Guideline-based consultation to prevent anticoagulant-related bleeding. A randomized, controlled trial in a teaching hospital.

OBJECTIVE To test the efficacy of consultation designed to prevent anticoagulant-related bleeding. DESIGN Randomized, controlled trial. SETTING A large teaching hospital. PATIENTS A total of 101 patients at increased (greater than 15%) risk for major, in-hospital bleeding while starting long-term anticoagulant therapy who were identified using a validated prediction rule. INTERVENTIONS Fifty-five patients received usual care under the direction of the attending physician who had initiated anticoagulant therapy. Forty-six patients received guideline-based consultation in addition to usual care. Guideline-based consultation included individualized review of the risks and benefits of anticoagulant therapy and, on the basis of current practice guidelines, recommendations for daily management. MEASUREMENTS The main outcome was in-hospital bleeding, which was classified using a reliable, explicit index. RESULTS Major or minor bleeding occurred in 17 of 55 patients (31%) receiving usual care alone, compared with 6 of 46 patients (13%) receiving consultation in addition to usual care (P = 0.03). The protective efficacy of consultation was 58% (95% CI, 3% to 82%). Consultation was associated with similar reductions in the frequencies of major bleeding (from 13% to 4%) and minor bleeding (from 18% to 9%). Consultative recommendations had an 84% compliance rate and directly affected anticoagulant management: In the consult group, nonsteroidal anti-inflammatory agents were stopped in six patients (13%), and therapeutic ranges were achieved more often for activated partial thromboplastin times (52% compared with 45% in the usual care group, P = 0.08) and for prothrombin times (47% compared with 27% in the usual care group, P less than 0.001). Nearly all housestaff and attending physicians (91%) for patients receiving consultation also reported that consultation improved housestaff learning. The consult group had a somewhat lower rate of thromboembolism in the 90 days after discharge (5% compared with 17%, P = 0.06). Death rates and mean lengths of stay were similar in the two groups. CONCLUSION Guideline-based consultation was associated with reduction in the frequency of anticoagulant-related bleeding in patients at increased risk for major in-hospital bleeding.

[1]  L Goldman,et al.  Major bleeding in outpatients treated with warfarin: incidence and prediction by factors known at the start of outpatient therapy. , 1989, The American journal of medicine.

[2]  M. Mant,et al.  HÆMORRHAGIC COMPLICATIONS OF HEPARIN THERAPY , 1977, The Lancet.

[3]  G. Raskob,et al.  Hemorrhagic complications of long-term anticoagulant therapy. , 1986, Chest.

[4]  M. Peyman.  The significance of haemorrhage during the treatment of patients with the coumarin anticoagulants. , 2009, Acta medica Scandinavica. Supplementum.

[5]  G. Raskob,et al.  Continuous intravenous heparin compared with intermittent subcutaneous heparin in the initial treatment of proximal-vein thrombosis. , 1986, The New England journal of medicine.

[6]  G. Raskob,et al.  Different intensities of oral anticoagulant therapy in the treatment of proximal-vein thrombosis. , 1982, The New England journal of medicine.

[7]  M. Pegg,et al.  Enteral feeds may antagonise warfarin. , 1984, British medical journal.

[8]  J. Hirsh,et al.  A prospective study of the value of monitoring heparin treatment with the activated partial thromboplastin time. , 1972, The New England journal of medicine.

[9]  G. Murray,et al.  THE USE OF HEPARIN IN THROMBOSIS , 1938, Annals of surgery.

[10]  P Smith,et al.  The effect of warfarin on mortality and reinfarction after myocardial infarction. , 1990, The New England journal of medicine.

[11]  G. Mcinnes,et al.  The Performance of Clinics for Out-Patient Control of Anticoagulation , 1987, Journal of the Royal College of Physicians of London.

[12]  J. Carpenter,et al.  Factors affecting compliance for general medicine consultations to non-internists. , 1986, The American journal of medicine.

[13]  E. Sellers,et al.  Drug Interactions with Coumarin Anticoagulants , 1971 .

[14]  P. M. Aggeler,et al.  Determinants of the response to oral anticoagulant drugs in man. , 1970, Pharmacological reviews.

[15]  H. Cohen,et al.  Effect of a geriatric consultation team on functional status of elderly hospitalized patients. A randomized, controlled clinical trial. , 1989, Annals of Internal Medicine.

[16]  Kempin Sj.  Warfarin resistance caused by broccoli. , 1983 .

[17]  J. Martinoff,et al.  Pharmacist-directed heparin therapy using a standard dosing and monitoring protocol. , 1985, American journal of hospital pharmacy.

[18]  V. Mor,et al.  The Senior Care Study , 1990, Journal of the American Geriatrics Society.

[19]  E. Crowell,et al.  Randomized prospective trial of continuous vs intermittent heparin therapy. , 1976, JAMA.

[20]  A. Zweifler.  Relation of Prothrombin Concentration to Bleeding during Oral Anticoagulant Therapy , 1962 .

