Patient symptoms, self-management, and unscheduled healthcare use during the first 6 months of targeted oral anticancer agent therapy: protocol for a mixed-methods US study.

INTRODUCTION: Targeted oral anticancer agents (OAAs) are increasingly used to treat cancer, including haematological malignancies and ovarian cancer, but they can cause serious symptomatic side effects such as arrhythmias, hypertension, and hyperglycaemia. Unaddressed OAA symptoms or inadequately managed symptoms may also lead to unnecessary and unscheduled healthcare use that decreases patient quality of life and financially burdens both patients and the healthcare system. Limited information is available about patient symptoms, self-management behaviours, and use of healthcare services over time while taking targeted OAAs, but is needed to ensure successful OAA therapy. The primary objective is to understand patient experiences and behaviours on initiating targeted OAA, and elicit cancer care clinicians' (ie, physicians, advanced practice practitioners, nurses, and pharmacists) perspectives on supporting patients during therapy. Study results will inform comprehensive and realistic interventions that minimise disruptions to therapy while maximising quality of life. METHODS AND ANALYSIS: We will conduct a remote single-arm, convergent-parallel mixed-methods cohort study within a large academic medical centre. A minimum of 60 patients will be enrolled. Patients will complete several validated patient-reported outcome measures at six timepoints over 6 months. Mixed-effects logistic regression will be used to predict the primary binary outcome of unscheduled healthcare use by patient self-efficacy for symptom self-management. Semistructured interviews will be conducted with patients and clinicians and thematically analysed. Triangulated quantitative and qualitative results will be reported using cross-case comparison joint display. ETHICS AND DISSEMINATION: This study protocol is approved by the Institutional Review Board of University of Michigan Medical School (IRBMED). Study results will be published in peer-reviewed journals, presented at conferences, and disseminated to study participants.

Photo elicitation, an approach to better understanding the patient experience with OAAs: pilot study and future implications.

PURPOSE: Oral anti-cancer agents (OAAs) represent a new frontier in cancer treatment, but we do not know how well patients incorporate the strategies that they are taught for managing the side effects of OAAs into their daily lives. The purpose of this study was to understand how OAA side effects influenced patients' lives and what strategies patients used to manage them. METHODS: The study used an interpretive descriptive design utilizing photo elicitation interviews (PEI). Two pharmacists employed at the study ambulatory oncology clinic assisted with recruitment. Participants took photos and subsequent interviews focused on talking to participants about each photo, eliciting participant perspectives describing side effects of OAAs and management strategies. A directed content analysis approach was used to analyze the transcribed interviews. RESULTS: A total of nine participants were included in the study. Three themes and associated sub-themes emerged: making changes to nutritional habits due to OAA side effects (hydration and food), strategies to alleviate OAA side effects (medication and non-medication related), and methods of coping with OAA effects (intra- and interpersonal). Changing nutritional habits was an important strategy to manage OAA side effects. Medication-related strategies to alleviate OAA side effects could be nuanced and, additionally, there was wide variability in coping methods used. CONCLUSION: Patient education on OAAs and side effects is not always tailored to each unique patient and their circumstances. This study uncovered how participants devised their own distinct strategies to prevent or manage OAA side effects in an effort to help improve patients' experiences when taking OAAs.

Oncologists' responsibility, comfort, and knowledge managing hyperglycemia in patients with cancer undergoing chemotherapy: a cross sectional study.

