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The growing number of stroke survivors in the US, especially among women, makes understanding sex-specific trends in recurrent strokes crucial. Yet, such data are rare. We estimated 20-year sex-specific trends in recurrence in a population-based stroke study. Methods: We included first-ever ischemic strokes (IS) ascertained between January 1, 2000 and December 31, 2019 from the Brain Attack Surveillance in Corpus Christi (BASIC) Project in South Texas. Time to recurrence was calculated from first-ever IS to recurrence, death, or December 31, 2019, whichever came first. We estimated the cumulative incidence function (CIF) of recurrence by a multivariable Fine-Gray subdistribution hazard model, which accounted for the competing risk of death. An interaction term between calendar year and sex was used to generate 1-year and 5-year sex-specific trends in risks of recurrence between 2000-2019 from the fitted CIF. Results: Among the 5,752 IS (median age 69, 49.9% women), 786 (13.7%) had recurrences over a median of 7.6 years of follow-up and 2,653 (46.1%) died over a median of 3.7 years of follow-up. Women had significantly higher adjusted 1-year and 5-year risks of recurrence than men in 2000 (Figure). One-year and 5-year risk of recurrence declined in both sexes over time but women experienced larger declines such that the risks were similar between both sexes around 2009 but higher among men after that. The largest sex difference in recurrence was in the 5-year risk in 2000 with women having 5.0% (1.5%-8.4%) higher risk. Conclusions: The welcoming trends in recurrent strokes suggest successful secondary stroke prevention, especially in women, where greater declines were noted.

PURPOSE: Drug therapy for cancer is a high-risk, high-volume clinical intervention that requires interprofessional teams. Given the complexity of anticancer drug therapy and safety concerns, an interdisciplinary team developed a novel training program for oncology registered nurses and pharmacists to improve cancer drug safety. METHODS: Participants completed preworkshop learning assessments and received access to web-based modules on six topics: hazardous drug handling, drug extravasation, hypersensitivity reaction management, sepsis recognition, immune checkpoint inhibitor toxicities, and oral oncolytic adherence. In a 7-hour workshop, participants applied module content in interactive exercises and high-fidelity simulations. Preworkshop and postworkshop questionnaires assessed changes in knowledge and confidence in each topic. Program satisfaction and changes to clinical practice or policies were assessed 3 months after the workshop. RESULTS: Two hundred ninety-two nurses and 82 pharmacists applied to participate, and 103 (35%) and 44 (54%) have participated, respectively. Long-term follow-up data were available on 133 (90%) participants. Change scores in confidence to meet program objectives increased between pre- and postworkshop (range of increase 0.6-0.8, P < .01). Knowledge scores increased significantly between pre- and postworkshop (average improvement of 3.2 points, P < .01). Overall program satisfaction was high (mean 5.0, standard deviation [0.2] on a five-point scale). Seventy-seven (60%) reported that they had made at least one clinical practice or institutional policy change at 3 months. CONCLUSION: An interprofessional education program with online modules, in-person interactive sessions, and simulation activities is a promising strategy to deliver cancer drug safety content to practicing oncology clinicians.

Aim: We sought to understand how early adopters used pharmacogenomic (PGx) testing for treating depression and attention deficient hyperactivity disorder (ADHD). Patients & methods: We conducted a phone survey with prescribers who had previously ordered an Informed PGx (Progenity, Inc., MI, USA) test. Results: We identified 1037 prescribers in our sampling period. Respondents (n = 64) were predominantly female (61.5%) and in pediatrics (n = 42; 64.6%). PGx testing was used for multiple scenarios (mean 3.3 ± 1.6); the most common was after no response to medication was observed (80%; 51/64). Most respondents state that test results typically reveal an altered metabolizer status. Conclusion: PGx test results ordered by early adopters often reveal altered metabolizers which leads them to change the depression/ADHD medication regimen. Future work should evaluate the clinical utility of PGx testing for depression/ADHD treatment.

Purpose A focus on oral medications for patients receiving care from both oncologists and primary care providers elicits an opportunity for improvement in patient outcomes. The purpose of this pilot study was to explore the feasibility and appropriateness of a comprehensive medication review (CMR) by a primary care pharmacist in a population of patients with cancer and chronic conditions. Methods Adult patients who received both cancer and primary care at Michigan Medicine, received active systemic cancer treatment, and had a comorbid condition of diabetes, hypertension, chronic heart failure, depression, and/or anxiety were eligible to receive a CMR by the primary care clinical pharmacist. Data collected included number eligible for the CMR (feasibility), patient demographics, medication-related problems (MRPs) and medication interventions (appropriate), number of patients requiring follow-up with the clinical pharmacist or physician, and pre/post-intervention changes in A1c and BP, as applicable. Results Of the 96 patients that met inclusion criteria, 55 patients (57%) received a CMR. Pharmacists provided 66 instances of patient education and identified 22 medication-related problems (MRPs) in 15 (27%) of patients. After CMRs were completed, 22 patients (40%) were referred to primary care pharmacists or physician providers for ongoing care. Conclusion A CMR was feasible and appropriate for patients with chronic conditions receiving treatment for cancer.

BACKGROUND: Clinical services provided by pharmacists embedded in practices can improve patient outcomes within the primary care setting. Little is known about whether physician organizations (POs) will retain the services of clinical pharmacists after outside funding for a statewide implementation program is ended. OBJECTIVE: To evaluate a statewide program, Michigan Pharmacists Transforming Care and Quality (MPTCQ), that incorporated pharmacists within 17 POs. METHODS: A descriptive study was conducted using data collected from June 2016 to September 2018 from primary care clinical pharmacist encounters in POs participating in MPTCQ. Process outcomes included the number of participating POs, patient encounters, and average visits per patient. Analyses at the encounter level were stratified by 2 encounter types: disease state management (DSM) or comprehensive medication review (CMR). Separately by encounter type, pharmacist effect was described by the number, type, and reasons for medication changes, as well as medication adherence and cost barriers found and addressed. Clinical outcomes included hemoglobin A1c and blood pressure change. Sustainability and patient satisfaction of pharmacists providing clinical services are reported. RESULTS: Across 17 POs, 27 pharmacists participated in the MPTCQ program. Pharmacists completed 24,523 patient encounters for DSM with 5,942 patients, with an average of 5 visits per patient with diabetes and 2 visits for hypertension. Pharmacists made 15,153 therapeutic medication changes during visits for diabetes and hypertension, with approximately 70% related to efficacy. Pharmacists completed 4,203 CMR visits for 3,092 patients. During CMR visits, 1,296 therapeutic medication changes were recommended. Problems with medication cost were identified in 13% of CMR visits. Blood pressure and A1c levels decreased in patients managed by pharmacists. In 157 patients surveyed, 87% rated their pharmacists' care as excellent. Sixteen POs retained their pharmacists at the end of funding. CONCLUSIONS: A statewide provider-payer partnership successfully integrated and retained primary care pharmacists within POs. Pharmacists in the MPTCQ program contributed to improvements in disease control by changing medications to improve patient clinical outcomes. DISCLOSURES: Support for MPTCQ was provided by Blue Cross and Blue Shield of Michigan (BCBSM) as part of the BCBSM Value Partnerships program. Coe was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number KL2TR002241. Although BCBSM and MPTCQ work collaboratively, the opinions, beliefs, and viewpoints expressed by the authors do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors have no conflicts of interest to report.

