Impact of an Atrial Fibrillation Decision Support Tool (AFDST) on Thromboprophylaxis for Atrial Fibrillation

Back to Search
Print
Bookmark Trial

NCT02524977

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Primary Care Practices of UC Health
Cincinnati, Ohio, 45267, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation, Atrial Flutter
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Study subjects were physicians in our primary care network.

- Patients included in the study were identified through our health system's clinical data store with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), diagnosis of atrial fibrillation (427.31) or atrial flutter (427.32)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Diagnoses of mitral valve disease (394.x), aortic valve disease (395.x), heart valve
transplant (V42.2) or heart valve replacement (V42.3).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Atrial Fibrillation, Atrial FlutterImpact of an Atrial Fibrillation Decision Support Tool (AFDST) on Thromboprophylaxis for Atrial Fibrillation
NCT02524977
  1. Cincinnati, Ohio
ALL GENDERS
0+
years
MULTIPLE SITES
Atrial Fibrillation, Atrial FlutterA Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
NCT04126486
  1. New Orleans, Louisiana
  2. Linden, New Jersey
  3. Everett, Washington
  4. Birmingham, Alabama
  5. Guntersville, Alabama
  6. Huntsville, Alabama
  7. Montgomery, Alabama
  8. Kingman, Arizona
  9. Peoria, Arizona
  10. Peoria, Arizona
  11. Phoenix, Arizona
  12. Phoenix, Arizona
  13. Yuma, Arizona
  14. Little Rock, Arkansas
  15. Canoga Park, California
  16. Fremont, California
  17. Fullerton, California
  18. Los Angeles, California
  19. Mission Viejo, California
  20. Oakland, California
  21. Palm Springs, California
  22. Sacramento, California
  23. Sacramento, California
  24. San Francisco, California
  25. Toluca Lake, California
  26. Aurora, Colorado
  27. Colorado Springs, Colorado
  28. Aventura, Florida
  29. Boynton Beach, Florida
  30. Clearwater, Florida
  31. Clearwater, Florida
  32. DeLand, Florida
  33. DeLand, Florida
  34. Doral, Florida
  35. Doral, Florida
  36. Doral, Florida
  37. Eustis, Florida
  38. Fort Lauderdale, Florida
  39. Fort Lauderdale, Florida
  40. Fort Lauderdale, Florida
  41. Fort Myers, Florida
  42. Hialeah, Florida
  43. Hialeah, Florida
  44. Hialeah, Florida
  45. Jacksonville, Florida
  46. Jacksonville, Florida
  47. Jacksonville, Florida
  48. Lake City, Florida
  49. Miami Beach, Florida
  50. Miami Lakes, Florida
  51. Miami Lakes, Florida
  52. Miami Shores, Florida
  53. Miami, Florida
  54. Miami, Florida
  55. Miami, Florida
  56. Miami, Florida
  57. Miami, Florida
  58. Miami, Florida
  59. Miami, Florida
  60. Miami, Florida
  61. Miami, Florida
  62. Mount Dora, Florida
  63. Oviedo, Florida
  64. Palm Harbor, Florida
  65. Palm Springs, Florida
  66. Sweetwater, Florida
  67. Tampa, Florida
  68. Tampa, Florida
  69. Weston, Florida
  70. Albany, Georgia
  71. Atlanta, Georgia
  72. Columbus, Georgia
  73. Eatonton, Georgia
  74. Fayetteville, Georgia
  75. Rincon, Georgia
  76. Sandy Springs, Georgia
  77. Savannah, Georgia
  78. Woodstock, Georgia
  79. Chicago, Illinois
  80. Evergreen Park, Illinois
  81. Gillespie, Illinois
  82. Wauconda, Illinois
  83. Indianapolis, Indiana
  84. Michigan City, Indiana
  85. Ames, Iowa
  86. Iowa City, Iowa
  87. Leawood, Kansas
  88. Wichita, Kansas
  89. Lexington, Kentucky
  90. Crowley, Louisiana
  91. Eunice, Louisiana
  92. Shreveport, Louisiana
  93. Zachary, Louisiana
  94. Annapolis, Maryland
  95. Baltimore, Maryland
  96. Elkridge, Maryland
  97. Hyattsville, Maryland
  98. Rockville, Maryland
  99. Boston, Massachusetts
  100. Boston, Massachusetts
  101. Boston, Massachusetts
  102. Haverhill, Massachusetts
  103. New Bedford, Massachusetts
  104. Worcester, Massachusetts
  105. Caro, Michigan
  106. Detroit, Michigan
  107. Sterling Heights, Michigan
  108. Troy, Michigan
  109. Minneapolis, Minnesota
  110. Amory, Mississippi