PURPOSE: To assess oncologists' responsibility, comfort, and knowledge managing hyperglycemia in patients undergoing chemotherapy. METHODS: In this cross-sectional study, a questionnaire collected oncologists' perceptions about professionals responsible for managing hyperglycemia during chemotherapy; comfort (score range 12-120); and knowledge (score range 0-16). Descriptive statistics were calculated including Student t-tests and one-way ANOVA for mean score differences. Multivariable linear regression identified predictors of comfort and knowledge scores. RESULTS: Respondents (N = 229) were 67.7% men, 91.3% White and mean age 52.1 years. Oncologists perceived endocrinologists/diabetologists and primary care physicians as those responsible for managing hyperglycemia during chemotherapy, and most frequently referred to these clinicians. Reasons for referral included lack of time to manage hyperglycemia (62.4%), belief that patients would benefit from referral to an alternative provider clinician (54.1%), and not perceiving hyperglycemia management in their scope of practice (52.4%). The top-3 barriers to patient referral were long wait times for primary care (69.9%) and endocrinology (68.1%) visits, and patient's provider outside of the oncologist's institution (52.8%). The top-3 barriers to treating hyperglycemia were lack of knowledge about when to start insulin, how to adjust insulin, and what insulin type works best. Women (ß = 1.67, 95% CI: 0.16, 3.18) and oncologists in suburban areas (ß = 6.98, 95% CI: 2.53, 11.44) had higher comfort scores than their respective counterparts; oncologists working in practices with > 10 oncologists had lower comfort scores (ß = -2.75, 95% CI: -4.96, -0.53) than those in practices with ≤ 10. No significant predictors were identified for knowledge. CONCLUSION: Oncologists expected endocrinology or primary care clinicians to manage hyperglycemia during chemotherapy, but long wait times were among the top barriers cited when referring patients. New models that provide prompt and coordinated care are needed.

Predictors of Receipt of Comprehensive Medication Reviews in Older Adults.

BACKGROUND: Polypharmacy is highly prevalent among older adults. This study's purpose was to provide nationally representative estimates of self-reported comprehensive medication review (CMR) receipt among older adults and describe factors associated with their receipt, as CMRs are available through the Medicare Part D program. METHODS: This cross-sectional study used data from the National Poll on Healthy Aging (NPHA), a nationally representative online survey of community-dwelling adults aged 50-80, administered in December 2019. Participants included older adults aged 65-80 with any health insurance (n = 960). Outcomes were self-reported CMR receipt, awareness of CMR insurance coverage, and interest in a future CMR with a pharmacist. Sociodemographic and health-related variables were included. Descriptive statistics and multivariable logistic regression with NPHA population sampling weights were used. RESULTS: Among older adults on 2 or more prescription medications, only 20.8% had received a CMR while 34.3% were interested in a future CMR. Among individuals who had not received a CMR, most (83.4%) were unaware their insurance might cover a CMR. Factors associated with higher odds of receiving a CMR included taking 5 or more prescription medications (adjusted odds ratio [AOR] = 2.6, 95% CI: 1.59-4.38) and reporting food insecurity (AOR = 2.9, 95% CI: 1.07-7.93). Having fair or poor self-reported physical health was associated with lower odds of receiving a CMR (AOR = 0.49, 95% CI: 0.25-0.97). CONCLUSIONS: Most older adults on 2 or more prescription medications with health insurance had not received a CMR and many were interested in one. Targeted strategies to increase older adults' awareness and receipt of CMRs are warranted.

Cancer Drug Safety Training: Comparing Distance and In-Person Simulations for Interprofessional Education.

The Multi-Professional Oncology Safety and Simulation Training (MOSST) program, supported by the National Cancer Institute was launched in Fall 2018. The original workshop was conducted in person. As the COVID pandemic hit the program was transitioned to an online/distance simulation program using best practices in healthcare simulation design and implementation. The full day workshop was moved to an online platform using Zoom and the in-person simulations were re-developed as video branching case simulations. Learner outcomes that were identical in each modality were evaluated using the evaluation metrics from the original workshop. The use of a distance simulation modality to deliver the MOSST workshop resulted in a high-quality educational experience for the learners and the educational outcomes were comparable to the in-person version. Distance simulation using virtual unfolding case studies and didactic content showed comparable subjective and objective outcomes from participating learners. This work adds to the developing body of research on distance simulation.

Feasibility of a comprehensive medication review to improve medication use for patients with cancer and comorbid conditions.

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.

Implementation of a model integrating primary and oncology pharmacists' care for patients taking oral anticancer agents (OAA).

