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Improving Anticoagulation Control in VISN 1
NA trial testing Multifaceted behavioral intervention in Anticoagulants in 1,260,576 participants. Completed in 30 September 2016.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 1,260,576 |
| Start date | 1 October 2014 |
| Primary completion | 30 September 2016 |
| Estimated completion | 30 September 2016 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
21 and older, any sex, with Anticoagulants or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 2.8 | |
| Control Group | 0.5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | -0.03 | ± 0.10 |
| Control Group | -0.01 | ± 0.09 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 15 | |
| Control Group | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 15 | |
| Control Group | 2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Group | 6 | |
| Control Group | 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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing