Anticoagulation: primary-care based management was as safe and effective as hospital-based management.

Clinical bottom line (level 1b)

  1. Patients on anticoagulation who were treated in primary care using near-patient testing and computer decision-support compared with hospital care were not clearly less likely to die or have a serious adverse event
  2. Patients in both groups spent a similar percentage of time with an INR within the therapeutic range.
Fitzmaurice et al: Archives of Internal Medicine 2000; 160 : 2343-2348
Expires October 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 12 general practices, Birmingham, UK - 3 used as controls

376 patients (aged , 55% male) requiring anticoagulation (48% for atrial fibrillation)

Excluded if
  • aged < 18

Control Group: (n = 245, 245 analysed): usual hospital-based care
Experimental Group: (n = 122, 122 analysed): practice-based care by nurses using near-patient testing and computerised decision support systems. Nurses checked with primary-care physicians if a dose change or a break in treatment was suggested.
Patients started on warfarin were stablised in a hospital clinic before randomisation.
100% followed for 12 months
Outcome notes:

  • serious adverse event : stroke, epistaxis, venous thromboembolic event

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
death 12 months 6
(2.45%)		 3
(2.46%)		 0%
(-300% to 74%)		 -0.01%
(-3.37% to 3.35%)		 -9900
(NNT = 30 to infinity;
NNH = 30 to infinity)
serious adverse event 12 months 10
(4.08%)		 3
(2.46%)		 40%
(-120% to 83%)		 1.62%
(-2.08% to 5.32%)		 62
(NNT = 19 to infinity;
NNH = 48 to infinity)

  • Primary-care based patients spent 69% (95% CI: 66% to 73%) of the time within the set therapeutic range. Hospital based patients spent 62% (95% CI: 54% to 70%) of the time within the set range.

Comments

  1. The study was too small to show any difference between the two groups for mortality or adverse events.

Citation

  1. Fitzmaurice DA, Hobbs FD, Murray ET, et al: oral anticoagulation management in primary care with the use of computerized decision support and near-patient testing: a randomized controlled trial. Archives of Internal Medicine 2000; 160 : 2343-2348
Search Terms: from EBM journal
Contributor: Chris Ball, October 2001
Reviewer: Clare Wotton

Clinical Question.
Patient anticoagulation
Intervention or Exposure primary-care management
Comparison hospital management
Outcome death, therapeutic INR