To address the Quintuple Aim of health care improvement, the profession of pharmacy is on the verge of a practice transformation that incorporates continuous learning from medication-related data into existing clinical and dispensing roles. The pharmacists’ patient care process (PPCP) enables a learning pharmacy practice through the systematic and standardized collection of real-world medication-related data from pharmacists’ patient care activities. A learning pharmacy practice continually generates data-powered discoveries as a byproduct of PPCP interactions. In turn, these discoveries improve our medication knowledge while upgrading our predictive powers, thus helping all people achieve optimal health outcomes. Establishing a practice management system connected to the PPCP means that data are generated from every PPCP interaction, combined with existing data, and analyzed by teams of pharmacists and data scientists. The resulting new knowledge is then incorporated into all future PPCP interactions in the form of predictions coupled to actionable advice. The primary purpose of a learning pharmacy practice is to combine the power of predictive modeling with evidence-based best practices to achieve and sustain population-level health improvements. This purpose is achieved by systematically optimizing individual medication use in an equitable manner on a global scale.

Gang Fang,1 Stacy Cooper Bailey,2 Izabela E Annis,1 Michael K Paasche-Orlow,3 Michael S Wolf,2 Laurie T Martin,4 Michael Emch,5 M Alan Brookhart,6 Karen B Farris7 1Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 2Division of General Internal Medicine & Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; 3Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, USA; 4RAND Corporation, Arlington, VA, USA; 5Department of Geography and Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA; 6Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; 7College of Pharmacy, The University of Michigan, Ann Arbor, MI, USACorrespondence: Gang FangDivision of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, 2202, Kerr Hall, Chapel Hill, NC 27599-7573, USATel +1 919-966-7517Fax +1 919-966-8486Email gang_fang@unc.eduPurpose: Individual measures of health literacy are not feasible for administration on a large scale, yet estimates of community-level health literacy in the US recently became available. We sought to investigate whether community-level health literacy estimates are associated with the initiation of oral antihyperglycemic agents (OHA) and the use of standard preventive care services among older adults with newly diagnosed diabetes.Patients and methods: We conducted a retrospective cohort study of 169,758 patients, ≥65 years old with hypertension and newly diagnosed type 2 diabetes using 2007–2011 data from the Center for Medicare and Medicaid Services Chronic Conditions Warehouse. We examined the relationship between community-level health literacy estimates and initiation of OHA, receipt of flu shots, eye exams, Hemoglobin A1c tests, and lipid tests within 12 months post diabetes diagnosis.Results: Patients living in communities with above basic health literacy (vs. basic/below basic) were 15% more likely to initiate OHA (Hazard Ratio=1.15; 95% CI 1.12 to 1.18). After classifying the health literacy distribution as quintiles, the analysis revealed a dose–response relationship with OHA initiation that plateaued at the third and fourth quintiles and declined at the fifth quintile. Individuals residing in communities with higher health literacy were more likely to participate in preventive care services (relative risk ranged from 1.09 for lipid test [95% CI 1.07–1.11] to 1.43 for flu shot [95% CI 1.41–1.46]).Conclusion: Community-level health literacy estimates were associated with the initiation of OHA and uptake of standard preventive care services in older adults. Community-level health literacy may help to inform targeted diabetes education and support efforts.Keywords: health literacy, diabetes mellitus, adherence, preventive care

Purpose There are growing concerns about patients' adherence to oral anticancer agents (OAAs), and the need for patients to engage in self-management of OAA-related side effects. We assessed associations among adherence, severity of side effects, and effectiveness of self-management of side effects in patients taking capecitabine. Methods Adherence to capecitabine at 6 weeks was measured by the Medication Event Monitoring System among 50 patients with gastrointestinal cancers. Severity of side effects related to capecitabine and effectiveness of self-management of side effects were captured using the Modified Self-Care Diary at the time of enrollment and weekly for 6 weeks. Spearman's correlation, Mann-Whitney U-tests, and multiple linear regression were conducted, p Results Overall mean adherence rate was 85.4±14.1%. Adherence rate was not significantly correlated to the mean severity of total side effects at any time point and was correlated with the mean effectiveness of self-management of total side effects only at week 2 (rho=0.29, p=0.04). However, adherence rate was associated with the mean severity of one specific side effect, diarrhea, at 6 weeks (rho=0.36, p=0.01) and marginally correlated to the mean effectiveness of self-management of diarrhea at 6 weeks (rho=0.28, p=0.05). Mean severity of diarrhea at 6 weeks was an independent predictor of adherence rate (b=4.97, p=0.01), with the control of age (b=0.52, p=0.002), number of outpatient medications (b=1.12, p=0.007), health literacy (b=2.53, p=0.04), diagnosis of colorectal cancer (b=11.6, p=0.03), and capecitabine in combination with other chemotherapies (b=16.8, p=0.001) in the model. Conclusion This pilot study suggests ongoing examination of both severity and effectiveness of self-management of side effects in future studies of adherence to OAAs is merited. There is a need for future studies with larger sample sizes that explore the complex relationships among adherence, severity of side effects, and effectiveness of self-management of side effects in OAA therapy.

INTRODUCTION: The Medicare Part D medication therapy management (MTM) program positions pharmacists to optimize beneficiaries’ medications and improve care. Little is known regarding Part D MTM delivery by community pharmacists and other pharmacist provider types. OBJECTIVES: To (1) characterize Medicare Part D MTM delivery by community pharmacists, (2) compare MTM delivery by community pharmacists to other pharmacists, and (3) generate hypotheses for future research. METHODS: A descriptive cross-sectional study using merged data from a 20% random sample of Medicare beneficiary enrollment data with a 100% sample of recently available 2014 Part D MTM files was conducted. Andersen’s Behavioral Model was applied to describe MTM delivery across beneficiary characteristics. Descriptive and bivariate statistics were used to compare delivery of MTM between community and other pharmacist providers. RESULTS: Among beneficiaries sampled, community pharmacists provided comprehensive medication reviews (CMRs) to 22% (n=26,337) of beneficiaries receiving at least one CMR. Almost half (49.4%) were provided face-to-face. Across pharmacist cohorts, median days to CMR offer of post-MTM program enrollment were within the 60-day policy requirement. The community pharmacist cohort had fewer days from CMR offer to receipt (median 47 days). Community pharmacists provided more medication therapy problem (MTP) recommendations (mean [SD] of 1.8 [3.5]; p

