Post-conference session: Experience with patient self-management of oral anticoagulation

Long-term oral anticoagulation requires careful patient monitoring in order to optimize results and to limit hemorrhagic or thromboembolic complications of treatment. For this reason, any improvement in anticoagulant control and management can be expected to have far-reaching consequences in extending longevity and decreasing complications in anticoagulated patients after heart valve surgery. Because one attractive means of improving anticoagulant management is to give patients a share of the responsibility, a program was designed to encourage patients to take an active role in monitoring their own prothrombin time (PT) and managing their own oral anticoagulation. During the period from August 1986 to February 1992, 600 patients requiring long-term anticoagulation, mainly after heart valve replacement, were trained to measure their own PT at the Cardiac Rehabilitation Center (Herz-Krauslauf-Klinik, Bad Berleburg, Germany) and to manage their own therapy: 216 patients could be followed with regard to their self-determined prothrombin times. The results were within the target range in 83.1% of the PT determinations (n=12,306 measurements) taken by the patients themselves. Neither major bleeding nor thromboembolic complications were observed in 205 patient-years of self-monitoring of PT and self-management of oral anticoagulation.     

Patient-centred and professional-directed implementation strategies for diabetes guidelines: a cluster-randomized trial-based cost-effectiveness analysis.

AIMS: Economic evaluations of diabetes interventions do not usually include analyses on effects and cost of implementation strategies. This leads to optimistic cost-effectiveness estimates. This study reports empirical findings on the cost-effectiveness of two implementation strategies compared with usual hospital outpatient care. It includes both patient-related and intervention-related cost. PATIENTS AND METHODS: In a clustered-randomized controlled trial design, 13 Dutch general hospitals were randomly assigned to a control group, a professional-directed or a patient-centred implementation programme. Professionals received feedback on baseline data, education and reminders. Patients in the patient-centred group received education and diabetes passports. A validated probabilistic Dutch diabetes model and the UKPDS risk engine are used to compute lifetime disease outcomes and cost in the three groups, including uncertainties. RESULTS: Glycated haemoglobin (HbA(1c)) at 1 year (the measure used to predict diabetes outcome changes over a lifetime) decreased by 0.2% in the professional-change group and by 0.3% in the patient-centred group, while it increased by 0.2% in the control group. Costs of primary implementation were < 5 Euro per head in both groups, but average lifetime costs of improved care and longer life expectancy rose by 9389 Euro and 9620 Euro, respectively. Life expectancy improved by 0.34 and 0.63 years, and quality-adjusted life years (QALY) by 0.29 and 0.59. Accordingly, the incremental cost per QALY was 32 218 Euro for professional-change care and 16 353 for patient-centred care compared with control, and 881 Euro for patient-centred vs. professional-change care. Uncertainties are presented in acceptability curves: above 65 Euro per annum the patient-directed strategy is most likely the optimum choice. CONCLUSION: Both guideline implementation strategies in secondary care are cost-effective compared with current care, by Dutch standards, for these patients. Additional annual costs per patient using patient passports are low. This analysis supports patient involvement in diabetes in the Netherlands, and probably also in other Western European settings.     

Patient education and self-management of musculoskeletal diseases

The research literature reports that patient (consumer) education and self-management programs and practices help people with chronic disease live better lives by improving health outcomes and psycho-emotional and psychosocial measures. However, arthritis charities that offer self-management programs in the United Kingdom, the United States and Canada anecdotally report significant drops in enrollment, and emerging data suggest that these types of programs are not a panacea for people attending them. This chapter will provide the reader with the following: an introduction to patient education and self-management; a discussion on participation rates in patient education and arthritis self-management programs; an overview of the 'state-of-the-art' in patient education and self-management programs; new ideas on patient education delivery models; tips on improving physician-patient communication; and suggested areas of research required to advance the area of patient education and self-management.     

Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II.