Improvements in chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM) treatment options have increased the 5-year survival rates for patients with these hematologic malignancies. In addition to cancer management, these patients may need help to manage multiple chronic conditions (MCC). The overall objective of this study is to examine the impact and implementation of a model that coordinates care between oncology and primary care pharmacists for people taking an oral anti-cancer agent (OAAs) and medications for comorbid chronic conditions. This is a multi-center, prospective, single-arm pilot study that will recruit up to 40 patients from Michigan Medicine and Vanderbilt University Medical Center (VUMC). Eligible participants will be 18 years of age or older, prescribed an OAA, have a diagnosis of either CML, CLL or MM, and be diagnosed with and taking medication for at least two specified chronic conditions. The Pharmacists Coordinated Care Oncology Model (PCOM) is a two-month intervention that builds upon current pharmacist clinical responsibilities. Generally, participants will complete a patient-reported outcome measure at 2 and 6 weeks post-OAA initiation that is sent to their oncology pharmacist, and they will also receive a comprehensive medication review at week 4 from a primary care pharmacist for their chronic medications. The pharmacists will communicate about the results via electronic medical record (EMR) and intervene if necessary. The primary endpoints are (1) dose-adjusted OAA proportion of days covered (PDC), and (2) PDC for chronic condition medications. PDCs will be determined via prescription records. The association of OAA and chronic medication PDCs will be quantified via correlation and chi-squared tests. The association between symptom experience and OAA adherence will be examined via correlation analyses. For implementation, characteristics of patient participants, feasibility, acceptability, adoption, fidelity, and trialability will be described. Data will be collected via EMR and pharmacist and patient interviews. Median/IQR for acceptability, adoption and fidelity will be reported, and patient interviews will be analyzed using a grounded theory approach and pharmacist interviews will be analyzed using thematic analyses.

The Effects of the ManageHF4Life Mobile App on Patients With Chronic Heart Failure: Randomized Controlled Trial.

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.

Evaluation of an Interprofessional Training Program to Improve Cancer Drug Therapy Safety.

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.

Primary healthcare policy and vision for community pharmacy and pharmacists in the United States.

The United States (US) has a complex healthcare system with a mix of public, private, nonprofit, and for-profit insurers, healthcare institutions and organizations, and providers. Unlike other developed countries, there is not a single payer healthcare system or a national pharmaceutical benefits scheme/plan. Despite spending over USD 10,000 per capita in healthcare, the US is among the worst performers compared to other developed countries in outcomes including life expectancy at birth, infant mortality, safety during childbirth, and unmanaged chronic conditions (e.g., asthma, diabetes). Primary care is delivered by physicians and advanced practice providers (i.e., nurse practitioners and physician assistants) in a variety of settings including large health systems, federally qualified health centers or free clinics that provide care to the underserved, or specific facilities for veterans or American Indian and Alaska native peoples. Since 2010, primary care delivery has shifted toward providing patient-centered, coordinated, comprehensive care focused on providing proactive, rather than reactive, population health management, and on the quality, versus volume, of care. Community pharmacy comprises a mix of independently owned, chain, supermarket and mass merchant pharmacies. Community pharmacies provide services such as immunizations, medication therapy management, medication packaging, medication synchronization, point-of-care testing and, in specific states where legislation has been passed, hormonal contraception, opioid reversal agents, and smoking cessation services. There has been criticism regarding the lack of standard terminology for services such as medication synchronization and medication therapy management, their components and how they should be provided, which hampers comparability across studies. One of the main challenges for pharmacists in the US is the lack of provider status at the federal level. This means that pharmacists are not allowed to use existing fee-for-service health insurance billing codes to receive reimbursement for non-dispensing services. In addition, despite there being regulatory infrastructure in multiple states, the extent of service implementation is either low or unknown. Research found that pharmacists face numerous barriers when providing some of these services. State fragmentation and the lack of a single pharmacy organization and vision for the profession are additional challenges.

Patient factors associated with discrepancies between patient-reported and clinician-documented peripheral neuropathy in women with breast cancer receiving paclitaxel: A pilot study.

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.

Reporting of paclitaxel-induced peripheral neuropathy symptoms to clinicians among women with breast cancer: a qualitative study.

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 relationship 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.

Side Effects, Self-Management Activities, and Adherence to Oral Anticancer Agents.

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<0.05. 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.

Impact of a Statewide Oral Oncolytic Initiative on Five Participating Practices.

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.

Identifying socio-demographic and clinical characteristics associated with medication beliefs about aromatase inhibitors among postmenopausal women with breast cancer.

