A randomized study to improve care for young women with breast cancer at community and academic medical oncology practices in the United States: The Young and Strong study.

BACKGROUND: The authors conducted a cluster randomized study to determine the effect of an exportable educational intervention for young women with breast cancer (YWI) on improving care. METHODS: Sites were randomized 1:1 to the YWI or a contact time control physical activity intervention (PAI) stratified by academic or community site. Up to 15 women aged ≤45 years with newly diagnosed breast cancer were enrolled at each of 14 academic sites and 10 were enrolled at each of 40 community sites. The primary endpoint, attention to fertility, was ascertained by medical record review. Statistical inferences concerning the effect of the intervention used general estimating equations for clustered data. RESULTS: A total of 467 patients across 54 sites were enrolled between July 2012 and December 2013. The median age of the patients at the time of diagnosis was 40 years (range, 22-45 years). Attention to fertility by 3 months was observed in 55% of patients in the YWI and 58% of patients in the PAI (P = .88). Rates were found to be strongly correlated with age (P < .0001), and were highest in patients aged <30 years. Attention to genetics was similar (80% in the YWI and 81% in the PAI), whereas attention to emotional health was higher in patients in the YWI (87% vs 76%; estimated odds ratio, 2.63 [95% confidence interval, 1.20-5.76; P = .016]). Patients rated both interventions as valuable in providing education (64% in the YWI and 63% in the PAI). CONCLUSIONS: The current study failed to demonstrate differences in attention to fertility with an intervention to improve care for women with breast cancer, although attention to fertility was found to be higher than expected in both groups and emotional health was improved in the YWI group. Greater attention to young women with breast cancer in general may promote more comprehensive care for this population.

A review of quality of care evaluation for the palliation of dyspnea.

Assessment and management of dyspnea has emerged as a priority topic for quality evaluation and improvement. Evaluating dyspnea quality of care requires valid, reliable, and responsive measures of the care provided to patients across settings and diseases. As part of an Agency for Healthcare Research and Quality Symposium, we reviewed quality of care measures for dyspnea by compiling quality measures identified in systematic searches and reviews. Systematic reviews identified only three existing quality measurement sets that included quality measures for dyspnea care. The existing dyspnea quality measures reported by retrospective evaluations of care assess only four aspects: dyspnea assessment within 48 hours of hospital admission, use of objective scales to rate dyspnea severity, identification of management plans, and evidence of dyspnea reduction. To begin to improve care, clinicians need to assess and regularly document patient's experiences of dyspnea. There is no consensus on how dyspnea should be characterized for quality measurement, and although over 40 tools exist to assess dyspnea, no rating scale or instrument is ideal for palliative care. The panel recommended that dyspnea assessment should include a measure of intensity and some inquiry into the associated bother or distress experienced by the patient. A simple question into the presence or absence of dyspnea would be unlikely to help guide therapy, as complete relief of dyspnea in advanced disease would not be anticipated. Additional knowledge gaps include standards for clinical dyspnea care, assessment in the cognitively impaired, and evaluation of effectiveness of dyspnea care for patients with advanced disease.

Impact of a G-CSF Policy to Reduce Low-Value Care on Guideline Adherence and Mortality.