  111. Belzoni, Mississippi
  112. Jackson, Mississippi
  113. Petal, Mississippi
  114. Picayune, Mississippi
  115. Ridgeland, Mississippi
  116. Chesterfield, Missouri
  117. Florissant, Missouri
  118. Saint Louis, Missouri
  119. Norfolk, Nebraska
  120. Henderson, Nevada
  121. Las Vegas, Nevada
  122. Brooklyn, New York
  123. Cooperstown, New York
  124. East Syracuse, New York
  125. Endwell, New York
  126. North Massapequa, New York
  127. Black Mountain, North Carolina
  128. Burlington, North Carolina
  129. Cary, North Carolina
  130. Charlotte, North Carolina
  131. Charlotte, North Carolina
  132. Charlotte, North Carolina
  133. Durham, North Carolina
  134. Fayetteville, North Carolina
  135. Franklinton, North Carolina
  136. Greensboro, North Carolina
  137. Hickory, North Carolina
  138. Matthews, North Carolina
  139. Raleigh, North Carolina
  140. Raleigh, North Carolina
  141. Rocky Mount, North Carolina
  142. Salisbury, North Carolina
  143. Statesville, North Carolina
  144. Statesville, North Carolina
  145. Wilmington, North Carolina
  146. Winston-Salem, North Carolina
  147. Winston-Salem, North Carolina
  148. Cincinnati, Ohio
  149. Cincinnati, Ohio
  150. Cincinnati, Ohio
  151. Cleveland, Ohio
  152. Columbus, Ohio
  153. Dayton, Ohio
  154. Dayton, Ohio
  155. Norman, Oklahoma
  156. Danville, Pennsylvania
  157. Philadelphia, Pennsylvania
  158. Pittsburgh, Pennsylvania
  159. Pittsburgh, Pennsylvania
  160. Pittsburgh, Pennsylvania
  161. Uniontown, Pennsylvania
  162. Uniontown, Pennsylvania
  163. East Providence, Rhode Island
  164. Bristol, Tennessee
  165. Knoxville, Tennessee
  166. Morristown, Tennessee
  167. Nashville, Tennessee
  168. Allen, Texas
  169. Austin, Texas
  170. Austin, Texas
  171. Dallas, Texas
  172. Dallas, Texas
  173. Denton, Texas
  174. Edinburg, Texas
  175. Friendswood, Texas
  176. Georgetown, Texas
  177. Houston, Texas
  178. Houston, Texas
  179. Hurst, Texas
  180. Laredo, Texas
  181. Mesquite, Texas
  182. Pearland, Texas
  183. Pflugerville, Texas
  184. Pharr, Texas
  185. Plano, Texas
  186. Plano, Texas
  187. San Antonio, Texas
  188. San Antonio, Texas
  189. San Marcos, Texas
  190. Sugar Land, Texas
  191. Sugar Land, Texas
  192. Temple, Texas
  193. The Woodlands, Texas
  194. The Woodlands, Texas
  195. Tyler, Texas
  196. Bountiful, Utah
  197. Appomattox, Virginia
  198. Burke, Virginia
  199. Forest, Virginia
  200. Suffolk, Virginia
  201. Winchester, Virginia
  202. Winchester, Virginia
  203. Everett, Washington
  204. Tacoma, Washington
  205. Eau Claire, Wisconsin
  206. La Crosse, Wisconsin
  207. La Crosse, Wisconsin
  208. Madison, Wisconsin
ALL GENDERS
70 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Impact of an Atrial Fibrillation Decision Support Tool (AFDST) on Thromboprophylaxis for Atrial Fibrillation
Official Title  ICMJE Impact of a Quality Improvement And Education Initiative on 'Appropriate' Use of Anticoagulant Therapy in Patients With Atrial Fibrillation
Brief Summary Study objective was to improve decision-making and thromboprophylaxis for patients with Atrial Fibrillation (AF) by developing and implementing a computerized decision support tool for individual patient-level decision-making about oral anticoagulant therapy. To accomplish these goals, the investigators studied the incremental impact of adding a quality-improvement (QI) intervention to an educational package (for practice staff and clinicians) using a computerized aid, the Atrial Fibrillation Decision Support Tool (AFDST) for individual patient-level decision-making about oral anticoagulant therapy in patients with non-valvular AF. The decision support tool incorporates individual patients' risk factor profiles for ischemic stroke and bleeding and provides a recommendation for treatment based upon the projected quality-adjusted life expectancy gained or lost with the addition of either oral anticoagulant therapy or aspirin compared with no thromboprophylaxis.
Detailed Description