PURPOSE: Non-adherence/persistence to adjuvant endocrine therapy can negatively impact survival. Beliefs about medicines are known to affect adherence. This study aims to identify socio-demographic and clinical characteristics associated with medication beliefs among women taking aromatase inhibitors (AIs). METHODS: Women completed an online survey on beliefs about AI therapy [Beliefs about Medicines Questionnaire (BMQ)], beliefs about breast cancer [Assessment of Survivor Concerns scale (ASC)], and depression [Personal Health Questionnaire depression scale (PHQ-8)]. Socio-demographic and clinical characteristics were collected. Bivariate analyses and linear regression models were performed to investigate relationships between variables. RESULTS: A total of 224 women reported currently taking AI therapy and were included in the analysis. Significantly higher concern beliefs were found among women who had at least mild depression, experienced side effects from AIs, and previously stopped therapy with another AI. Significant correlations were found between concern and necessity beliefs and cancer and health worry. Women age 70 and older displayed less fear of cancer recurrence and health worry, and a trend towards lower necessity and concern beliefs. No differences were found for other variables. In the regression model, greater necessity beliefs were found with increases in the number of current prescription medications (B = 1.06, 95% CI 0.31-1.81, p = 0.006) and shorter duration of current AI therapy (B = -0.65, 95% CI -1.23 to -0.07, p = 0.029), whereas greater concern beliefs were associated with higher depression scores (B = 1.19, 95% CI 0.35-2.03, p = 0.006). CONCLUSIONS: Medication necessity and concern beliefs were associated with a definable subset of patients who may be at higher risk for non-persistence.

The relationship between patient activation, confidence to self-manage side effects, and adherence to oral oncolytics: a pilot study with Michigan oncology practices.

PURPOSE: The Michigan Oncology Quality Consortium (MOQC) is a continuous quality improvement collaborative seeking to improve oncology care in Michigan, including for patients taking oral chemotherapy. The aim of this study was to assess the relationship between patient activation, confidence to self-manage side effects, and adherence to oral oncolytics to inform future oncology care. METHODS: A multicenter cross-sectional observational study was conducted using an online survey to examine patient activation (patient activation measure, PAM), health literacy, symptom burden (Edmonton Symptom Assessment System, ESAS), confidence to self-manage side effects (fatigue, nausea, and diarrhea), and adherence to oral oncolytics. Inclusion criteria were patients taking an oral oncolytic for at least 1 month. Bivariate analyses and logistic regression were performed to evaluate relationships between the variables. RESULTS: A total of 125 respondents, mean (SD) age 66.2 (13.6), 57.7% female, and 95.1% Caucasian completed the survey. The mean (SD) PAM score was 65.0 (18.0). Confidence to manage fatigue, nausea, and diarrhea was associated with higher activation, and confidence to self-manage fatigue and diarrhea were associated with higher health literacy. About 30% of participants reported some level of non-adherence to oral oncolytics, and those who experienced side effects (Fisher's exact test p = 0.033) and with shorter length of therapy (t test p = 0.027) were significantly more likely to be non-adherent. CONCLUSIONS: These findings show that there is room for improvement across practices involved with MOQC with regard to supporting patients taking oral oncolytics. Patients will need to improve their activation levels, and oncology clinics will need to create new workflows in order to enhance self-care management ability for patients taking oral oncolytics.

Patient-centered medical home: developing, expanding, and sustaining a role for pharmacists.

PURPOSE: The development of a patient-centered medical home (PCMH) health care model and the role of pharmacists in PCMHs at the University of Michigan are described. SUMMARY: In 2009, Blue Cross Blue Shield of Michigan (BCBSM) provided financial incentives to physician groups to implement PCMH principles. A partnership was formed among the department of pharmacy, college of pharmacy, and faculty group practice at the University of Michigan Health System (UMHS) to integrate clinical pharmacists into the PCMH model at eight general medicine practices. The rationale was that PCMH pharmacists could assist in managing chronic conditions by substituting or augmenting physician care, help achieve quality indicators, and increase revenue by billing for their services. At the University of Michigan, PCMH pharmacists currently provide direct patient care services at eight general medicine health centers for patients with diabetes, hypertension, hyperlipidemia, and polypharmacy, which are billable using T codes, which are payable to UMHS by most BCBSM plans. In the first year, the number of PCMH pharmacist half-day clinics varied from one to six per health center, and the mean number of patients per half-day clinic ranged from 2.2 to 6. Pharmacists in four PCMHs made more medication changes per visit than the other four, particularly for patients with diabetes. CONCLUSION: At the University of Michigan, PCMH pharmacists currently provide direct patient care services at eight general medicine health centers for patients with diabetes, hypertension, hyperlipidemia, and polypharmacy via referral from physicians.