OBJECTIVES: Race differences in contraceptive use and in geographic access to pharmacies are well established. We explore race differences in characteristics of nearby pharmacies that are likely to facilitate (or not) contraceptive purchase. STUDY DESIGN: We conducted analyses with two geocode-linked datasets: (1) the Relationship Dynamics and Social Life (RDSL) project, a study of a random sample of 1,003 women ages 18–19 living in a county in Michigan in 2008–09; and (2) the Community Pharmacy Survey, which collected data on 82 pharmacies in the county in which the RDSL study was conducted. RESULTS: Although young African-American women tend to live closer to pharmacies than their white counterparts (1.2 miles to the nearest pharmacy for African Americans vs. 2.1 miles for whites), those pharmacies tend to be independent pharmacies (43% vs. 12%) that are open fewer hours per week (64.6 vs. 77.8) and have fewer female pharmacists (17% vs. 50%), fewer patient brochures on contraception (2% vs. 5%), more difficult access to condoms (49% on the shelf vs. 85% behind glass, behind the counter, or not available), and fewer self-check-out options (3% vs. 9%). More African-American than white women live near African-American pharmacists (8% vs. 3%). These race differences are regardless of poverty, measured by the receipt of public assistance. CONCLUSIONS: Relative to white women, African-American women may face a “contraception desert,” wherein they live nearer to pharmacies, but those pharmacies have characteristics that may impede the purchase of contraception.

Aim: We sought to explore how early adopters use pharmacogenomic (PGx) testing for treating depression and attention-deficit/hyperactivity disorder. Patients & methods: Prescribers of the Informed PGx (Progenity, Inc., Ann Arbor, MI 48108, USA) test completed a phone survey assessing use of PGx testing for different scenarios. We conducted a qualitative thematic text analysis of transcribed audio recordings of open-ended responses (n = 62). Results: PGx testing was used when treating multiple comorbidities or resistant disease, and to ease patients’ concerns with future therapy. Use of PGx testing is influenced by insurance coverage, interpretability of results and results turnaround time. Conclusion: Prescribers used PGx tests to modify medications for complex patients with depression, attention-deficit/hyperactivity disorder and other disorders to alleviate concerns related to adverse effects and lack of effectiveness.

Purpose: ASCO has worked to facilitate the improvement in quality oncology care via the development of the Quality Oncology Practice Initiative (QOPI). The extent to which the ASCO QOPI identifies areas in which pharmacists may enhance care is not known. These findings are important, as pharmacists are an integral part of the care team, providing direct clinical care in addition to medication use guidelines and practice-based policies. In addition, high-performing practices may receive reimbursement from the Centers for Medicare and Medicaid Services. Methods: Three pharmacists reviewed 200 QOPI measures for potential pharmacist involvement. We used the Hematology/Oncology Pharmacy Association Scope of Practice document and a validated summary of services provided by board-certified oncology pharmacists to identify which practice domains and pharmacy services would best fit the care provided by the selected QOPI measures. Results: A total of 177 QOPI measures were analyzed. Potential areas of pharmacist impact were identified in 67 (38%) of the included metrics. Measures largely related to optimizing drug therapy through the development and implementation of pharmacy guidelines. Patient counseling and symptom management are services that best described the majority of QOPI measures deemed actionable by a pharmacist. We also found that several QOPI measures pharmacists can intervene upon overlap with metrics currently assessed for reimbursement via the Centers for Medicare and Medicaid Services Merit-Based Incentive Payment System. Conclusion: Oncology pharmacists are uniquely positioned to improve the quality of care provided to patients with cancer within the team-based setting.

Background: Although paclitaxel remains one of the most efficacious and commonly used agents in the treatment of breast cancer, it can cause a number of side effects. Decisions to delay, decrease, or discontinue treatment are made based on the severity of chemotherapy induced peripheral neuropathy (CIPN), which is not objectively measured but relies on patient's accurately reporting symptoms to their clinical team. There is some concern that patients do not accurately or completely report CIPN symptoms during treatment. A previous study reported that 3 of 24 patients (12.5%) considered or could understand another patient's decision to under-report CIPN symptoms to avoid treatment disruption. The objective of this follow-up study was to determine whether under-reporting occurred and to understand patient perspectives on topics previously found relevant to a patient's decision to under-report CIPN. Methods: Ten patients with early stage breast cancer who received adjuvant paclitaxel 80 mg/m2 for up to 12 weeks, who had no prior neuropathy or neurotoxic chemotherapy participated in a recorded, semi-structured, phone-based interview that followed an interview guide designed to cover topics relevant to patient under-reporting Themes identified in patient perceptions of objectives found relevant to under reportingObjectiveResultPatient Understanding1. Patients had consistent descriptions of their expectations for CIPN prior to treatment. 2. Understanding of the long-term potential of CIPN varied among patients.Patient Education1. Patients used a variety of sources to find information about CIPN, with the most commonly used sources being medical staff and patient handouts.Patient Input1. Patients agree on the importance of reporting side effects, but not to what extent. 2. Patients felt included in the treatment decision-making process, but some felt the doctor ultimately made the decision. 3. Providers may plan an important role in the extent to which patients report their symptoms.Treatment Cycles1. Patients recognized that they may not complete all 12 cycles, but were determined to do so.Perception Changes1. Before treatment, patients are much more focused on efficacy and were not particularly concerned with side effects. 2. During treatment, patients reflected on their desire to complete treatment and the tolerability of the side effects they were experiencing. 3. After treatment, patients felt they should have asked more questions before starting treatment. . The interviews were then transcribed and qualitatively analyzed using NVivo software to identify common themes. Results: No patients in this study admitted to under-reporting neuropathy. Themes that emerged from the interviews are presented in Table 1. Conclusion: Insight as to how patients perceive various aspects of paclitaxel treatment revealed that comfort level with providers, inclusion in the decision-making process, and encouragement to fully disclose all symptoms played an important role when patients considered whether to report adverse effects. Future research may focus on whether a lack of health literacy and/or health care related work experience predisposes to CIPN under-reporting. Citation Format: Hertz DL, Krumbach E, Nobles B, Erickson S, Farris KB. The role of patient perceptions in under reporting chemotherapy induced peripheral neuropathy (CIPN) [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-11-06.

