Identification of risk factors for inappropriate and suboptimal initiation of direct oral anticoagulants.

Direct Oral Anticoagulants (DOACs) require specific dosing and monitoring to ensure safe and appropriate use. The purpose of this evaluation was to identify patient- and process-related factors that correlate with increased risk of inappropriate prescribing of DOACs. A retrospective chart review was conducted in three outpatient clinics within an academic medical center to identify patients started on DOAC therapy and evaluate the appropriateness of DOAC initiation. Data collected included patient demographics, DOAC medication initiated, dose, indication, baseline laboratory values, concomitant medications, type and specialty of prescriber, and initiation setting. Appropriateness of initial dose was assessed and data were analyzed in order to identify factors correlating with inappropriate use. One-hundred sixty-seven patients initiated on a DOAC were identified. Most patients were prescribed anticoagulation for atrial fibrillation (74.9 %) and most commonly prescribed rivaroxaban (62.9 %). An inappropriate dose was prescribed in 24 (14.4 %) patients. Female patients and patients over 75 years were more likely to be prescribed an inappropriate initial dose. Baseline evaluation of blood counts and organ function were often not performed: hemoglobin values had not been drawn within the month prior to initiation in 28.7 % of patients, serum creatinine in 22.8 %, alanine transaminase in 52.1 %, and total bilirubin in 64.1 %. Lack of baseline labs was more pronounced in patients initiated on a DOAC in the outpatient setting. Dosing and baseline lab collection for DOAC initiation were suboptimal in all settings analyzed. Targeted interventions are needed to ensure the safe and appropriate use of DOAC therapy.

The association of health literacy with time in therapeutic range for patients on warfarin therapy.

Patients on warfarin therapy need to achieve and maintain anticoagulation control in order to experience the benefits of treatment while minimizing bleeding risk. Low health literacy skills may hinder patients' ability to use and adhere to warfarin in a safe and effective manner. The authors conducted this study to evaluate the relationship between health literacy and anticoagulation control among patients on chronic warfarin therapy. Participants were recruited from 2 diverse anticoagulation clinics in North Carolina. Time in therapeutic range (TTR) for warfarin therapy was used as a measure of anticoagulation control. Health literacy was assessed using the short form of the Test of Functional Health Literacy in Adults (S-TOFHLA). Of the 198 study participants, 51% had limited health literacy (S-TOFHLA score of 0-90) and 33% had poor anticoagulation control (TTR<50%). Participants with limited health literacy were less likely to correctly answer warfarin-related knowledge questions. Limited health literacy was significantly associated with TTR<50% (adjusted odds ratio=2.34, 95% CI [1.01, 5.46]). Findings indicate that limited health literacy is associated with poor anticoagulation control for patients on warfarin therapy. Lack of medication understanding may hinder the safe and effective use of this narrow therapeutic index drug.

A randomized controlled trial of a literacy-sensitive self-management intervention for chronic obstructive pulmonary disease patients.

BACKGROUND: Low literacy skills are common and associated with a variety of poor health outcomes. This may be particularly important in patients with chronic illnesses such as chronic obstructive pulmonary disease (COPD) that require appropriate inhaler technique to maintain quality of life and avoid exacerbations. OBJECTIVE: To explore the impact of a literacy-sensitive self-management intervention on inhaler technique scores in COPD patients and to determine if effects differ by literacy. DESIGN: Randomized controlled trial. PARTICIPANTS: Ninety-nine patients with COPD. INTERVENTION: Patients were randomly assigned to a one-on-one self-management educational intervention or usual care. The intervention focused on inhaler technique, smoking cessation, and using a COPD action plan. MAIN MEASURES: At baseline, an inhaler technique assessment, literacy assessment, health-related quality of life questionnaires, and pulmonary function tests were completed. Inhaler technique was re-evaluated after two to eight weeks. KEY RESULTS: Mean age 63, 65% female, 69% Caucasian, moderate COPD severity on average, 36% with low literacy, moderately impaired health-related quality of life, and similar baseline metered dose inhaler technique scores. Patients in the intervention group had greater mean improvement from baseline in metered dose inhaler technique score compared to those in the usual care group (difference in mean change 2.1, 95% CI 1.1, 3.0). The patients in the intervention group also had greater mean improvements in metered dose inhaler technique score than those in the usual care group whether they had low health literacy (difference in mean change 2.8, 95% CI 0.6, 4.9) or higher health literacy (1.8, 95% CI 0.7, 2.9). CONCLUSIONS: A literacy-sensitive self-management intervention can lead to improvements in inhaler technique, with benefits for patients with both low and higher health literacy.

Use of patient flow analysis to improve patient visit efficiency by decreasing wait time in a primary care-based disease management programs for anticoagulation and chronic pain: a quality improvement study.