AIMS: In mechanical heart valve recipients, low-dose international normalized ratio (INR) self-management of oral anticoagulants can reduce the risk of developing thrombo-embolic events and improve long-term survival compared with INR control by a general practitioner. Here, we present data on the safety of low-dose INR self-management. METHODS AND RESULTS: In a prospective, randomized multi-centre trial, 1346 patients with a target INR range of 2.5-4.5 and 1327 patients with a target INR range of 1.8-2.8 for aortic valve recipients and an INR range of 2.5-3.5 for mitral or double valve recipients were followed up for 24 months. The incidence of thrombo-embolic events that required hospital admission was 0.37 and 0.19% per patient year in the conventional and low-dose groups, respectively (P = 0.79). No thrombo-embolic events occurred in the subgroups of patients with mitral or double valve replacement. The incidence of bleeding events that required hospital admission was 1.52 and 1.42%, respectively (P = 0.69). In the majority of patients with bleeding events, INR values were < 3.0. Mortality rate did not differ between the study groups. CONCLUSION: Data demonstrate that low-dose INR self-management does not increase the risk of thrombo-embolic events compared with conventional dose INR self-management. Even in patients with low INR target range, the risk of bleeding events is still higher than the risk of thrombo-embolism.     

Advances in the monitoring of oral anticoagulation: Point-of-care testing, patient self-monitoring, and patient self-management

Oral anticoagulation with warfarin sodium has proven to be an effective therapy for patients at risk for thromboembolic disease, but due to its high risk/benefit ratio, many physicians are reluctant to prescribe the drug. The development of capillary whole-blood prothrombin time (PT) monitors provides a potential means to decrease this risk/benefit ratio and to encourage the use of warfarin. Studies show that this technology is accurate, precise, and correlates closely with standard laboratory methods. Given that these monitors are simple and portable, investigators have conducted studies to determine their suitability for patient self-testing and home monitoring. Investigations show that patients can accurately and precisely perform the PT test at home, and that this mode of therapy appears to be at least as safe and effective as standard management. Furthermore, limited studies also suggest that patients can also manage their own dosing based on personalized guidelines designed by a physician. Given the theoretical potential for improved patient outcomes and overall cost reduction, patient self-monitoring and self-management are not far off. Large randomized prospective trials are now needed to confirm that the future of anticoagulation management should include patient self-monitoring and patient self-management of therapy.     

Patient and physician satisfaction with a telephone-based anticoagulation service

OBJECTIVES: To compare the satisfaction and knowledge of patients who have their warfarin managed by their physician or by a multidisciplinary, telephone-based anticoagulation service (ACS) and to assess referring physicians' satisfaction with the ACS. DESIGN AND PARTICIPANTS: We surveyed 300 patients taking warfarin (mean age 73 years): 150 at health centers randomized to have access to an ACS, and 150 at control health centers without ACS access. We also surveyed 17 physicians who refer patients to the ACS. SETTING: Eight outpatient health centers in Missouri and Southern Illinois. MEASUREMENTS: We asked patients about the timeliness of international normalized ratio (INR) monitoring, perceived safety of warfarin, overall satisfaction with their warfarin management, and knowledge of what a high INR meant. We asked physicians at ACS-available health centers how many minutes they saved per INR by referring patients to the ACS, their satisfaction with the ACS, and their willingness to recommend the ACS to a colleague. MAIN RESULTS: As compared with patients at control health centers, patients at ACS-available health centers were more satisfied with the timeliness of getting blood test results (mean 4.31 vs 4.03, P =.02), were more likely to know what a safe INR value was (45% vs 15%, P =.001), and felt safer taking warfarin (mean 5.7 vs 5.2, P =.04). Physicians reported that using the ACS saved, on average, four minutes of their time and 13 minutes of their staff's time, per INR. All physicians recommended use of the ACS to a colleague and were highly satisfied with the ACS. CONCLUSIONS: A telephone-based ACS can be endorsed by primary-care physicians and improve patients' satisfaction with and knowledge about their antithrombotic therapy.     

Patient self-management of oral anticoagulation: a review

Self-management of warfarin is an evolving strategy that involves self-testing of the international normalized ratio using a point-of-care device and adjustment of warfarin dosage by the patient using a dosage-adjustment nomogram. There is mounting evidence from clinical trials that self-management of warfarin is feasible and is potentially superior to conventional management by physicians in maintaining anticoagulation control. Some advantages of this strategy are convenience, rapid availability of results with timely adjustment of warfarin dosages, increased patient responsibility for their own therapy and enhanced patient satisfaction. Access to point-of-care instruments may prove particularly valuable for patients without ready access to laboratories, frequent travellers who are often away from their home laboratory for extended periods of time and those who experience difficulties with venous blood collection. Self-management may be considered for carefully selected and properly trained individuals. Information from several ongoing clinical trials will aid in determining the value of anticoagulation self-management with respect to complication rates and economic outcomes.     