Background The successful management of heart failure (HF) involves guideline-based medical therapy as well as self-management behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. Objective The aim of this paper was to evaluate the efficacy of enhanced self-management via a mobile app intervention on health-related quality of life, self-management, and HF readmissions. Methods A single-center randomized controlled trial was performed. Participants older than 45 years and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group (“app group”) used a mobile app, and the intervention prompted daily self-monitoring and promoted self-management. The control group (“no-app group”) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire score and recurrent HF admissions. Results A total of 83 participants were enrolled and completed all baseline assessments. Baseline characteristics were similar between the groups except for the prevalence of ischemic HF. The app group had a reduced MLHFQ at 6 weeks (mean 37.5, SD 3.5 vs mean 48.2, SD 3.7; P=.04) but not at 12 weeks (mean 44.2, SD 4 vs mean 45.9, SD 4; P=.78), compared to the no-app group. There was no effect of the app on the SCHFI at 6 or 12 weeks. The time to first HF readmission was not statistically different between the app group and the no-app group (app group 11/42, 26% vs no-app group 12/41, 29%; hazard ratio 0.89, 95% CI 0.39-2.02; P=.78) over 12 weeks. Conclusions The adaptive mobile app intervention, which focused on promoting self-monitoring and self-management, improved the MLHFQ at 6 weeks but did not sustain its effects at 12 weeks. No effect was seen on HF self-management measured by self-report. Further research is needed to enhance engagement in the app for a longer period and to determine if the app can reduce HF readmissions in a larger study. Trial Registration ClinicalTrials.gov NCT03149510; https://clinicaltrials.gov/ct2/show/NCT03149510

PURPOSE: Cases of chemotherapy-induced peripheral neuropathy (CIPN) under-reporting have been sporadically described in the literature, but no studies have focused on actively examining this behavior. Our primary aim was to identify women who purposefully under-reported CIPN, along with reasons for doing so. A secondary aim was to explore factors enabling or hindering communication of CIPN to clinicians. METHODS: Semi-structured interviews were conducted with women with breast cancer who had received paclitaxel in a prospective observational study. The interview guide was developed based on factors hypothesized to influence side effect disclosure to clinicians. Interviews were recorded, transcribed verbatim, and thematically content analyzed. RESULTS: Thirty-four women were interviewed. Three main themes emerged from the analysis: 1) enablers of CIPN reporting (e.g., positive relationships with the oncology team, sufficient appointment time, existence of alternative communication channels to office visits, expectation of CIPN as a side effect); 2) deterrents to CIPN reporting (e.g., perception of need to complete the full course of therapy, fear of treatment discontinuation, lack of knowledge of long-term consequences of CIPN); and 3) balancing survival versus functional impairment due to CIPN. Women prioritized efficacy over CIPN until physical functioning was meaningfully affected. No patients reported purposeful CIPN under-reporting, but three women admitted having considered doing so. CONCLUSIONS: Despite the lack of evidence of CIPN withholding, women considered both the effectiveness and the toxicity of paclitaxel treatment, as well as beliefs about treatment and long-term consequences of CIPN and relationship with the oncology team, when deciding whether to report CIPN symptoms.

The appropriateness of term limits for administrative appointments is a subject of much discussion, not just within pharmacy programs, but in organizations of all types. The prospect of term limits for involves a wide variety of important organizational issues, including succession planning, institutional memory, strategic decision-making, and concepts regarding leadership styles overall. This paper examines both sides of the debate regarding the appropriateness of term limits for administrative appointments. Arguments supporting term limits include the ability for strategic changes in the diversity of leaders as well as a more focused effort on continuous quality improvement. The arguments against term limits focus around the need for stability and the time involved in the development of effective leaders.

Purpose Discrepancies between clinicians’ assessment of chemotherapy-induced peripheral neuropathy (CIPN) and patient-reported outcomes (PRO) have been described, though the underlying reasons are unknown. Our objective was to identify potential patient-specific factors associated with under-describing of CIPN to clinicians in women with non-metastatic breast cancer treated with paclitaxel. Methods Patients enrolled in an observational study (n = 60) completed weekly CIPN PRO using the EORTC CIPN20. Clinician-documented CIPN using the NCI CTCAE were abstracted from the electronic medical record and paired with CIPN20 data at weeks 7 and 10. Patients were classified as under-describers if their CIPN20 was above the 80th percentile of the CIPN20 distribution for that CTCAE grade from an independent clinical trial (N08CA). Demographics, Assessment of Survivor Concerns (ASC), Trust in Oncologist Scale (TiOS), and health literacy assessment were collected post-treatment via survey. Repeated measures cumulative logistic regression models were used to identify factors associated with under-describing CIPN. Results Forty-two women completed the survey (response rate 70%). Three and 9 patients were categorized as under-describers at weeks 7 and 10, respectively. Women who were not working (OR = 9.00, 95%CI 1.06–76.15), had lower income (OR = 7.04, 95%CI 1.5–32.99), and displayed higher trust in their oncologist’s competence (OR = 1.29, 95%CI 1.03–1.62 for a 0.1-unit increase in score) were more likely to under-describe CIPN symptoms. Conclusions This preliminary study identified non-working status, low income and trust in oncologist’s competence as potential factors influencing under-description of CIPN to the clinical team. Further work is needed to clarify these relationships and test additional factors., Highlights • This pilot study examined factors associated with under-describing of neuropathy. • Patient-reported and clinician-documented neuropathy severity were compared. • Non-working status and low income were associated with neuropathy under-describing. • Trust in oncologist’s competence was associated with neuropathy under-describing. • Recording patient-clinician interactions would confirm under-describing behavior.

Background Medicare Part D medication therapy management (MTM) includes an annual comprehensive medication review (CMR) as a strategy to mitigate suboptimal medication use in older adults. Objectives To describe the characteristics of Medicare beneficiaries who were eligible, offered, and received a CMR in 2013 and 2014 and identify potential disparities. Methods This nationally representative cross-sectional study used a 20% random sample of Medicare Part A, B, and D data linked with Part D MTM files. A total of 5,487,343 and 5,822,188 continuously enrolled beneficiaries were included in 2013 and 2014, respectively. CMR use was examined among a subset of 620,164 and 669,254 of these beneficiaries enrolled in the MTM program in 2013 and 2014. Main measures were MTM eligibility, CMR offer, and CMR receipt. The Andersen Behavioral Model of Health Services Use informed covariates selected. Results In 2013 and 2014, 505,658 (82%) and 649,201 (97%) MTM eligible beneficiaries were offered a CMR, respectively. Among those, CMR receipt increased from 81,089 (16%) in 2013 to 119,181 (18%) in 2014. The mean age of CMR recipients was 75 years (±7) and the majority were women, White, and without low-income status. In 2014, lower odds of CMR receipt were associated with increasing age (adjusted odds ratio (OR) = 0.99 (95% confidence interval (CI) = 0.994–0.995), male sex (OR = 0.93, 95% CI = 0.926–0.951), being any non-White race/ethnicity except Black, dual-Medicaid status (OR = 0.64, 95% CI = 0.626–0.650), having a hospitalization (OR = 0.87, 95% CI = 0.839–0.893) or emergency department visit (OR = 0.67, 95% CI = 0.658–0.686), and number of comorbidities (OR = 0.90, 95% CI = 0.896–0.905). Conclusions CMR offers and completion rates have increased, but disparities in CMR receipt by age, sex, race, and dual-Medicaid status were evident. Changes to MTM targeting criteria and CMR offer strategies may be warranted to address disparities.