Setting - Cluster randomized trial. Setting - Primary care practices of an integrated healthcare system. Participants - 1,493 adults with non-valvular AF seen between April 2014 and March 2015.

Intervention - Treatment recommendations were made by an Atrial Fibrillation Decision Support Tool (AFDST) based on projections for quality-adjusted life expectancy calculated by a decision analytic model that integrates patient-specific risk factors for stroke and hemorrhage.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Atrial Fibrillation
  • Atrial Flutter
Intervention  ICMJE
  • Behavioral: Decision Support
    Provision of recommended antithrombotic therapy based on atrial fibrillation decision support tool that uses both stroke and bleeding risk
  • Behavioral: Educational Intervention Only
    Educational conference series
Study Arms  ICMJE
  • Active Comparator: Educational Intervention Only

    Educational Intervention Only - Educational package was delivered as 2 didactic noon-conferences on atrial fibrillation with a review of up-to-date anticoagulation guidelines for stroke prevention, and distribution of educational materials. Physicians delivering the noon conference series at all of the general internal medicine and primary care practice sites included 3 stroke neurologists, 2 cardiologists, and a general internist (PI) who were co-investigators in this study. Internists who were faculty at the University of Cincinnati and Internal Medicine residents also had an opportunity to participate in the first of the noon conferences in a special Department of Medicine Grand Rounds delivered by the PI.

    All practices (intervention and control groups) received the educational package focused on physicians, and clinical and non-clinical staff who would be involved in this QI process.

    Intervention: Behavioral: Educational Intervention Only
  • Experimental: Educational Intervention plus Decision Support
    Educational Intervention plus Decision Support - Physicians in the intervention arm received a practice-level and physician-level summary report via a secure web site designed for patients with treatment recommendations that were discordant with current therapy, along with an explanation for the recommendation, the gain or loss in QALYs predicted by the decision model and the current 2014 ACC/AHA/HRS guidelines. Providers were also reminded of upcoming visits for patients being seen within the next week so they could review their reports and use them in discussions with their patients.
    Interventions:
    • Behavioral: Decision Support
    • Behavioral: Educational Intervention Only
Publications * Eckman MH, Lip GY, Wise RE, Speer B, Sullivan M, Walker N, Kissela B, Flaherty ML, Kleindorfer D, Baker P, Ireton R, Hoskins D, Harnett BM, Aguilar C, Leonard AC, Arduser L, Steen D, Costea A, Kues J. Impact of an Atrial Fibrillation Decision Support Tool on thromboprophylaxis for atrial fibrillation. Am Heart J. 2016 Jun;176:17-27. doi: 10.1016/j.ahj.2016.02.009. Epub 2016 Feb 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2015)		70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Study subjects were physicians in our primary care network.
  • Patients included in the study were identified through our health system's clinical data store with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), diagnosis of atrial fibrillation (427.31) or atrial flutter (427.32)

Exclusion Criteria:

Diagnoses of mitral valve disease (394.x), aortic valve disease (395.x), heart valve transplant (V42.2) or heart valve replacement (V42.3).

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02524977
Other Study ID Numbers  ICMJE 2013-0017
1UL1TR001425-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Eckman, M.D., University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE
  • National Center for Advancing Translational Science (NCATS)
  • Pfizer
  • Bristol-Myers Squibb
Investigators  ICMJE Not Provided
PRS Account University of Cincinnati
Verification Date September 2018

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