PURPOSE: Practice guidelines recommend the prophylactic use of granulocyte colony-stimulating factors (G-CSFs) in patients with high risk of febrile neutropenia, but evidence suggests that G-CSFs are frequently overused. The objectives of this study were (1) to determine the prevalence and prescribing patterns of G-CSF and (2) to evaluate the impact of a program initiative on G-CSF prescribing patterns, adherence to guidelines, and mortality. METHODS: In this retrospective cohort study, data were used from the electronic health records of patients with metastatic colorectal cancer who received care at a multicenter oncology practice network during two time periods: July 01, 2013, to December 31, 2014, and July 01, 2017, to December 31, 2017. Beginning 2016, a site-wide program initiative that involved educational materials, appropriate nonuse recommendations, and prior authorization was introduced in the oncology practice network with an aim of reducing G-CSF overutilization. Descriptive statistics, t tests, and chi-squared tests were employed to analyze program impact. RESULTS: There were 3,426 chemotherapy regimens corresponding to 2,968 patients. There were a total of 387 (11.3%) G-CSF-treated patients and 3,095 G-CSF administrations during the study period. G-CSF use was significantly lower in the postperiod, compared with the preperiod (P < .0001). Adherence to guidelines was significantly higher in the postperiod, compared with the preperiod (P < .0001). Mortality rates did not significantly differ between the two time periods. CONCLUSION: This study demonstrates that policy initiatives have the potential to positively affect G-CSF prescription patterns and promote guideline adherence. These findings could help prescribers adopt a cost-effective approach in patients with metastatic colorectal cancer, leading to enhanced clinical practice and value-based care.

Secret Sauce-How Diverse Practices Succeed in Centers for Medicare & Medicaid Services Oncology Care Model.

PURPOSE: CMS' Oncology Care Model (OCM) is an episode-based alternative payment model designed to incent high-value care through the use of monthly payments for enhanced services and performance-based payments on the basis of decreases in spending compared with risk-adjusted historical benchmarks. Transitioning from a fee-for-service model to a value-based, alternative payment model in oncology can be difficult; some practices will perform better than others. We present detailed experiences of four successful OCM practices, each operating under diverse business models and in different geographic areas. METHODS: Practices that achieved success in OCM, on the basis of financial metrics, describe pathways to success. The practices represent distinct business models: a medium-sized community oncology practice, a large statewide community oncology practice, a hospital-affiliated practice, and a large academic medical center. RESULTS: Practices describe effective changes in practice culture such as new administrative flexibilities, physician champions, improved communication, changes in physician compensation, and increased physician-level transparency. New or improved clinical services include acute care clinics, care coordination, phone triage, end-of-life care programs, and adoption of treatment pathways that identify high-value drug use, including better use of supportive care drugs. CONCLUSION: There is no one thing that will ensure success in OCM. Success requires whole practice transformation, encompassing both administrative and clinical changes. Communication between administrative and clinical teams is vital, along with improved data sharing and transparency. Clinical support services must expand to manage problems and symptoms in a timely way to prevent costly emergency department visits and hospitalizations, while constant attention must be paid to making high-value therapeutic choices in both oncolytic and supportive drug categories.

Rethinking clinical oncology drug research in an era of value-based cancer care: A role for chemotherapy pathways.

The United States spends nearly 1/5th of its GDP on healthcare. Yet, to achieve value-based care, the Economist describes the US healthcare system as handicapped by multiple, disparate silos that prevent the organization and sharing of data. This paper explores the current state of clinical oncology drug research and its relationship to value-based cancer care. Clinical Chemotherapy Pathways are proposed as a unifying structure to bring together disparate sources of data to increase value.

Hospice or Hospital: The Costs of Dying of Cancer in the Oncology Care Model.

Background: End-of-life management is a difficult aspect of cancer care. With the oncology care model (OCM), we have data to assess both clinical outcomes and total cost of care (TCOC). Objective: To measure and characterize the TCOC for those who received less than three days of hospice care (HC) at the end of life compared with those who received three days or more. Design: Assess data on costs and site and date of death from Medicare claims on patients identified in the OCM who received chemotherapy in the six months before death. Standard statistical methods were used to characterize both populations. Setting/Subjects: Subjects were Medicare patients with cancer who died while managed by U.S. oncology practices in the OCM. Measurements were TCOC in 30-day intervals for the last months of life, cost by site of care at the end of life, and demographic characteristics of the population and association with HC. Results: There were 7329 deaths. Dying in the hospital was twice the cost of dying at home under HC ($20,113 vs. $10,803). Of demographic groups measured, only black race and a lymphoma diagnosis had <50% hospice enrollment for three days or more before death. Conclusions: This study reinforces previous studies regarding costs in the last 30 days of life. The graphic representation highlights the dollar cost and the costs of lost opportunity. Using these data to improve communication, addressing socioeconomic support, and formal palliative care integration are potential strategies to improve care.