BACKGROUND Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. OBJECTIVE The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. METHODS We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. RESULTS We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. CONCLUSIONS This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care. CLINICALTRIAL ClinicalTrials.gov NCT03270891; https://clinicaltrials.gov/ct2/show/NCT03270891 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR1-10.2196/13848

Background Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. Objective The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. Methods We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. Results We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. Conclusions This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care. Trial Registration ClinicalTrials.gov NCT03270891; https://clinicaltrials.gov/ct2/show/NCT03270891 International Registered Report Identifier (IRRID) RR1-10.2196/13848

Background Text messages can improve medication adherence and outcomes in several conditions. For this study, experts developed text messages addressing determinants of medication adherence: disease beliefs, medication necessity, medication concerns, and forgetfulness, as well as positive reinforcement messages for patients who were adherent. Objectives To validate expert-developed text messages to address medication non-adherence with a group of non-researchers. Methods A two-wave, card-sorting activity was conducted with students and staff at the University of Michigan. In the first wave, 40 participants grouped 32 messages addressing barriers for medication adherence (disease beliefs, medication necessity, medication concerns, and forgetfulness) according to their perceived relationship. Messages with poor grouping agreement were deleted or modified. In the second wave, positive reinforcement messages were developed and tested along with the previous categories (36 messages) by 37 participants. Similarity and cluster analyses were used to assess agreement between experts and participants. Results In the first card-sorting wave, participants grouped messages into between 2 and 13 separate categories. Similarity analysis showed four groupings of messages, however, some had an agreement below 50% and clusters appeared dispersed. In the second wave, and after messages being edited, participants grouped the messages into between 4 and 9 categories. Five groups (now including positive reinforcement messages) were identified with higher agreement in the similarity and cluster analyses. Conclusions The structure of expert-developed text messages to address medication adherence key barriers was confirmed. Messages will be used in future research to determine their impact on affecting medication adherence to anti-hypertensive medications using a reinforcement learning controlled text messaging service.

Purpose: The shift from infusion to oral oncolytic therapy presents challenges to oncology practitioners. The purpose of this study was to describe how a statewide quality-improvement collaborative can enhance quality of care for patients receiving oral oncolytic therapy. Methods: The Michigan Oncology Quality Consortium hosted a series of learning sessions focused on oral oncolytic quality improvement, providing multiple resources to oncology community practices. The first five participating practices reported which of the evidence-based Michigan Oncology Quality Consortium resources provided were implemented at their site. They also performed prepost self-assessments in October 2013 and April 2015 and another in December 2017 to assess sustainability. Concordance with the ASCO Quality Oncology Practice Initiative oral chemotherapy standards, including documentation (five measures), patient education (seven measures), and follow-up/monitoring (four measures), was compared. Results: All practices showed improvement between 2013 and 2015 in documentation (32% to 88%; P = .03), patient education (37% to 100%; P could not be calculated), and monitoring (40% to 80%; P > .2). Overall, a significant improvement in concordance was observed (36% to 91%; P = .03). Use of resources from each practice varied, and practices that used more resources showed greater improvements. There was a slight decrease in overall concordance between 2015 and 2017, which was not found to be significant (91% to 84%; P = .53). Conclusion: Use of tools from a quality-improvement collaborative improved concordance with national standards of care. Large-scale deployment of this model program may provide a clinically efficient and effective mechanism to enhance widespread change.

Purpose To assess longer-term patterns of glaucoma medication adherence and identify whether patterns established during the first year of medication use persist during 3 subsequent years of follow-up. Design Retrospective, longitudinal cohort analysis. Participants Beneficiaries aged ≥40 years who were enrolled in a United States (US)-managed care plan for ≥7 years between 2001 and 2012 and newly diagnosed and treated for open-angle glaucoma. Methods For each enrollee, we quantified medication adherence using the medication possession ratio. Group-based trajectory modeling (GBTM) was applied to identify patterns of adherence for 1 and 4 years of follow-up. The percent of beneficiaries who remained in the same trajectory group in the 1- and 4-year models was tabulated to evaluate group stability. Factors impacting adherence at 1 and 4 years were identified using regression analyses. Main Outcome Measures Patterns of glaucoma medication adherence. Results Of the 1234 eligible beneficiaries, GBTM identified 5 distinct glaucoma medication adherence patterns in both the 1-year and 4-year follow-up periods. These groups were as follows: (1) never adherent after their index prescription fill (7.5% and 15.6% of persons in the 1- and 4-year models, respectively); (2) persistently very poor adherence (14.9% and 23.4% of persons in the 1- and 4-year models, respectively); (3) declining adherence (9.5% and 9.1% of persons in the 1- and 4-year models, respectively); (4) persistently moderate adherence (48.1% and 37.0% of persons in the 1- and 4-year models, respectively); and (5) persistently good adherence (20.0% and 15.0% of persons in the 1- and 4-year models, respectively). More than 90% of beneficiaries in the 4 groups with the worst and best adherence patterns (groups 1, 2, 3, 5) maintained their patterns from their first year throughout their 4 years of follow-up. Those with persistently moderate adherence (group 4), the largest group, were most likely to change groups from 1 to 4 years of follow-up. Persons with the best adherence over 4 years were more likely to be white, to be older, to earn >$60 000/year, and to have more eye care visits ( P P = 0.03). Conclusions For most patients who were newly prescribed glaucoma medications, adherence patterns observed in the first year of treatment reflect adherence patterns over the subsequent 3 years. Investing resources in both identifying and helping patients with suboptimal adherence patterns over the first year may have a large impact on longer-term adherence.

OBJECTIVE: The temporal component of medication adherence is important while designing interventions to improve medication adherence. Thus, the objective of this study was to determine how medication adherence and beliefs in medicines change over time in older adults. METHODS: A two-year longitudinal internet-based survey among adults 65+ years was used to collect data on medication adherence (Morisky 4-item scale) and beliefs in medicines (Beliefs about Medicines Questionnaire). Paired t-test and one-way ANOVA determined if a change in beliefs in medicines and medication adherence over time was significant. A multiple linear regression was used to determine the significant predictors of change in medication adherence over time. RESULTS: 436 respondents answered both baseline and follow-up surveys. Among all respondents, there was no significant change in adherence (0.58 ± 0.84 vs. 0.59 ± 0.84; p > 0.05), necessity beliefs (17.13 ± 4.31 vs. 17.10 ± 4.29; p > 0.05), or concern beliefs (11.70 ± 3.73 vs. 11.68 ± 3.77; p > 0.05) over time. For older adults with lower baseline adherence, there was a statistically significant improvement in adherence (1.45 ± 0.70 vs. 0.99 ± 0.97; p < 0.05); but no change in beliefs in medicines over time. The significant predictors of change in medication adherence over time were baseline adherence and baseline concern beliefs in medicines. CONCLUSION: With baseline adherence and baseline concern beliefs in medicines playing a significant role in determining change in adherence behavior over time, especially in individuals with lower adherence, it is important to alleviate medication concerns at the beginning of therapy for better adherence.

