title: Evaluation of a mobile electronic assistant to aid in fluindione prescription: the INRPlus cluster randomized trial.
abstract: BACKGROUND
  Regular monitoring of the international normalized ratio (INR) is crucial for dose adjustment of vitamin K antagonists (VKA) to maximize time in therapeutic range (TTR). We compared the use of a mobile electronic assistant INRPlus which proposes patient-specific fluindione doses, to standard fluindione management in a cluster randomized controlled study.
  
  
  METHODS
  Twenty clusters of six general practitioners were randomized to adjust fluindione doses in VKA-treated patients either using INRPlus or according to routine practice. TTR was measured over 6 months, along with time spent above or below the recommended INR range, frequency of measurements and related complications.
  
  
  RESULTS
  Of the 595 included patients, 551 were assessable (259 INRPlus, 292 control) and had a mean of 1.6 INR measurements/month. TTR was not significantly different between the two groups, 72.7% [Q1: 58.1%; Q3: 90%] in INRPlus patients and 71.2% [Q1: 54.8%; Q3: 88.2%] in control patients (p=0.445). At least 60% time within reference ranges was reported in 73.4% of INRPlus patients and 67.1% of control patients (relative risk 1.09, 95%CI 0.98-1.22, p=0.115). No significant differences were reported between the two groups for time outside reference ranges, frequency of measurements or complications. Eighty-two percent (82%) of patients complying with INRPlus-proposed doses spent more than 60% of TTR versus 66.9% of non-compliant patients and 67.1% of reference patients.
  
  
  CONCLUSIONS
  In this trial, the use of the INRPlus electronic assistant resulted in a non-significant improvement in TTR that may be due to a higher than expected TTR in the control group.
authors.affiliation: Collège National des Généralistes Enseignants (CNGE), Vincennes, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Imbert
authors.affiliation: Service de Médecine Vasculaire, Hôpital Michallon, CHU de Grenoble, France; Grenoble Alpes University, CNRS / TIMC-IMAG UMR 5525 / Themas, Grenoble, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Pernod
authors.affiliation: Collège National des Généralistes Enseignants (CNGE), Vincennes, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Jacquet
authors.affiliation: Merck Serono S.A.S, Lyon, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Bailly
authors.affiliation: Unité de Recherche Clinique, Innovation et Pharmacologie, CHU de Saint-Etienne, Université Jean Monnet, 42023 Saint-Etienne, France. Electronic address: silvy.laporte@chu-st-etienne.fr.
authors.forename: Silvy
authors.initials: S
authors.lastname: Laporte
authors.affiliation: UMR CNRS 5558/EMET site Laennec, Lyon, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Lievre
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage*; D034201:Computers, Handheld; D005260:Female; D058006:General Practice / Q000295:instrumentation* / Q000379:methods; D058005:General Practitioners; D006801:Humans; D019934:International Normalized Ratio / Q000295:instrumentation* / Q000379:methods; D008297:Male; D008875:Middle Aged; D010630:Phenindione / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies
chemical_list: D000925:Anticoagulants; D010630:Phenindione; C017673:fluindione
keywords: Electronic device; Fluindione; Vitamin K antagonist