[21]  D. Hogan,et al.  Effect of a geriatric consultation service on management of patients in an acute care hospital. , 1987, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[22]  J C Forfar,et al.  Prediction of hemorrhage during long-term oral coumarin anticoagulation by excessive prothrombin ratio. , 1982, American heart journal.

[23]  D. Hogan,et al.  A prospective controlled trial of a geriatric consultation team in an acute-care hospital. , 1990, Age and ageing.

[24]  P. W. Willis,et al.  Hemorrhagic complications of anticoagulant therapy. , 1974, Archives of internal medicine.

[25]  H. Büller,et al.  Serial impedance plethysmography for suspected deep venous thrombosis in outpatients. The Amsterdam General Practitioner Study. , 1986, The New England journal of medicine.

[26]  E. Hines,et al.  The use of dicumarol as an anticoagulant; experience in 2,307 cases. , 1947, Annals of internal medicine.

[27]  J. H. Baron,et al.  Anticoagulation Control with Warfarin by Junior Hospital Doctors , 1987, Journal of the Royal Society of Medicine.

[28]  H. Cohen,et al.  A randomized, controlled clinical trial of a geriatric consultation team. Compliance with recommendations. , 1986, JAMA.

[29]  E F Cook,et al.  Identification and preliminary validation of predictors of major bleeding in hospitalized patients starting anticoagulant therapy. , 1987, The American journal of medicine.

[30]  J. Wilson,et al.  Heparin therapy: a randomized prospective study. , 1979, American heart journal.

[31]  B. Furie,et al.  Comparison of the native prothrombin antigen and the prothrombin time for monitoring oral anticoagulant therapy , 1984 .

[32]  M. Charlson,et al.  General medicine consultation. Lessons from a clinical service. , 1983, The American journal of medicine.

[33]  S A McCurdy,et al.  Home prothrombin time monitoring after the initiation of warfarin therapy. A randomized, prospective study. , 1989, Annals of internal medicine.

[34]  B. Furie,et al.  Randomized prospective trial comparing the native prothrombin antigen with the prothrombin time for monitoring oral anticoagulant therapy. , 1990, Blood.

[35]  L. Goldman,et al.  Ten commandments for effective consultations. , 1983, Archives of internal medicine.

[36]  D. Mungall,et al.  Bayesian pharmacokinetic/pharmacodynamic forecasting of prothrombin response to warfarin therapy: preliminary evaluation. , 1985, Therapeutic drug monitoring.

[37]  Denise H. Kinch,et al.  Diagnostic efficacy of impedance plethysmography for clinically suspected deep-vein thrombosis. A randomized trial. , 2020, Annals of internal medicine.

[38]  M. Zelen.  A new design for randomized clinical trials. , 1979, The New England journal of medicine.

[39]  P. Epstein.  Cassandra and the clinician: are clinical prediction rules changing the practice of medicine? , 1990, Annals of internal medicine.

[40]  L Goldman,et al.  Bleeding in outpatients treated with warfarin: relation to the prothrombin time and important remediable lesions. , 1989, The American journal of medicine.

[41]  F. Davis,et al.  Management of anticoagulation in outpatients: experience with an anticoagulation service in a municipal hospital setting. , 1977, Archives of internal medicine.

[42]  A. Wycherley,et al.  SAFETY AND EFFICACY OF WARFARIN STARTED EARLY AFTER SUBMASSIVE VENOUS THROMBOSIS OR PULMONARY EMBOLISM , 1986, The Lancet.

[43]  L. Goldman,et al.  The bleeding severity index: validation and comparison to other methods for classifying bleeding complications of medical therapy. , 1989, Journal of clinical epidemiology.

[44]  S. Gitel,et al.  Warfarin. From bedside to bench. , 1984, The New England journal of medicine.

[45]  C. Landefeld,et al.  A bleeding risk index for estimating the probability of major bleeding in hospitalized patients starting anticoagulant therapy. , 1990, The American journal of medicine.

[46]  J. Hirsh,et al.  Bleeding associated with antithrombotic therapy. , 1980, Seminars in hematology.

[47]  E W Salzman,et al.  Management of heparin therapy: Controlled prospective trial. , 1975, The New England journal of medicine.

[48]  M. Enkin,et al.  Do practice guidelines guide practice? The effect of a consensus statement on the practice of physicians. , 1989, The New England journal of medicine.

[49]  A. Gallus,et al.  Trial of different intensities of anticoagulation in patients with prosthetic heart valves. , 1990, The New England journal of medicine.

[50]  Palle Petersen,et al.  PLACEBO-CONTROLLED, RANDOMISED TRIAL OF WARFARIN AND ASPIRIN FOR PREVENTION OF THROMBOEMBOLIC COMPLICATIONS IN CHRONIC ATRIAL FIBRILLATION The Copenhagen AFASAK Study , 1989, The Lancet.

[51]  J. Forfar.  A 7-year analysis of haemorrhage in patients on long-term anticoagulant treatment. , 1979, British heart journal.