Purpose To evaluate the frequency of 11 commonly cited barriers to optimal glaucoma medication adherence among glaucoma patients and to identify barriers contributing to poor adherence. Design Prospective, cross-sectional survey. Participants One hundred ninety adults with glaucoma taking 1 or more glaucoma medication who received care in glaucoma clinics in Ann Arbor, Michigan, and Baltimore, Maryland. Methods Participants completed a survey on demographic and disease characteristics, barriers to optimal glaucoma medication adherence, interest in an eye drop aid, and self-reported adherence (measured by the Morisky Adherence Scale). Descriptive statistics and logistic regression analyses were performed. Main Outcome Measures Frequency and number of barriers to adherence among both adherent and nonadherent patients. Odds ratios (ORs) with 95% confidence intervals (CIs) identifying barriers associated with poor adherence. Results Twenty-seven percent of the sample reported poor adherence. Sixty-one percent of all participants cited multiple barriers and 10% cited a single barrier as impediments to optimal adherence. Twenty-nine percent of subjects cited no barriers, although only 13% of patients who cited no barriers were nonadherent. Among nonadherent patients, 31% or more cited each of the 11 barriers as important. Logistic regression analysis, adjusted for age, revealed that the following barriers were associated with higher odds of nonadherence: decreased self-efficacy (OR, 4.7; 95% CI, 2.2–9.7; P ≤ 0.0001), difficulty instilling drops (OR, 2.3; 95% CI, 1.1–4.9; P = 0.03), forgetfulness (OR, 5.6; 95% CI, 2.6–12.1; P ≤ 0.0001), and difficulties with the medication schedule (OR, 2.9; 95% CI, 1.4–6.0; P = 0.006). For each additional barrier cited as important, there was a 10% increased odds of being nonadherent (OR, 1.1; 95% CI, 1.0–1.2; P = 0.01). Conclusions Each of the 11 barriers was important to at least 30% of surveyed patients with poor adherence, with most identifying multiple barriers to adherence. Low self-efficacy, forgetfulness, and difficulty with drop administration and the medication schedule were barriers associated with poor adherence. Interventions to improve medication adherence must address each patient's unique set of barriers.

The type 2 diabetes epidemic is a global health issue, and it is especially severe in the US Pacific. Although there are nutrition interventions in Hawaii and the Pacific, success is limited, in part, because of the lack of tailoring for the Pacific context. The Pacific context is inclusive of environment, political, and economic situation; historical (precontact, colonial, and post colonial) background; cultural practices; and spiritual orientation. This study used Grounded Theory and Community-Based Participatory Research processes to identify influences that hinder or facilitate adherence to nutrition recommendations. Data were gathered through key informant interviews (faith leaders and health care providers) and focus-group discussions (individual with diabetes and care takers). Results showed barriers to nutrition recommendations adherence that were similar to other minority populations in the United States, such as cost of healthy foods, taste preference, low availability of healthy food choices, lack of ideas for healthy meals/cooking, and lack of culturally appropriate options for dietary modification. It also elucidated behaviors that influence adherence to nutrition recommendations, such as preparing and consuming meals for and with extended family and church members; patient and group motivation; and access to healthy, affordable, and palatable foods. Participants expressed the need for interventions that are tailored to the local culture and context and a holistic view of health, with a focus on motivation (spiritual and emotional support). These findings could be used to develop culturally and contextually appropriate programs. For example, adapting motivational interviewing techniques and materials by adding family members to motivational interviewing sessions vs patients only, as Pacific Islanders have a collectivistic culture and family members play an important role in adherence; conducting motivational interviewing in the community in addition to the clinical setting; utilizing church leaders as motivational interviewing counselors in addition to health care providers; and changing motivational interviewing narratives and tools (eg, a confidence scale of 1 to 10 will be unfamiliar to many Pacific Islanders); therefore, counselors need to develop another method to indicate levels of confidence, such as the color of the lagoon/ocean that goes from turquoise (the color of shallow water) to navy blue (the color of deep water).

The objective of this study was to determine if a Web application that promoted mindfulness of the progress of the chronic disease through self-monitoring improved quality of life in heart failure.This was a prospective single-center single-group study. Participants were instructed how to use the Web application and to perform self-monitoring daily for 12 weeks. A comprehensive physical exam, assessment of New York Heart Association (NYHA) class, the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and an evaluation of self-management were performed in person at baseline and at 12 weeks.Participants consisted of older (mean, 59 years), predominantly female (63%) adults with NYHA class II or III symptoms. NYHA classification (preintervention versus postintervention, 2.5±0.13 versus 2.0±0.13; p=0.0032) and MLHFQ score (55.7±4.6 versus 42.6±5.1, respectively; p=0.0078) improved over 12 weeks of self-monitoring. A trend toward improvement was also demonstrated in weight (preintervention versus postintervention, 209±9.6 pounds versus 207±9.4 pounds; by paired t test, p=0.389), number of times exercised per week (1.29±0.5 versus 2.5±0.6, respectively; p=0.3), and walk distance (572±147 yards versus 845±187 yards, respectively; p=0.119). Jugular venous distention (preintervention versus postintervention, 8.1±0.6 cm versus 6.7±0.3 cm; p=0.083) and peripheral edema (29.2% versus 16.7%, respectively; p=0.375) decreased after 12 weeks of self-monitoring via the Web application.A Web application for self-monitoring heart failure over 12 weeks improved both NYHA classification and MLHFQ score. The trend in improved physical activity and physical exam support these outcomes. The number of patients reporting a sodium-restricted diet increased over the 12 weeks, which may have led to the positive findings.

