title: Implementation of the Department of Veterans Affairs' first point-of-care clinical trial.
abstract: OBJECTIVE
  The Massachusetts Veterans Epidemiology Research and Information Center in collaboration with the Stanford Center for Innovative Study Design set out to test the feasibility of a new method of evidence generation. The first pilot of a point-of-care clinical trial (POCCT), adding randomization and other study processes to an electronic medical record (EMR) system, was launched to compare the effectiveness of two insulin regimens.
  
  
  METHODS
  Existing functionalities of the Veterans Affairs (VA) computerized patient record system (CPRS)/veterans health information systems and technology architecture (VISTA) were modified to support the activities of a randomized controlled trial including enrolment, randomization, and longitudinal data collection.
  
  
  RESULTS
  The VA's CPRS/VISTA was successfully adapted to support the processes of a clinical trial and longitudinal study data are being collected from the medical record automatically. As of 30 June 2011, 55 of the 67 eligible patients approached received a randomized intervention.
  
  
  CONCLUSIONS
  The design of CPRS/VISTA made integration of study workflows and data collection possible. Institutions and investigators considering similar designs must carefully map clinical workflows and clinical trial workflows to EMR capabilities. POCCT study teams are necessarily interdisciplinary and interdepartmental. As a result, executive sponsorship is critical.
  
  
  CONCLUSIONS
  POCCT represent a promising new method for conducting clinical science. Much work is needed to understand better the optimal uses and designs for this new approach. Next steps include focus groups to measure patient and clinician perceptions, multisite deployment of the current pilot, and implementation of additional studies.
authors.affiliation: Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), Cooperative Studies Coordinating Center, VA Boston Healthcare System, Jamaica Plain, Massachusetts 02130, USA. leonard.davolio@va.gov
authors.forename: Leonard
authors.initials: L
authors.lastname: D'Avolio
authors.forename: Ryan
authors.initials: R
authors.lastname: Ferguson
authors.forename: Sergey
authors.initials: S
authors.lastname: Goryachev
authors.forename: Patricia
authors.initials: P
authors.lastname: Woods
authors.forename: Thomas
authors.initials: T
authors.lastname: Sabin
authors.forename: Joseph
authors.initials: J
authors.lastname: O'Neil
authors.forename: Chester
authors.initials: C
authors.lastname: Conrad
authors.forename: Joseph
authors.initials: J
authors.lastname: Gillon
authors.forename: Jasmine
authors.initials: J
authors.lastname: Escalera
authors.forename: Mary
authors.initials: M
authors.lastname: Brophy
authors.forename: Phillip
authors.initials: P
authors.lastname: Lavori
authors.forename: Louis
authors.initials: L
authors.lastname: Fiore
mesh_terms: D001499:Bayes Theorem; D057186:Comparative Effectiveness Research; D003920:Diabetes Mellitus / Q000188:drug therapy*; D006801:Humans; D007328:Insulin / Q000008:administration & dosage*; D050316:Medical Order Entry Systems; D016347:Medical Records Systems, Computerized; D018579:Patient Selection; D010865:Pilot Projects; D019095:Point-of-Care Systems; D012107:Research Design; D014481:United States; D014493:United States Department of Veterans Affairs; D057188:Workflow
chemical_list: D007328:Insulin