So Much Data, So Little Knowledge: Using Formal Logic to Aggregate Data and Interpret Information.

Formal logic is the use of symbols to structure how we make inferences such that the structure can be applied beyond specific cases. The structure of clinical trials and the values equation (value = outcomes/cost) lend themselves to evaluation using formal logic. Doing this demonstrates the unique position of randomized clinical trials as a defensible format for gathering information and identifies the shortcomings of historical controls and meta-analyses and retrospective studies using large databases. A practical example using literature on maintenance therapy in metastatic colorectal cancer is assessed. It is important to emphasize that value will be relative to a viewpoint, with many interested parties having competing values. This underscores the place of physicians and professional societies as putting patient values first.

Three-Year Results of a Medicare Advantage Cancer Management Program.

PURPOSE: Reform of cancer care delivery seeks to control costs while improving quality. Texas Oncology collaborated with Aetna to conduct a payer-sponsored program that used evidence-based treatment pathways, a disease management call center, and an introduction to advance care planning to improve patient care and reduce total costs. METHODS: From June 1, 2013, to May 31, 2016, 746 Medicare Advantage patients with nine common cancer diagnoses were enrolled. Patients electing for patient support services were telephoned by oncology nurses who assessed symptoms and quality of life and introduced advance care planning. Shared cost savings were determined by comparing the costs of drugs, hospitalization, and emergency room use for 509 eligible patients in the study group with a matched cohort of 900 Medicare Advantage patients treated by non-Texas Oncology providers. Physician adherence to treatment pathways and performance and quality metrics were evaluated. RESULTS: During the 3 years of the study, the cumulative cost savings were $3,033,248, and savings continued to increase each year. Drug cost savings per patient per treatment month were $1,874 (95% CI, $1,373 to $2,376; P < .001) after adjusting for age, diagnosis, and study year. Solid tumors contributed most of the savings; hematologic cancers showed little savings. For years 1, 2, and 3, adherence to treatment pathways was 81%, 84%, and 90%, patient satisfaction with patient support services was 94%, 93%, and 94%, and hospice enrollment was 55%, 57%, and 64%, respectively. CONCLUSION: A practice-based program supported by a payer sponsor can reduce costs while maintaining high adherence to treatment pathways and patient satisfaction in older patients.

The Affordable Care Act and Cancer Care Delivery.

The Affordable Care Act (ACA) has reformed US health care delivery through insurance coverage expansion, experiments in payment design, and funding for patient-centered clinical and health care delivery research. The impact on cancer care specifically has been far reaching, with new ACA-related programs that encourage coordinated, patient-centered, cost-effective care. Insurance expansions through private exchanges and Medicaid, along with preexisting condition clauses, have helped more than 20 million Americans gain health care coverage. Accountable care organizations, oncology patient-centered medical homes, and the Oncology Care Model-all implemented through the Center for Medicare & Medicaid Innovation-have initiated an accelerating shift toward value-based cancer care. Concurrently, evidence for better cancer outcomes and improved quality of cancer care is starting to accrue in the wake of ACA implementation.

If We Don't Ask, Our Patients Might Never Tell: The Impact of the Routine Use of a Patient Values Assessment.

