifaceted behavioral intervention
- Keywords
- anticoagulants, pharmacists, quality improvement, quality of health care
- Medical subject headings
- Atrial Fibrillation, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted behavioral interventionOther
The intervention included access to a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multifaceted behavioral intervention |
| Control Group | No intervention | VA patients treated at anticoagulation clinics at 116 sites outside of VISN 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 years
Secondary outcomes (4)
Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin
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.
Measured: Baseline and 4 years
Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0)
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.
Measured: Baseline and 4 years
Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower)
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.
Measured: Baseline and 4 years
Percentage of Patients With Mean INR Value Between 2.3 - 2.7
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.
Measured: Baseline and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study start1 Oct 2014
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnticoagulantsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,260,576 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ann M. Borzecki, MD MPH, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653405
- Sponsor's protocol ID
- SDP 12-249
- Status last verified
- Jan 2019
- First submitted
- 6 Jul 2012
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27349472Rose 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.
PubMed 28367699
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Anticoagulation Control in VISN 1
- ClinicalTrials.gov ID
- NCT01653405
- Acronym / sponsor ID
- SDP 12-249
- Conditions
- Anticoagulants, Atrial Fibrillation, Venous Thromboembolism
- Keywords
- anticoagulants, pharmacists, quality improvement, quality of health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,260,576 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Multifaceted behavioral interventionVA 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. |
| Control Group | No intervention | –VA patients treated at anticoagulation clinics at 116 sites outside of VISN 1. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients receiving long-term oral anticoagulation with warfarin within the VA New England Region ("VISN 1")
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted behavioral interventionThe intervention included access to a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback. | Other | Intervention Group |
Primary outcome
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.
4 secondary outcomes
Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin
Time frame: Baseline and 4 years
Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0)
Time frame: Baseline and 4 years
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
Percentage of Patients With Mean INR Value Between 2.3 - 2.7
Time frame: Baseline and 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27349472Rose 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.
- Results publication: PubMed 28367699Rose 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M. Borzecki, MD MPH principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted behavioral intervention in people with Anticoagulants and Atrial Fibrillation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Time in Therapeutic Range (TTR) (time frame: Baseline and 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01653405, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.