Patient self‐management of oral anticoagulation

Patient self‐management of oral anticoagulation is now widely practised in Germany and the USA. There are three different home‐testing monitors available in the UK which are all reliable in terms of accuracy and reproducibility of results. Selected patients can be trained to perform their own International Normalized Ratio (INR) testing and dosing, with outcomes as good if not better than those from specialized anticoagulant clinics. Consensus on the frequency of testing and what quality control should be deployed is lacking. The cost‐effectiveness in the UK is unproven.     

Patient self-management of oral anticoagulation

More than six million patients worldwide are being treated with an oral anticoagulant. Dosing of the anticoagulant is usually managed by a primary care physician, cardiologist, or a specialized anticoagulation clinic. With the introduction of point-of-care testing devices, it is possible for patients to monitor their coagulation time, the international normalized ratio, at home. Selected patients, when properly trained, are capable of managing their oral anticoagulation treatment from home, so-called patient self-management (PSM). PSM has been practiced for many years in Europe, where training centers and reimbursement are well established. Because the US Center for Medicare and Medicaid Services recently decided to cover PSM, the practice will likely become more common in the United States. This article reviews the evidence behind the efficacy, safety, and cost effectiveness of PSM.     

The cost-effectiveness of different management strategies for patients on chronic warfarin therapy

OBJECTIVE: To examine the cost-effectiveness of moving from usual care to more organized management strategies for patients on chronic warfarin therapy. DESIGN: Using information available in the scientific literature, supplemented with data from a large health system and, when necessary, expert opinion, we constructed a 5-year Markov model to evaluate the health and economic outcomes associated with each of three different anticoagulation management approaches: usual care, anticoagulation clinic testing with a capillary monitor, and patient self-testing with a capillary monitor. PATIENTS: Three hypothetical cohorts of patients beginning long-term warfarin therapy were used to generate model results. MAIN RESULTS: Model results indicated that moving from usual care to anticoagulation clinic testing would result in a total of 1.7 thromboembolic events and 2.0 hemorrhagic events avoided per 100 patients over 5 years. Another 4.0 thromboembolic events and 0.8 hemorrhagic events would be avoided by moving to patient self-testing. When direct medical care costs and those incurred by patients and their caregivers in receiving care were considered, patient self-testing was the most cost-effective alternative, resulting in an overall cost saving. CONCLUSIONS: Results illustrate the potential health and economic benefits of organized care management approaches and capillary monitors in the management of patients receiving warfarin therapy.     

Patient self-management of oral anticoagulation

Patient self-management of oral anticoagulation is now widely practised in Germany and the USA. There are three different home-testing monitors available in the UK which are all reliable in terms of accuracy and reproducibility of results. Selected patients can be trained to perform their own International Normalized Ratio (INR) testing and dosing, with outcomes as good if not better than those from specialized anticoagulant clinics. Consensus on the frequency of testing and what quality control should be deployed is lacking. The cost-effectiveness in the UK is unproven.     

The effectiveness of cost-effectiveness analysis in containing costs

OBEJCTIVE: Although cost-effectiveness analyses (CEAs) have been advocated as a tool to critically appraise the value of health expenditures, it has been widely hoped that they might also help contain health care costs. To determine how often they discourage additional expenditures, we reviewed the conclusions of recently published CEAs. DATA SOURCES: A search of the Abridged Index Medicus (a subset of MEDLINE designed to afford rapid access to the literature of “immediate interest” to the practicing physician) between 1990 and 1996. STUDY SELECTION: We only included articles that reported an explicit cost-effectiveness (CE) ratio (a cost for some given health effect) in the abstract. DATA ABSTRACTION: From each abstract, we collected the value for the incremental CE ratio and the measure of health effect (life-years, quality-adjusted life-years [QALYs], other). We then categorized the authors’ conclusion into one of three categories: supports strategy requiring additional expenditure, no firm conclusion, and supports low-cost alternative. Finally, we obtained the article and collected information on funding source. DATA SYNTHESIS: Among the 109 eligible articles, the authors’ conclusion supported strategies requiring additional expenditure in 58 (53%) and supported the low-cost alternative in 28 (26%). We then focused on the 65 articles reporting either life-years or QALYs. Cost-effectiveness ratios ranged from $400 to $166,000 (per life-year or QALY) in the 39 articles (60%) in which authors supported additional expenditure, and ranged from $61,500 to $11,600,000 in the 13 articles (20%) in which authors supported the low-cost alternative. Despite identifying similar CE ratios, authors arrived at different conclusions in the overlapping range ($61,500 to $166,000). Of the 10 articles acknowledging industry funding, 9 supported a strategy requiring additional expenditure (p=.01 as compared with those without such funding). CONCLUSIONS: Authors of CEAs are more likely to support strategies requiring additional expenditure than the low-cost alternative. There is no obvious consensus about how small the CE ratio should be to warrant additional expenditure. Finally, concerns about funding source seem to be warranted.     

