- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01653405
Improving Anticoagulation Control in VISN 1
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Massachusetts
-
Bedford, Massachusetts, Vereinigte Staaten, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
The intervention included access to a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.
|
|
Kein Eingriff: Control Group
VA patients treated at anticoagulation clinics at 116 sites outside of VISN 1.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percent Change in Time in Therapeutic Range (TTR)
Zeitfenster: 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.
|
Baseline and 4 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin
Zeitfenster: 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.
|
Baseline and 4 years
|
|
Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0)
Zeitfenster: 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.
|
Baseline and 4 years
|
|
Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower)
Zeitfenster: 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.
|
Baseline and 4 years
|
|
Percentage of Patients With Mean INR Value Between 2.3 - 2.7
Zeitfenster: 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.
|
Baseline and 4 years
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Ann M. Borzecki, MD MPH, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- Rose 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SDP 12-249
Plan für individuelle Teilnehmerdaten (IPD)
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