PURPOSE: Good communication can be associated with better end-of-life outcomes. The US Oncology Network developed and tested a Values Assessment (VA) for facilitating advance care planning (ACP). The results of the first 1,268 patients are reported. METHODS: The VA consists of 10 questions of the format "How valuable is it to me to…" (eg, "...know that I am not a burden to my family, friends, or helpers?"). Responses were on a four-point scale from unsure to very valuable. VA data on 1,286 patients with metastatic cancer from April 1, 2013, to July 31, 2015, were extracted from the electronic health record, including demographics, diagnosis, stage, chemotherapy, and outcomes (hospice enrollment, place of death). These demographics were compared by using the χ2 or Fisher's exact test or the Wilcoxon rank sum test for continuous variables. RESULTS: A total of 1,268 patients completed the VA (56.7% were ≥ 65 years of age, 57.8% completed advance directives [ADs]). There were 438 deaths of which 308 had a place of death or a hospice enrollment recorded. Of these, 78% died at home or inpatient hospice; 14.6% died in the hospital. Hospice enrollment with ADs was 76.1% and without, 60.9%. Median length of stay in hospice was 21 days with ADs versus 12.5 days without. Chemotherapy in the last 14 days of life was 8.8% with ADs and 15.5% without. The VA was well accepted by patients. CONCLUSION: A VA as a routine part of practice is feasible and scalable. It facilitates ACP discussions that lead to ADs. The results suggest that VA and ACP lead to less-aggressive care at the end of life.

Improving incidence of code status documentation through process and discipline.

Documentation of a patient's preferred code status is a critical outcome of advance care planning. Although there is agreement that code status is valuable information, little progress has been made to increase the incidence of documented code status within the medical record in an outpatient setting. Incidence of code status documentation in the community oncology setting has not been studied. In April 2013, the US Oncology Network and McKesson Specialty Health launched a new advance care planning initiative for the purpose of promoting conversations between clinicians and patients regarding end-of-life care preferences. The program-My Choices, My Wishes-provides a systematic approach for learning about and documenting a patient's values and goals for care in the electronic health record. Code status documentation is one of several program performance measures. During the 14-month period from August 1, 2013, through September 30, 2014, collective sites participating in My Choices, My Wishes included discrete code status documentation within the medical record for 5,467 patients with metastatic disease. Although much work remains, early results show promise for improvement in incidence of code status documentation within health records in the outpatient setting.

Lung cancer: a cost and outcome study based on physician practice patterns.

Chemotherapy is now an acceptable treatment for selected patients with non-small-cell lung cancer. With the wide assortment of cytotoxic and supportive-care drugs, there are opportunities for assessing the value of various treatment approaches. This study was undertaken to assess variations in treatment patterns in a large oncology group with emphasis on costs incurred and survival. A total of 1215 patients seen in 1996 by Medical Oncologists (a community-based private practice) were identified as new lung cancer patients by review of billing data. Of these, 858 received chemotherapy and were evaluated for charges. Three hundred were evaluated for charges, hospice care, and survival. Differences in practice patterns for physicians and the causes of those differences were assessed. Differences in survival, charges, and hospice care for those patients who were seen by high-charge and low-charge physicians were measured. Clear differences emerged in practice patterns for these Medical Oncologists. Higher charges were associated with higher average number of chemotherapy cycles given, greater use of second- and third-line chemotherapy and greater use of support drugs, particularly G-CSF and erythropoietin. For stage IV non-small-cell lung cancer, there was no difference in survival or in hospice utilization for the two groups. For all patients combined, there was no significant survival difference. There may be as much as 100% difference in costs incurred for lung cancer chemotherapy based on variations in practice patterns alone without a measurable survival difference. These results suggest approaches for cost-minimization and disease management. These suggestions have been reinforced by recent clinical data and guideline development.

Opening the black box: the impact of an oncology management program consisting of level I pathways and an outbound nurse call system.