BACKGROUND Smartphone apps can be a tool to facilitate independent medication management among persons with developmental disabilities. At present, multiple medication management apps exist in the market, but only 1 has been specifically designed for persons with developmental disabilities. Before initiating further app development targeting this population, input from stakeholders including persons with developmental disabilities, caregivers, and professionals regarding the most preferred features should be obtained. OBJECTIVE The aim of this study was to identify medication management app features that are suitable to promote independence in the medication management process by young adults with developmental disabilities using a Delphi consensus method. METHODS A compilation of medication management app features was performed by searching the iTunes App Store, United States, in February 2016, using the following terms: adherence, medication, medication management, medication list, and medication reminder. After identifying features within the retrieved apps, a final list of 42 features grouped into 4 modules (medication list, medication reminder, medication administration record, and additional features) was included in a questionnaire for expert consensus rating. A total of 52 experts in developmental disabilities, including persons with developmental disabilities, caregivers, and professionals, were invited to participate in a 3-round Delphi technique. The purpose was to obtain consensus on features that are preferred and suitable to promote independence in the medication management process among persons with developmental disabilities. Consensus for the first, second, and third rounds was defined as ≥90%, ≥80%, and ≥75% agreement, respectively. RESULTS A total of 75 responses were received over the 3 Delphi rounds—30 in the first round, 24 in the second round, and 21 in the third round. At the end of the third round, cumulative consensus was achieved for 60% (12/20) items in the medication list module, 100% (3/3) in the medication reminder module, 67% (2/3) in the medication administration record module, and 63% (10/16) in the additional features module. In addition to the medication list, medication reminder, and medication administration record features, experts selected the following top 3 most important additional features: automatic refills through pharmacies; ability to share medication information from the app with providers; and ability to share medication information from the app with family, friends, and caregivers. The top 3 least important features included a link to an official drug information source, privacy settings and password protection, and prescription refill reminders. CONCLUSIONS Although several mobile apps for medication management exist, few are specifically designed to support persons with developmental disabilities in the complex medication management process. Of the 42 different features assessed, 64% (27/42) achieved consensus for inclusion in a future medication management app. This study provides information on the features of a medication management app that are most important to persons with developmental disabilities, caregivers, and professionals.

Despite the value of emergency contraception (EC) in reducing unintended pregnancy, use in college women has not been widely studied. This exploratory descriptive study, using a web-based survey, described knowledge and use of EC in 2,007 college women and identified associations between selected personal characteristics and EC use. Most women (72.2%) knew EC could be obtained over the counter and was most effective within 72 hr of intercourse (93%). Women inaccurately thought EC was effective through the first trimester of pregnancy (87.1%) and could cause birth defects (27.8%). Among sexually active women, 37% reported use. Experiencing a false alarm pregnancy, knowing that EC was available over the counter, and being Asian/Pacific Islander were positively associated with use. Additional studies should explore the utility of EC in other populations and efforts should be stepped up to provide accurate information about access and mechanism of use.

Background Mobile health (mHealth) services cannot easily adapt to users’ unique needs. Purpose We used simulations of text messaging (SMS) for improving medication adherence to demonstrate benefits of interventions using reinforcement learning (RL). Methods We used Monte Carlo simulations to estimate the relative impact of an intervention using RL to adapt SMS adherence support messages in order to more effectively address each non-adherent patient’s adherence barriers, e.g., forgetfulness versus side effect concerns. SMS messages were assumed to improve adherence only when they matched the barriers for that patient. Baseline adherence and the impact of matching messages were estimated from literature review. RL-SMS was compared in common scenarios to simple reminders, random messages, and standard tailoring. Results RL could produce a 5–14 % absolute improvement in adherence compared to current approaches. When adherence barriers are not accurately reported, RL can recognize which barriers are relevant for which patients. When barriers change, RL can adjust message targeting. RL can detect when messages are sent too frequently causing burnout. Conclusions RL systems could make mHealth services more effective. Electronic supplementary material The online version of this article (doi:10.1007/s12160-014-9634-7) contains supplementary material, which is available to authorized users.

Introduction Heart failure (HF) is the most common hospital discharge diagnosis among older adults. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. Hypothesis Our hypothesis was that a patient-centered mobile application, ManageHF, would reduce Minnesota Living with Heart Failure Questionnaire (MLHFQ) at 6 and 12 weeks post-hospital discharge compared to usual care. Methods A single-center randomized controlled trial was performed. Patients were included if they were greater than 45 years of age, had a left ventricular ejection fraction (LVEF) 40% (with LA size >40 mm or BNP > 200 pg/ml or NT-proBNP > 800 pg/ml) and were currently admitted or recently discharged for acute on chronic decompensated HF. Patients were excluded for any of the following: unstable coronary syndromes within 8 weeks, primary valvular heart disease, constrictive pericardial disease, uncorrected thyroid disease, dialysis or creatinine >4.0 mg/dL, a hospice candidate, active cancer, pulmonary fibrosis, discharged to a setting other than home, or required a chronic inotrope. The intervention group used a mobile application, ManageHF, along with a Fitbit wearable and scale. The mobile application prompted active self-monitoring and provided a health status indicator to promote self-management. The control group received usual care. The primary outcome was the change in MLHFQ from baseline to 6 and 12 weeks using mixed models. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and HF admissions. Results Eighty-two patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF type. The intervention group had a reduced MLHFQ at 6 weeks (p=0.026) but not at 12 weeks (p=0.61) compared to control (Figure). There was no effect of the intervention on the SCHFI or any of its subcomponents at 6 or 12 weeks. The time to first HF admission was not statistically different between the two groups (HR 0.85, 95% CI 0.36-2.0, p=0.71). Median number of days the intervention group performed self-monitoring was 63 days. Conclusion ManageHF improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on self-care measured by SCHFI. Further research is needed to enhance engagement in the app for a longer period of time and to determine if the app can reduce HF admissions in a larger study.

Purpose To examine the impact of a personal health record (PHR) on medication-use safety among older adults. Background Online PHRs have potential as tools to manage health information. We know little about how to make PHRs accessible for older adults and what effects this will have. Methods A PHR was designed and pretested with older adults and tested in a 6-month randomized controlled trial. After completing mailed baseline questionnaires, eligible computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or serve as a standard care control group (n=273). Follow-up questionnaires measured change from baseline medication use, medication reconciliation behaviors, and medication management problems. Results Older adults were interested in keeping track of their health and medication information. A majority (55.2%) logged into the PHR and used it, but only 16.1% used it frequently. At follow-up, those randomized to the PHR group were significantly less likely to use multiple non-steroidal anti-inflammatory drugs—the most common warning generated by the system (viewed by 23% of participants). Compared with low/non-users, high users reported significantly more changes in medication use and improved medication reconciliation behaviors, and recognized significantly more side effects, but there was no difference in use of inappropriate medications or adherence measures. Conclusions PHRs can engage older adults for better medication self-management; however, features that motivate continued use will be needed. Longer-term studies of continued users will be required to evaluate the impact of these changes in behavior on patient health outcomes.

Purpose The effect of hospital pharmacists’ enhanced communication with patients and community providers on the underutilization of key cardiovascular medications was studied. Methods Patients enrolled in the Iowa Continuity of Care study were eligible for inclusion in this study if they had a diagnosis of hypertension, hyperlipidemia, heart failure, coronary artery disease, or a combination of these diagnoses. Eligible patients also had to be admitted to the internal medicine, family medicine, cardiology, or orthopedics services and receive their usual medical care in the community and their prescriptions from a community pharmacy. Patients were randomized to receive minimal intervention, enhanced intervention, or usual care. For the minimal- and enhanced-intervention groups, pharmacy case managers (PCMs) performed comprehensive medication reconciliations and identified drug-related problems within 24 hours of admission. The PCMs made recommendations to the inpatient care team and to patients’ community physicians. For patients in the enhanced-intervention group, the PCM developed a discharge care plan containing the patient’s discharge medication list. PCMs made specific recommendations to optimize regimens that did not meet current guidelines or medications that were underutilized. Medication underutilization was assessed at admission, discharge, 30 days after discharge, and 90 days after discharge. Results A total of 732 patients were enrolled in this study. There were no significant differences among the three study groups. Overall, the rate of underutilization remained constant among all three groups, despite enhanced pharmacist involvement in both intervention groups. Conclusion Enhanced interventions by PCMs had no effect on the underutilization of key cardiovascular drugs during hospitalization or after hospital discharge.