BACKGROUND: Patients with chronic conditions require frequent care visits. Problems can arise during several parts of the patient visit that decrease efficiency, making it difficult to effectively care for high volumes of patients. The purpose of the study is to test a method to improve patient visit efficiency. METHODS: We used Patient Flow Analysis to identify inefficiencies in the patient visit, suggest areas for improvement, and test the effectiveness of clinic interventions. RESULTS: At baseline, the mean visit time for 93 anticoagulation clinic patient visits was 84 minutes (+/- 50 minutes) and the mean visit time for 25 chronic pain clinic patient visits was 65 minutes (+/- 21 minutes). Based on these data, we identified specific areas of inefficiency and developed interventions to decrease the mean time of the patient visit. After interventions, follow-up data found the mean visit time was reduced to 59 minutes (+/-25 minutes) for the anticoagulation clinic, a time decrease of 25 minutes (t-test 39%; p < 0.001). Mean visit time for the chronic pain clinic was reduced to 43 minutes (+/- 14 minutes) a time decrease of 22 minutes (t-test 34 %; p < 0.001). CONCLUSION: Patient Flow Analysis is an effective technique to identify inefficiencies in the patient visit and efficiently collect patient flow data. Once inefficiencies are identified they can be improved through brief interventions.

Facilitating behavior change with low-literacy patient education materials.

OBJECTIVE: To describe a process for developing low-literacy health education materials that increase knowledge and activate patients toward healthier behaviors. METHODS: We developed a theoretically informed process for developing educational materials. This process included convening a multidisciplinary creative team, soliciting stakeholder input, identifying key concepts to be communicated, mapping concepts to a behavioral theory, creating a supporting behavioral intervention, designing and refining materials, and assessing efficacy. RESULTS: We describe the use of this process to develop a diabetes self-management guide. CONCLUSIONS: Developing low-literacy health education materials that will activate patients toward healthier behaviors requires attention to factors beyond reading level.

Patient Satisfaction with Medicare Annual Wellness Visits Administered by a Clinical Pharmacist Practitioner.

BACKGROUND: In accordance with the Patient Protection and Affordable Care Act, Medicare provides coverage for annual wellness visits (AWVs) to eligible beneficiaries, which focus on preventative services, furnish personalized preventative health plans, and direct appropriate referrals. These visits may be conducted by a physician or another licensed practitioner working under the direct supervision of a physician. In North Carolina, pharmacists licensed as clinical pharmacist practitioners (CPPs) may perform and bill for AWVs, but there are limited data on patient satisfaction with pharmacists serving in this advanced role. OBJECTIVES: To (a) investigate patient satisfaction with and perception of an initial Medicare AWV administered by a CPP in an academic internal medicine clinic and (b) examine the relationship between patient satisfaction and the number of interventions or referrals made during an AWV. METHODS: All established patients of an academic internal medicine clinic aged 66 years and older were eligible for AWVs with a CPP, and those completing an AWV with a CPP were eligible for inclusion in this study. Patient satisfaction with the CPP and AWV was assessed by a telephone satisfaction questionnaire administered after the visit by a pharmacy student not affiliated with the clinic. RESULTS: Forty-six patients were included in this study. Patients rated their satisfaction with the CPP at a mean of 4.7 and with the visit at a mean of 4.6 on a Likert scale ranging from 1 to 5, where 1 was "very dissatisfied" and 5 was "very satisfied." Using a Likert scale of 1 to 5, where 1 was "strongly disagree" and 5 was "strongly agree," patients responded with a mean of 4.4 that they were comfortable discussing their health information with a CPP and a mean of 4.1 that they were just as comfortable discussing their health information for this visit with a CPP as with their primary care physician. CONCLUSIONS: Overall, patients were very satisfied with the CPP and AWVs and felt comfortable with CPPs as the providers of this service. As such, this study demonstrates that through Medicare AWVs, pharmacists can provide direct patient care and contribute to team-based initiatives. DISCLOSURES: No outside funding supported this study, and the authors have no conflicts of interest to declare. Study concept and design were contributed by Cavanaugh and Shilliday, along with Sherrill. The data were collected by Sherrill and Shilliday and interpreted by Sherrill, Cavanaugh, and Shilliday. The manuscript was written and revised by Sherrill, Cavanaugh, and Shilliday. This work was presented at the ASHP Annual Meeting in Las Vegas, Nevada, on December 3, 2012.

Predictors of opioid misuse in patients with chronic pain: a prospective cohort study.