PURPOSE: The Innovent Oncology Program aims to improve the value of cancer care delivered to patients. McKesson Specialty Health and Texas Oncology (TXO) collaborated with Aetna to launch a pilot program. The study objectives were to evaluate the impact of Innovent on Level I Pathway compliance, implement the Patient Support Services program, and measure the rate and costs associated with chemotherapy-related emergency room (ER) visits and hospital admissions. PATIENTS AND METHODS: This was a prospective, nonrandomized evaluation of patients enrolled in Innovent from June 1, 2010, through May 31, 2012. Data from the iKnowMed electronic health record, the McKesson Specialty Health financial data warehouse, and Aetna claims data warehouse were analyzed. RESULTS: A total of 221 patients were included and stratified according to disease and age groups; 76% of ordered regimens were on pathway; 24% were off pathway. Pathway adherence improved from TXO baseline adherence of 63%. Of the 221 patients, 81% enrolled in PSS. Within the breast, colorectal, and lung cancer groups, 14% and 24% of patients had an ER visit and in-patient admission (IPA; baseline) versus 10% and 18% in Innovent, respectively; average in-patient days decreased from 2.1 to 1.2 days, respectively. Total savings combined for the program was $506,481. CONCLUSION: Implementation of Innovent positively affected patient care in several ways: Fewer ER visits and IPAs occurred, in-patient days decreased, cancer-related use costs were reduced, and on-pathway adherence increased.

Impact of payment reform on chemotherapy at the end of life.

OBJECTIVES: To assess the impact of 2005 and 2006 reductions in chemotherapy reimbursement, mandated in the Medicare Modernization Act, on patterns of chemotherapy receipt in the last 14 days of life. PATIENTS AND METHODS: Included in the study were Medicare beneficiaries dying with poor-prognosis cancer from 2003 to 2007. We compared pre- and postreform probability and frequency of chemotherapy receipt in the last 14 days of life, a validated quality measure, using linear models. We assessed changes in chemotherapy use in physician offices (where prescribing is often directly linked to physician income) and hospital outpatient departments (where the link is indirect and likely weaker). RESULTS: Among patients receiving chemotherapy in the 6 months before death in physicians' offices before the policy implementation (2003 to 2004), 18% received chemotherapy in the last 14 days of life. Those dying after implementation (2006 to 2007) were 3.5 percentage points (95% confidence interval [CI], -5.4 to -1.6; P <.001), or 20%, less likely to receive chemotherapy in the 14 days before death than those dying before implementation. By contrast, there was no significant change in the percentage of patients receiving chemotherapy in the last 14 days of life in hospital outpatient departments between 2003 and 2004 and between 2006 and 2007. CONCLUSIONS: In physician offices, where drugs generate the majority of revenue, and prescribing patterns can determine physician income, use of chemotherapy at the end of life fell significantly after reimbursement reductions; no concurrent change occurred in hospital outpatient departments. These results suggest that payment reform may be used to better align appropriate financial incentives with better quality of care.

Impact of payment reform on chemotherapy at the end of life.

PURPOSE: To assess the impact of 2005 and 2006 reductions in chemotherapy reimbursement, mandated in the Medicare Modernization Act, on patterns of chemotherapy receipt in the last 14 days of life. PATIENTS AND METHODS: Included in the study were Medicare beneficiaries dying with poor-prognosis cancer from 2003 to 2007. We compared pre- and postreform probability and frequency of chemotherapy receipt in the last 14 days of life, a validated quality measure, using linear models. We assessed changes in chemotherapy use in physician offices (where prescribing is often directly linked to physician income) and hospital outpatient departments (where the link is indirect and likely weaker). RESULTS: Among patients receiving chemotherapy in the 6 months before death in physicians' offices before the policy implementation (2003 to 2004), 18% received chemotherapy in the last 14 days of life. Those dying after implementation (2006 to 2007) were 3.5 percentage points (95% CI, -5.4 to -1.6; P < .001), or 20%, less likely to receive chemotherapy in the 14 days before death than those dying before implementation. By contrast, there was no significant change in the percentage of patients receiving chemotherapy in the last 14 days of life in hospital outpatient departments between 2003 and 2004 and 2006 to 2007. CONCLUSION: In physician offices, where drugs generate the majority of revenue and prescribing patterns can determine physician income, use of chemotherapy at the end of life fell significantly after reimbursement reductions; no concurrent change occurred in hospital outpatient departments. These results suggest that payment reform may be used to better align appropriate financial incentives with better quality of care.