Anderson, Jan

Abstract Use of Direct oral anticoagulants (DOAC) has increased exponentially since their introduction in 2010. Over the years they have been used without any systematic oversight, there have been ongoing concerns related to inappropriate or incorrect dosing, incorrect duration, and non-adherence to the drugs leading to adverse patient outcomes. Several factors have been attributed to DOAC non-adherence such as presence or fear of adverse effects, affordability, lack of perceived benefit, or concerns for reversibility. These barriers impact both primary (first time prescription) and secondary adherence (longer term prescription). Poor adherence can lead to adverse outcomes such as stroke, death, and higher medical resource utilization hence increased cost to the patient and payors. This study was conducted as a quality improvement (QI) initiative to improve the adherence to the prescription DOACS. We included patients 18 years old, a diagnosis of Atrial fibrillation and flutter who had a primary care provider writing the prescription for chronic DOAC therapy. Patients with venous thrombosis, pregnancy or who were institutionalized were excluded. The charts were reviewed for primary and secondary adherence using Surescripts functionality which can provide baseline information about prescription fills from the participating pharmacies. In the preimplementation phase we identified 1030 patients meeting inclusion criteria associated with the pilot sites within Mayo Clinic practice in preceding 6 months. For this population, Surescripts data found that the rates of primary and secondary adherence to be 84% and 86% respectively. We then implemented a 6-month pilot where we created workflow for a pharmacy led DOAC management unit. Herein, once a DOAC prescription was made for patients meeting inclusion criteria, they would enter a registry where the pharmacy team would review the charts for primary adherence by utilizing Surescripts data. If adherent these patients would be marked for follow up in the secondary adherence phase. However, if non adherent, the team would initiate intervention including engagement with patient online services which was further escalated to phone calls by the pharmacy team. Once the barriers were identified several remediation approaches were incorporated in the process, these included education about DOACS, medicare education, social work assistance to even switching to warfarin if necessary. The same process was followed for secondary adherence management. In the intervention cohort, we had 411 patients during the pilot, for primary adherence 87.1% of patients were adherent at baseline and an additional 3.4% became adherent with interventions, while 9.5% remain nonadherent. The primary causes of nonadherence, amongst 9.5%, were cost (86%) while 1% were concerned about side effects and 3% were concerned about lack of perceived benefit. The inverntions lead to impoved adherence in most patients and very few patients were transitioned to warfarin. For secondary adherence 92% of the patients were adherent without any intervention, an additional 4% of patients benefited with the interventions of the DOAC management unit with approaches to address cost considerations, while another 4% remained nonadherent where cost remained the primary reason for nonadherence, other reasons being lack of perceived benefit and side effect concerns. In summary, with active intervention, in our patient population we were able to improve the primary adherence from 84% to 91% and secondary adherence from 86% to 96% . Cost remained the biggest barrier for adherence followed by concern for side effects and lack of perceived benefit. Our engaged team of pharmacy staff was able to manage those concerns with the education and cost mitigation strategies leading to improved adherence. Based on previously published literature even a 5% difference in adherence to DOACS can make a huge difference in population-based outcomes. Our work was able to demonstrate a positive impact of the intervention, highlighting the need for a well-managed DOAC unit especially for complex care populations.