BACKGROUND: Opioid misuse can complicate chronic pain management, and the non-medical use of opioids is a growing public health problem. The incidence and risk factors for opioid misuse in patients with chronic pain, however, have not been well characterized. We conducted a prospective cohort study to determine the one-year incidence and predictors of opioid misuse among patients enrolled in a chronic pain disease management program within an academic internal medicine practice. METHODS: One-hundred and ninety-six opioid-treated patients with chronic, non-cancer pain of at least three months duration were monitored for opioid misuse at pre-defined intervals. Opioid misuse was defined as: 1. Negative urine toxicological screen (UTS) for prescribed opioids; 2. UTS positive for opioids or controlled substances not prescribed by our practice; 3. Evidence of procurement of opioids from multiple providers; 4. Diversion of opioids; 5. Prescription forgery; or 6. Stimulants (cocaine or amphetamines) on UTS. RESULTS: The mean patient age was 52 years, 55% were male, and 75% were white. Sixty-two of 196 (32%) patients committed opioid misuse. Detection of cocaine or amphetamines on UTS was the most common form of misuse (40.3% of misusers). In bivariate analysis, misusers were more likely than non-misusers to be younger (48 years vs 54 years, p < 0.001), male (59.6% vs. 38%; p = 0.023), have past alcohol abuse (44% vs 23%; p = 0.004), past cocaine abuse (68% vs 21%; p < 0.001), or have a previous drug or DUI conviction (40% vs 11%; p < 0.001%). In multivariate analyses, age, past cocaine abuse (OR, 4.3), drug or DUI conviction (OR, 2.6), and a past alcohol abuse (OR, 2.6) persisted as predictors of misuse. Race, income, education, depression score, disability score, pain score, and literacy were not associated with misuse. No relationship between pain scores and misuse emerged. CONCLUSION: Opioid misuse occurred frequently in chronic pain patients in a pain management program within an academic primary care practice. Patients with a history of alcohol or cocaine abuse and alcohol or drug related convictions should be carefully evaluated and followed for signs of misuse if opioids are prescribed. Structured monitoring for opioid misuse can potentially ensure the appropriate use of opioids in chronic pain management and mitigate adverse public health effects of diversion.

Medicare annual wellness visits conducted by a pharmacist in an internal medicine clinic.

PURPOSE: The clinical and financial outcomes of an initial Medicare annual wellness visit (AWV) administered by a clinical pharmacist practitioner (CPP) in an academic internal medicine clinic are described. SUMMARY: As a result of the Patient Protection and Affordable Care Act, Medicare Part B allows for coverage of an AWV at no cost to eligible beneficiaries. The AWV is directed at health prevention, disease detection, and coordination of screening available to beneficiaries. CPPs are pharmacists who are recognized as advanced practice providers in the state of North Carolina and are authorized to administer AWVs. Eligible Medicare beneficiaries at least 65 years of age in an academic internal medicine clinic were mailed invitations to schedule an AWV. Patients who scheduled an AWV were mailed a packet to complete before the visit. During the visit, the packet was reviewed and interventions were made based on prespecified criteria derived from evidence-based medicine recommendations. After completion of the AWV, patients were provided with a detailed and individualized prevention plan. Between August 2011 and May 2012, 98 patients attended an AWV, all performed by the same CPP. The average time from check in to checkout for all patients was 73 minutes. The CPP made 441 interventions during these 98 visits, averaging 4.5 interventions per AWV completed. All initial AWVs were reimbursable up to a maximum of $159.38 per visit. CONCLUSION: A Medicare AMV administered by a CPP resulted in a wide variety of patient interventions and reimbursement for services provided.

Impact of genotype-guided dosing on anticoagulation visits for adults starting warfarin: a randomized controlled trial.

AIM: This study aimed to assess the effectiveness of genotype-guided warfarin dosing. PATIENTS & METHODS: A total of 109 adults were randomized to receive initial dosing as determined by an algorithm containing genetic (VKORC1 and CYP2C9) plus clinical information or only clinical information. Primary end points were the number of anticoagulation visits and the time in therapeutic range (TTR) over 90 days. Secondary end points included time to therapeutic dose, International Normalized Ratios of >4, emergency visits, hospitalizations, hemorrhagic events, thrombotic events and mortality. RESULTS: Neither primary end point was significantly different between groups (anticoagulation visits: 6.96 vs 6.37, p = 0.51; TTR: 0.40 vs 0.43, p = 0.59). Fewer emergency visits, hospitalizations, major hemorrhagic events, thrombotic events and deaths occurred in the genetic plus clinical group than in the clinical only group, but these differences were not statistically significant. CONCLUSION: Genotype-guided dosing did not decrease the number of anticoagulation visits or improve TTR. Our trial was not powered to detect anything but large differences for utilization and health outcomes.

Prospective study of supplemental vitamin K therapy in patients on oral anticoagulants with unstable international normalized ratios.

BACKGROUND: It is not known whether patients on oral vitamin K antagonists who have unstable INRs achieve more stable INRs with daily vitamin K supplementation. We sought to determine whether vitamin K supplementation may decrease INR variability in patients with a history of unstable INRs, how soon the INR decreases after vitamin K therapy is initiated, the time to reach a therapeutic INR after vitamin K initiation, and how much of an increase in oral anticoagulant dose is needed to maintain the INR in the desired range. METHODS: This is a prospective open label crossover study of patients on warfarin with a history of fluctuating INRs. A 9 week observation phase was followed by an 8 week period with patients receiving 500 microg of oral vitamin K daily. INRs were determined once weekly with a home point of care monitoring instrument. RESULTS: Vitamin K supplementation led to a decrease in INR variability in five of the nine patients studied (56%). INR decrease occurred 2-7 days after initiation of vitamin K. Therapeutic INRs were achieved 2-35 days after vitamin K therapy was initiated and an increase in warfarin dose of 6-95% was required to bring the INR back into the therapeutic range. CONCLUSIONS: INR fluctuations may decrease in selected patients with unstable INRs who receive vitamin K supplementation. A study with a larger sample size and longer follow-up period is needed. The results of the present study can help design such a study.