A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin. A randomized, controlled trial.
ABSTRACT Warfarin is effective in the treatment and prevention of many venous thromboembolic disorders, but it often leads to bleeding.
To develop a multicomponent program of management of warfarin therapy and to determine its effect on the frequency of warfarin-related major bleeding in older patients.
Randomized, controlled trial.
University hospital in Cleveland, Ohio.
325 patients 65 years of age or older who started warfarin therapy during hospitalization.
Patients were stratified according to baseline risk for major bleeding and were randomly assigned to receive the intervention (n = 163) or usual care (n = 162) by their primary physicians for 6 months. The intervention consisted of patient education about warfarin, training to increase patient participation, self-monitoring of prothrombin time, and guideline-based management of warfarin dosing.
Major bleeding, death, recurrent venous thromboembolism, and therapeutic control of anticoagulant therapy at 6 months.
In an intention-to-treat analysis, major bleeding was more common at 6 months in the usual care group than in the intervention group (cumulative incidence, 12% vs. 5.6%; P = 0.0498, log-rank test). The most frequent site of major bleeding in both groups was the gastrointestinal tract. Death and recurrent venous thromboembolism occurred with similar frequency in both groups at 6 months. Throughout 6 months, the proportion of total treatment time during which the international normalized ratio was within the therapeutic range was higher in the intervention group than in the usual care group (56% vs. 32%; P < 0.001). After 6 months, major bleeding occurred with similar frequencies in the intervention and usual care groups.
A multicomponent comprehensive program of warfarin management reduced the frequency of major bleeding in older patients. Although the generalizability and cost-effectiveness of this program remain to be demonstrated, these findings support the premise that efforts to reduce the likelihood of major bleeding will lead to safe and effective use of warfarin therapy in older patients.
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ABSTRACT: Of 125 patients aged 65 years or over, with atrial fibrillation taking warfarin for at least 12 months, with a standard deviation (SD) of prothrombin time, expressed as the International Normalized Ratio (INR) >0.5 over the previous 6 months, 40 were randomized to continue with usual clinic care and 85 to receive education about warfarin. Of these, 44 were randomized to self-monitor their INR and 41 returned to clinic. Compared with the previous 6 months there was a significant increase in percentage time within the therapeutic range for the 6 months following education [61.1 vs. 70.4; mean difference 8.8; 95% confidence interval (CI): -0.2-17.8; P = 0.054] and following education and self-monitoring (57 vs. 71.1; mean difference 14.1; 95% CI: 6.7-21.5; P < 0.001), compared with those patients following usual clinic care (60.0 vs. 63.2; mean difference 3.2; 95% CI: -7.3-13.7). Using the same comparative periods, the INR SD fell by 0.24 (P < 0.0001) in the group allocated to education and self-monitoring, 0.26 (P < 0.0001) in the group receiving education alone and 0.16 (P = 0.003) in the control group. Inter-group differences were not statistically significant (intervention groups 0.26 +/- 0.30 vs. control 0.16 +/- 0.3, P = 0.10). Quality-of-life measurements and health beliefs about warfarin were unchanged (apart from emotional role limitation) with education or education and self-monitoring. Patient education regarding anticoagulation therapy could be a cost-effective initiative and is worthy of further study.British Journal of Haematology 09/2004; 126(4):557-64. DOI:10.1111/j.1365-2141.2004.05074.x · 4.96 Impact Factor
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ABSTRACT: Home monitoring devices encourage people to actively participate in their health care management. In addition, access to more data may help to make better decisions, which may ultimately lead to better health outcomes. The primary focus of this article will be on blood glucose, blood pressure, prothrombin time, and peak flow meters. The empirical evidence on the accuracy and usefulness of these home monitoring devices is discussed. Based on the evidence from the literature, erroneous reporting of the readings by the patients is a major concern. Therefore, primary practitioners are encouraged to consult with patients’ log books and their meters (if memory feature is available), instead of relying solely on self-reported values. Patients also need to be educated and trained adequately about the proper measurement technique and relevance and interpretation of the readings. Continuing education is necessary regarding the behavioral and therapeutic changes patients should carry out in accordance with performing regular home monitoring.Journal of Pharmacy Practice 06/2004; 17(3):182-196. DOI:10.1177/0897190004264815
- American heart journal 04/2007; 153(4 Suppl):74-80. DOI:10.1016/j.ahj.2007.01.017 · 4.56 Impact Factor