Elizabeth Kvale

Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.

IMPORTANCE For patients with limited prognosis, some medication risks may outweigh the benefits, particularly when benefits take years to accrue; statins are one example. Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy. OBJECTIVE To evaluate the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting. DESIGN, SETTING, AND PARTICIPANTS This was a multicenter, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease, recent deterioration in functional status, and no recent active cardiovascular disease. Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year. The study was conducted from June 3, 2011, to May 2, 2013. All analyses were performed using an intent-to-treat approach. INTERVENTIONS Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins. MAIN OUTCOMES AND MEASURES Outcomes included death within 60 days (primary outcome), survival, cardiovascular events, performance status, quality of life (QOL), symptoms, number of nonstatin medications, and cost savings. RESULTS A total of 381 patients were enrolled; 189 of these were randomized to discontinue statins, and 192 were randomized to continue therapy. Mean (SD) age was 74.1 (11.6) years, 22.0% of the participants were cognitively impaired, and 48.8% had cancer. The proportion of participants in the discontinuation vs continuation groups who died within 60 days was not significantly different (23.8% vs 20.3%; 90% CI, -3.5% to 10.5%; P=.36) and did not meet the noninferiority end point. Total QOL was better for the group discontinuing statin therapy (mean McGill QOL score, 7.11 vs 6.85; P=.04). Few participants experienced cardiovascular events (13 in the discontinuation group vs 11 in the continuation group). Mean cost savings were

Practical clinical interventions for diet, physical activity, and weight control in cancer survivors

3.37 per day and

Distress and quality of life in primary high-grade brain tumor patients

716 per patient. CONCLUSIONS AND RELEVANCE This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs. Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01415934.

Multimorbidity: an issue of growing importance for oncologists.

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The Patient Care Connect Program: Transforming Health Care Through Lay Navigation

Goals of workWe report on the routine use of the NCCN Distress Thermometer and the Functional Assessment of Cancer Therapy—Brain (FACT-Br) to assess patient distress and quality of life in GBM patients. The purpose of this study was to examine the relationship between patient quality of life and distress.Materials and methodsData from 50 GBM patients presenting to a neuro-oncology clinic were evaluated. Descriptive statistics and correlations between the distress score and the FACT-Br subscale scores were generated.Main resultsThe mean distress score was 2.15 (std 2.66), and 28.9% of brain tumor patients identified a distress score of 4 or above. The mean FACT-Br total was 127.34 (std 21.29), with patients scoring lowest in the EWB (18.95 std 4.4) and FWB (15.06 std 6.80) subscales. No differences between demographic groups were identified with regard to distress or quality of life. Statistically significant correlations were identified between the distress score and the SWB (R = −0.46, P = 0.001) and EWB (R = −0.56, P = 0.001) subscales of the FACT-Br. Fifty percent of participants who did not complete the FACT-Br reported clinically significant distress, but this did not differ significantly from participants who completed it.ConclusionsAssessment of distress in brain tumor patients provides clinically relevant information and suggests interventions that may support quality of life. Further research is needed to explore the relationship between distress and quality of life. Current approaches to measuring quality of life in brain tumor patients may systematically undersample patients with advanced illness or significant psychosocial distress.

Resource Use and Medicare Costs During Lay Navigation for Geriatric Patients With Cancer

As our population ages, more are afflicted with chronic conditions. Likewise, as more patients survive the diagnosis of cancer, they are likely to experience the sequelae of cancer treatment in the context of other coexisting medical conditions. Oncologists can expect that more than half of the patients they see who are older than 65 years will have at least one other meaningful chronic condition that may affect their treatment regimen. Multimorbidity can increase both treatment and illness burden and influence the benefit and burden of cancer treatment. Recognition of the impact of multiple co-occurring conditions on a patients cancer care plan and development of strategies to address the challenges associated with multimorbidity will enable oncologists to provide higher quality, patient-centered care. Increased efforts should be focused on educating clinical providers to practice the collaborative, team-based care required by these patients. Finally, research is desperately needed to guide oncologists and other providers in the unique management issues presented by patients with multimorbidity.

Cognitive Speed of Processing and Functional Declines in Older Cancer Survivors: An Analysis of Data from the ACTIVE Trial

The Patient Care Connect Program (PCCP) is a lay patient navigation program, implemented by the University of Alabama at Birmingham Health System Cancer Community Network. The PCCPs goal is to provide better health and health care, as well as to lower overall expenditures. The program focuses on enhancing the health of patients, with emphasis on patient empowerment and promoting proactive participation in health care. Navigator training emphasizes palliative care principles and includes development of skills to facilitate advance care planning conversations. Lay navigators are integrated into the health care team, with the support of a nurse supervisor, physician medical director, and administrative champion. The intervention focuses on patients with high needs to reach those with the greatest potential for benefit from supportive services. Navigator activities are guided by frequent distress assessments, which help to identify patient concerns across multiple domains, triage patients to appropriate resources, and ultimately overcome barriers to health care. In this article, we describe the PCCPs development, infrastructure, selection and training of lay navigators, and program operations.

Systematic Review of Palliative Care in the Rural Setting

Importance Lay navigators in the Patient Care Connect Program support patients with cancer from diagnosis through survivorship to end of life. They empower patients to engage in their health care and navigate them through the increasingly complex health care system. Navigation programs can improve access to care, enhance coordination of care, and overcome barriers to timely, high-quality health care. However, few data exist regarding the financial implications of implementing a lay navigation program. Objective To examine the influence of lay navigation on health care spending and resource use among geriatric patients with cancer within The University of Alabama at Birmingham Health System Cancer Community Network. Design, Setting, and Participants This observational study from January 1, 2012, through December 31, 2015, used propensity score–matched regression analysis to compare quarterly changes in the mean total Medicare costs and resource use between navigated patients and nonnavigated, matched comparison patients. The setting was The University of Alabama at Birmingham Health System Cancer Community Network, which includes 2 academic and 10 community cancer centers across Alabama, Georgia, Florida, Mississippi, and Tennessee. Participants were Medicare beneficiaries with cancer who received care at participating institutions from 2012 through 2015. Exposures The primary exposure was contact with a patient navigator. Navigated patients were matched to nonnavigated patients on age, race, sex, cancer acuity (high vs low), comorbidity score, and preenrollment characteristics (costs, emergency department visits, hospitalizations, intensive care unit admissions, and chemotherapy in the preenrollment quarter). Main Outcomes and Measures Total costs to Medicare, components of cost, and resource use (emergency department visits, hospitalizations, and intensive care unit admissions). Results In total, 12 428 patients (mean (SD) age at cancer diagnosis, 75 (7) years; 52.0% female) were propensity score matched, including 6214 patients in the navigated group and 6214 patients in the matched nonnavigated comparison group. Compared with the matched comparison group, the mean total costs declined by

An introduction to tree-structured modeling with application to quality of life data

781.29 more per quarter per navigated patient (&bgr; = −781.29, SE = 45.77, P < .001), for an estimated

Palliative care, version 2.2017: Featured updates to the NCCN guidelines

19 million decline per year across the network. Inpatient and outpatient costs had the largest between-group quarterly declines, at