Patient self-management of long-term oral anticoagulation in Switzerland

Indications for oral anticoagulation (OAC) have increased in recent years. OAC requires frequent monitoring of the prothrombin time to keep the intensity within the therapeutic range and to minimise the risk for complications. Patient self-management (PSM) has been found to improve the quality of OAC. The present study aimed to investigate the first 330 patients performing PSM in Switzerland. A questionnaire was sent to all patients who followed a teaching program for PSM of OAC between 1998 and 2003. Moreover, family physicians were contacted and/or discharge letters were obtained from the hospitals or the treating physicians. During the study period 13 patients died. Out of the 300 patients providing information 254 (85%) still perform PSM. At least one INR determination per two weeks was done by 74% of the patients and 25% performed at least one INR measurement every 15-30 days. The median time spent within the individual INR target range was 72%. No thromboembolic complications occurred, however, among the 13 patients who died, 1 had myocardial infarction and 6 died of heart failure. When counting these events as arterial thromboembolic complications the frequency was 0.6 (95% CI: 0.3-1.3) per 100 patient-years. The frequency of major bleeding was 0.6 (95% CI: 0.2-1.3) per 100 patient-years. We conclude from this study investigating a real-world patient collective that PSM is suitable and safe for the patients identified by their family physicians and successfully trained by our training centre.     

Chemoprevention of colorectal cancer by aspirin: a cost-effectiveness analysis.

BACKGROUND & AIMS: The aim of the study is to compare the cost-effectiveness of aspirin and colonoscopy in the prevention of colorectal cancer. METHODS: A Markov process is used to follow a hypothetical cohort of 100,000 subjects aged 50 years until death. Four strategies are compared: (1) no intervention, (2) colonoscopy once per 10 years and every 3 years in subjects with polyps, (3) chemoprevention with 325 mg of daily aspirin, and (4) combination of the second and third strategies. The various strategies are compared calculating incremental cost-effectiveness ratios (ICERs). RESULTS: The expected number of colorectal cancers is 5904 per 100,000 subjects. Colonoscopy prevents 4428 colorectal cancers and saves 7951 life-years at an ICER of $10,983 per life-year saved compared with no intervention. Aspirin prevents 2952 colorectal cancers and saves 5301 life-years at an ICER of $47,249 per life-year saved compared with no intervention. The cost of aspirin therapy plus management of aspirin-related complications was reported to be $172 per year per patient. Varying the annual aspirin-related costs between $50 and $200 results in ICER changes between $4617 and $57,080, with the 2 strategies breaking even at $70. Applying aspirin chemoprevention plus colonoscopy screening concomitantly yields an ICER of $227,607 per life-year saved compared with screening colonoscopy alone. CONCLUSION: As compared with colonoscopy once per 10 years, the use of aspirin to prevent colorectal cancer saves fewer lives at higher costs. The high complication cost and the lower efficacy of aspirin render screening colonoscopy a more cost-effective strategy to prevent colorectal cancer.     

Drug policy for visceral leishmaniasis: a cost-effectiveness analysis

OBJECTIVE: To facilitate the choice of the best visceral leishmaniasis (VL) treatment strategy for first-line health services in (VL)-endemic areas, we compared in a formal decision analysis the cost and the cost-effectiveness of the different available options. METHODS: We selected four drug regimens for VL on the basis of frequency of use, feasibility and reported efficacy studies. The point estimates and the range of plausible values of effectiveness and cost were retrieved from a literature review. A decision tree was constructed and the strategy minimizing the cost per death averted was selected. RESULTS: Treatment with amphotericin B deoxycholate was the most effective approach in the baseline analysis and averted 87.2% of all deaths attributable to VL. The least expensive and the most cost-effective treatment was the miltefosine regimen, and the most expensive and the least cost-effective was AmBisome treatment. The cost of drug and medical care are the main determinants of the cost-effectiveness ranking of the alternative schemes. Sensitivity analysis showed that antimonial was competitive with miltefosine in the low-resistance regions. CONCLUSION: In areas with >94% response rates to antimonials, generic sodium stibogluconate remains the most cost-effective option for VL treatment, mainly due to low drug cost. In other regions, miltefosine is the most cost-effective option of treatment, but its use as a first-line drug is limited by its teratogenicity and rapid resistance development. AmBisome in mono- or combination therapy is too expensive to compete in cost-effectiveness with the other regimens.     