Background: Cognitive behavioral therapy (CBT) is one of the most effective treatments for chronic low back pain. However, only half of Department of Veterans Affairs (VA) patients have access to trained CBT therapists, and program expansion is costly. CBT typically consists of 10 weekly hour-long sessions. However, some patients improve after the first few sessions while others need more extensive contact. Objective: We are applying principles from “reinforcement learning” (a field of artificial intelligence or AI) to develop an evidence-based, personalized CBT pain management service that automatically adapts to each patient’s unique and changing needs (AI-CBT). AI-CBT uses feedback from patients about their progress in pain-related functioning measured daily via pedometer step counts to automatically personalize the intensity and type of patient support. The specific aims of the study are to (1) demonstrate that AI-CBT has pain-related outcomes equivalent to standard telephone CBT, (2) document that AI-CBT achieves these outcomes with more efficient use of clinician resources, and (3) demonstrate the intervention’s impact on proximal outcomes associated with treatment response, including program engagement, pain management skill acquisition, and patients’ likelihood of dropout. Methods: In total, 320 patients with chronic low back pain will be recruited from 2 VA healthcare systems and randomized to a standard 10 sessions of telephone CBT versus AI-CBT. All patients will begin with weekly hour-long telephone counseling, but for patients in the AI-CBT group, those who demonstrate a significant treatment response will be stepped down through less resource-intensive alternatives including: (1) 15-minute contacts with a therapist, and (2) CBT clinician feedback provided via interactive voice response calls (IVR). The AI engine will learn what works best in terms of patients’ personally tailored treatment plans based on daily feedback via IVR about their pedometer-measured step counts, CBT skill practice, and physical functioning. Outcomes will be measured at 3 and 6 months post recruitment and will include pain-related interference, treatment satisfaction, and treatment dropout. Our primary hypothesis is that AI-CBT will result in pain-related functional outcomes that are at least as good as the standard approach, and that by scaling back the intensity of contact that is not associated with additional gains in pain control, the AI-CBT approach will be significantly less costly in terms of therapy time. Results: The trial is currently in the start-up phase. Patient enrollment will begin in the fall of 2016 and results of the trial will be available in the winter of 2019. Conclusions: This study will evaluate an intervention that increases patients’ access to effective CBT pain management services while allowing health systems to maximize program expansion given constrained resources.

Comprehensive medication reviews (CMRs) consist of in-depth reviews of patients' medications to identify effectiveness or safety problems and often generate cost savings for individuals. Despite their advantages, CMRs are not widely obtained. Previous studies found that older age, female sex, and experience of side effects were associated with obtaining a medication review.To quantify the association between attitudinal and clinical factors with intention and predict future behavior to obtain a CMR among Medicare Part D beneficiaries.A sample of Medicare Part D beneficiaries from 1 health care plan (n = 660) completed a 14-item survey over the telephone assessing factors that were hypothesized to affect their intention and behavior to obtain a CMR. The survey collected medication use history and health care information with the medication user self-evaluation tool, health status, adherence, intention to obtain a CMR, and demographic characteristics. Subjects subsequently were informed that they could obtain a CMR from their pharmacies. Claims data were obtained that indicated which subjects received a CMR. Two dependent variables were predicted: intention to schedule a CMR using a multivariate linear regression model and receipt of a CMR using a logistic regression and including intention as a predictor variable.The mean age of participants was 76.6 (SD = 7.61) years; 71% were female; and participants took an average of 5.2 (SD = 3.18) medications. The intention to have a CMR was 2.85 (SD = 1.41) on a 5-point scale, and 5.6% of the participants actually had a CMR. Worrying about medications doing more harm than good, number of pharmacies where participants obtained their medications from, number of medications, and number of medical conditions predicted intention to obtain a CMR. Patients who perceived their health status to be poorer compared with others their age were more likely to have a CMR. Intention to obtain a CMR was not associated with receipt of a CMR.Stakeholders should target patients who perceive their health to be poor for a CMR, hence expanding the scope of CMRs and increasing the number of older adults benefiting from this service.This study was funded by a grant from the Agency for Healthcare Research and Quality (1R18HS018353). Frank is an employee of Outcomes MTM. Pendergast has received grants from the NIH, NIA, and PICORI. Farris has received grants from NIH and speaker fees from Chulalongkorn University, Bangkok, Thailand, and the American College of Clinical Pharmacy. All other authors declare that they have no conflicts of interest. Study concept was developed by Farris, Pendergast, Chrischilles, and Doucette. Pendergast, Frank, Farris, and Aneese collected the data, with assistance from Chrischilles and Doucette. Data interpretation was performed by Farris, Marshall, Salgado, and Aneese, with assistance from the other authors. The manuscript was written by Farris, Salgado, and Aneese, with assistance from the other authors, and revised by Salgado and Marshall, assisted by the other authors.

To assess the impact of a patient engagement intervention utilizing the Medication User Self-Evaluation (MUSE) tool on the completion percentage of comprehensive medication reviews (CMRs) among Medicare Part D beneficiaries.A case-control study.Beneficiaries from 2 Medicare Part D plans were randomly assigned to 3 study arms (1 control arm plus 2 intervention arms for 2011 and 2012, respectively). Each beneficiary who participated in the MUSE intervention met 3 inclusion criteria and was matched with a single control group beneficiary based on: gender; age (within 5-year interval); plan type (ie, Medicare Prescription Drug Plan, Medicare Advantage Prescription Drug Plan); number of unique prescriptions; pharmacy medication therapy management (MTM) training status; and time period (2011, 2012). The outcome of interest was whether or not the beneficiary received a CMR in the 6 months following the index date. Generalized estimating equation (GEE) models were used to compare CMR percentages over time and between MUSE intervention groups. This study used MTM service claims data.The final sample of 1015 beneficiaries received MUSE intervention, of which 1007 were successfully matched to a control beneficiary. The estimated odds of having a CMR among those who received the MUSE intervention were 2 times that of their counterparts (P = .0048) across both study years.Given the strong evidence found for a positive association between participation in a CMR and the MUSE intervention, Part D plans could use the MUSE to engage targeted beneficiaries in using pharmacist-provided MTM services.