Effect of a pharmacist managed smoking cessation clinic on quit rates.

OBJECTIVE: The purpose of this study was to quantify quit rates, determine factors predicting success, and analyze patients' perceptions at 3 months after participation in the pharmacist-managed Smoking Cessation Group Clinic. METHODS: This was a prospective, single group study that was conducted in patients that had participated in the Smoking Cessation Group Clinic at the University of Iowa Hospitals and Clinics. Clinic participants received structured group counseling covering various topics associated with cessation. Varenicline, bupropion and nicotine replacement therapy were used as smoking cessation aids and selection was based on patient preference and absence of contraindications. The primary outcome of this trial was smoking status at 3 months. The patients were contacted by telephone at 3, and 6 months after the start of the clinic and asked about current smoking status. At 3 months, patients were asked to rate on a Likert scale of 1 to 5 (1=not helpful; 5=very helpful) their perceptions of individual aspects of the clinic and on a scale of 1 to 10 (1=not helpful; 10=very helpful) how they perceived their cessation aid. RESULTS: From February 2007 to January 2008, 21 patients enrolled in the intent-to-treat follow up study. Analysis of data was completed in August 2008. At 3 and 6 months, 47.6% and 52.4%, of patients reported being smoke-free, respectively. At 3 months, factors consistent with success included having more previous quit attempts and type of cessation aid used. These endpoints continued to be significant at 6 months, in addition to attending more clinic sessions, and type of insurance (favoring private insurance). Patients who quit smoking rated their cessation aid as more helpful than those who did not quit smoking (8.56; SD=0.88 verses 6.71; SD=2.81, respectively; p=0.14). The aspect of the clinic most helpful to patients was group interaction (4.53; SD=0.77). CONCLUSION: This study demonstrates that pharmacists can play a vital role with smoking cessation in a group setting. Group setting patient counseling can be an effective tool for pharmacists to reach more people within the same time frame as individual counseling.

Predicting tobacco sales in community pharmacies using population demographics and pharmacy type.

OBJECTIVE: To determine whether the population demographics of the location of pharmacies were associated with tobacco sales in pharmacies, when controlling for pharmacy type. DESIGN: Retrospective analysis. SETTING: Iowa. PARTICIPANTS: All retailers in Iowa that obtained tobacco licenses and all pharmacies registered with the Iowa Board of Pharmacy in 2003. MAIN OUTCOME MEASURE AND INTERVENTIONS: Percentage of pharmacies selling tobacco (examined by pharmacy type using chi-square analysis); median income and distribution of race/ethnicity in the county for pharmacies that did or did not sell tobacco (t tests); predictors of whether a pharmacy sold tobacco (logistic regression using the independent variables county-level demographic variables and pharmacy characteristics). RESULTS: County gender composition, race/ethnicity make-up, and income levels were different for tobacco-selling and -nonselling pharmacies. Logistic regression showed that whether a pharmacy sold tobacco was strongly dependent on the type of pharmacy; compared with independent pharmacies (of which only 5% sold tobacco products), chain pharmacies were 34 times more likely to sell tobacco products, mass merchandiser outlets were 47 times more likely to stock these goods, and grocery stores were 378 times more likely to do so. Pharmacies selling tobacco were more likely to be located in counties with significantly higher numbers of multiracial groups. CONCLUSION: The best predictor of whether an Iowa pharmacy sells tobacco products is type of pharmacy. In multivariable analyses, population demographics of the county in which pharmacies were located were generally not predictive of whether a pharmacy sold tobacco.