Bridging anticoagulation therapy

Oral anticoagulation therapy is used in patients with various diagnoses to reduce the risk of thromboembolic events or to induce a hypocoagulation state to facilitate dissolution of a thrombus. In clinical practice we often encounter anticoagulated patients, many of whom have been diagnosed with nonvalvular atrial fibrillation. Each year a significant number of these patients undergo a medical procedure, which, in some cases, requires temporary discontinuation of anticoagulation therapy. However without anticoagulation therapy, the patient is at increased risk of thromboembolic events. Therefore, parenteral anticoagulants with fast onset and rapid cessation of action can be used to reduce risk while patients are without adequate oral anticoagulation. Here we summarized the currently available data, which has been drawn from guidelines and other expert documents of European Society of Cardiology (ESC), American College of Cardiology (ACC) and American College of Chest Physicians (CHEST). The vast majority of available studies, including the only single randomized, double-blind, placebo-controlled BRIDGE trial, report an increased risk of major bleeding in patients on bridging therapy. A subanalysis of the RE-LY trial, also found that thromboembolic risk in patients with bridging therapy was significantly higher. The most detailed recommendation for use of bridging therapy in patients with nonvalvular atrial fibrillation was provided by the 2017 Expert Consensus of the ACC, while the ESC only marginally discusses bridging therapy in their expert documents. Bridging is not generally necessary in patients taking non-vitamin K oral anticoagulants (NOACs), but if clinical circumstances require it, the risks and benefits are the same as with vitamin K antagonist (VKA) anticoagulation. Data on the use of NOACs for bridging therapy are scarce.     

A randomised control trial of patient self-management of oral anticoagulation compared with patient self-testing

Several studies suggest that patient self-management (PSM) may improve the quality of oral anticoagulation therapy as measured by time spent within the international normalised ratio (INR) target range. We performed a prospective randomised control trial to determine whether the improvement in quality of treatment afforded by PSM is greater than that achieved by patient self-testing (PST) alone. A total of 104 of 800 eligible patients aged 22-88 years (median = 59.8), attending our hospital anticoagulant clinic and receiving long-term warfarin for >8 months agreed to participate. Patients were randomised to PSM (n = 55) or PST (n = 49). Both groups measured their INR using the CoaguChek S every 2 weeks or more frequently if required, for a period of 6 months. Seventy-seven of 104 (74%) patients completed the study (PSM = 41 and PST = 36). The 'drop out' rates for both groups were similar. There was no significant difference between the percentage time in target therapeutic range for PSM (69.9%) and PST (71.8%). Both groups combined showed a significant improvement over the previous 6 months (71.0% vs. 62.5%; P = 0.04). Changes in time within the therapeutic range in individual patients (+5.86) also showed a significant difference. The quality of warfarin control in both PST and PSM may be superior to that achieved by conventional management in a specialised hospital anticoagulation clinic.     

BRIEF REPORT: The burden of diabetes therapy

BACKGROUND: Management of diabetes, and in particular blood glucose, can be complex and burdensome. OBJECTIVE: To evaluate patient views of the burdens of therapy and its impact on self-management. PATIENTS: Veteran patients with type 2 diabetes. DESIGN: Mailed survey. MEASUREMENTS: Patients described their views of the burden of diabetes treatments, adherence, and clinical and demographic status. Factors associated with ratings of burden and adherence to therapy were examined using multivariate regression methods. RESULTS: The response rate was 67% (n=1,653). Patients viewed pills as the least burdensome treatment and insulin as the most burdensome. Ratings of the burden of insulin were lower if a patient had prior experience with therapy. Adherence to prescribed therapy varied substantially; for example, patients followed medication recommendations more closely than other areas of self-management. Multivariate analyses showed that the main predictor of adherence was patients' ratings of the burden of therapy. CONCLUSIONS: Injected insulin regimens are viewed as highly burdensome by patients, although this burden is attenuated by experience. Adherence to self-management is strongly and independently correlated with views of treatment burden. The burden of diabetes-related treatments may be a source of suboptimal glucose control seen in many care settings. Providers should consider the burden of treatment for a particular patient and its impact on adherence as part of a decision-making process to design effective treatment regimens.