Background The vitamin K antagonist, warfarin, is the preferred anticoagulant in patients with antiphospholipid syndrome (APS). Direct oral anticoagulant (DOAC) use in APS is associated with inferior outcomes, including significantly increased odds of arterial thrombotic events, particularly cerebrovascular accidents (CVA). Despite growing evidence supporting warfarin as the preferred first-line agent, DOACs continue to be utilized by providers in the management of APS. The primary aim of this analysis was to scrutinize the patients with a diagnosis of APS and their anticoagulant choices, to identify quality gaps such as unconfirmed diagnosis (with the need for further testing), lack of awareness of the evidence by the prescribing provider or inadequate documentation of risk benefit conversation, versus patient preference and then systematically intervene to reduce the utilization of DOACS in this patient population. Methods We retrospectively reviewed 100 patients with an ICD code diagnosis of APS documented in the electronic health record (EHR) who were recently prescribed a DOAC within Mayo Clinic enterprise. These cases were assessed for appropriateness of the diagnosis (defined as having at least one clinical manifestation of APS, including venous/arterial thrombosis and/or adverse pregnancy outcome in the setting of persistent antiphospholipid antibody (aPL) positivity by Sapporo criteria). aPL positivity was defined as having positive tests on two occasions with a minimum of 12 weeks apart. Antiphospholipid antibody testing included anticardiolipin (aCL) antibodies (IgG and IgM), anti-beta2 glycoprotein I antibodies (IgG and IgM) and lupus anticoagulant (LA). If the patient met diagnostic criteria, they were then risk stratified to identify high-risk cases. High-risk profile was defined as persistently positive levels of all three aPL (triple-positive). Following review for the appropriate diagnosis, intervention gaps were identified, including the need for additional diagnostic testing, provider education, documenting risk-benefits discussion, and removal of APS from the patient's problem list in the EHR. Clinical intervention was done by sending an EHR message to the prescribing provider which included reason for communication, intervention and recommendation. Reminders were sent every 2 weeks to providers who did not respond, with maximum of 3 messages per provider. Results Of the 100 patients, 60/100 (60%) did not meet criteria for APS, as either initial or repeat aPL testing was negative, and therefore were excluded from this project. Within the remaining 40 patients, 17/100 (17%) had thrombotic APS and 23/100 (23%) had unconfirmed diagnosis Reasons for no intervention (20/40) included not meeting criteria for APS, no longer on a DOAC, and risk versus benefits discussion documented. After adjudication only 20 patients qualified for intervention, 10/20 (50%) patients required additional testing due to lack of repeat testing or referral to a specialist, 7/20 (35%) required removal of APS from problem list, and 3/20 (15%) needed provider. Only 12/20 (65%) of providers accepted the recommendation, 7/20 (35%) did not, and 1/20 (5%) did not respond. Conclusions Despite syndrome-defining criteria, APS remains a commonly misdiagnosed condition. Our QI analysis found that more than half of patients in our cohort with HER documented diagnosis of APS did not meet the Sapporo diagnostic criteria. The tested intervention was time-intensive and prospective, which may have contributed to limited provider acceptance. We propose a robust system-based intervention to remedy this quality issue, which will leverage the EHR to create smart tools in the form of order sets and a passive Our Best Practice Advisory alert to highlight incomplete testing or suggest follow up lab testing at 12 weeks. We will also integrate just in time provider education resources and material embedded in the orders. Our future goal is to assess the impact of this intervention with a similarly sampled cohort.

Background A multidisciplinary approach improves guideline‐directed medical therapy in systolic heart failure (HF), but its efficacy in patients with HF due to cardiac sarcoidosis is unreported. Methods and Results In a retrospective cohort study, we reviewed 848 patients from our institutional cardiac sarcoidosis clinics, identifying those with a cardiac sarcoidosis diagnosis, HF (left ventricular ejection fraction <50%) at index evaluation, and echocardiograms within 90 days and 11 to 36 months. Patients were stratified by participation in a pharmacist‐led medication therapy management (MTM) program for guideline‐directed medical therapy optimization (MTM versus non‐MTM [NMTM]) without randomization. Demographics, left ventricular ejection fraction, guideline‐directed medical therapy (quantified by Kansas City Medical Optimization score), and immunosuppressive therapy were assessed. Primary outcomes included changes in Kansas City Medical Optimization score, left ventricular ejection fraction, and cardiovascular event–free survival (unplanned HF hospitalization, left ventricular assist device /heart transplant, or death). The final cohort included 111 patients (median age, 57 years; 34% women; 64% New York Heart Association class I–II); 43 (39%) were MTM and 68 (61%) were NMTM. Mean Kansas City Medical Optimization score was similar at index evaluation (MTM, 23.2; NMTM, 29.6; P =0.83). At follow‐up (median, 16 months), the Kansas City Medical Optimization score increased significantly in both groups (MTM, 23.2 to 74.8; P <0.001; NMTM, 29.6 to 58.7; P <0.001) but was higher in MTM ( P =0.001). Mean left ventricular ejection fraction trended toward higher values in MTM (44.4% versus 40.0%, P =0.05). The primary clinical outcome occurred in 1 MTM (2.3%) and 16 NMTM (23.5%) patients, with higher risk in NMTM (hazard ratio, 11.97 [95% CI, 1.58–90.54]; P =0.002). Conclusions In this retrospective cohort study, a pharmacist‐led MTM program was associated with favorable guideline‐directed medical therapy optimization and lower risk of adverse cardiovascular outcomes in patients with cardiac sarcoidosis with HF.