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BACKGROUND: The onset of the COVID-19 pandemic challenged healthcare providers to adapt their models of care and leverage technology to continue to provide necessary care while reducing the likelihood of exposure. One setting that faced a unique set of challenges and opportunities was free and charitable clinics. In response to the emerging pandemic, The North Carolina Association for Free and Charitable Clinics (NCAFCC) offered their 66 member clinics access to a telehealth platform, free of charge. OBJECTIVE: This paper explores the varied perspectives of leaders in the NCAFCC member clinics regarding the implementation of telehealth services to facilitate continuity of care for patients during the height of the pandemic. DESIGN: This qualitative study is part of a broader research effort to understand and contextualize the experience of implementing and using telehealth services by North Carolina free and charitable clinics during and after the COVID-19 pandemic. The research team conducted 13 key informant interviews and employed thematic analysis and grounded theory to explore critical themes and construct a model based on the CFIR to describe the use of telehealth in free and charitable clinics. RESULTS: Twelve clinic managers and executive directors from free and charitable clinics across the state participated in the key informant interviews providing their unique perspective on the experience of implementing telehealth services in a free and charitable clinic environment during the COVID-19 pandemic. When examined within the lens of the consolidated framework for implementation research (CFIR), 3 key themes emerged from the key informant interviews: mission driven patient centered care, resilience and resourcefulness, and immediate implementation. CONCLUSIONS: This study aligns with existing literature regarding telehealth implementation across other safety net provider settings and highlights the key implementation factors, organizational elements, provider perspectives, and patient needs that must collectively be considered when implementing new technologies, especially in a low-resource, high need healthcare setting. The study showcases the implementation climate, resourcefulness, and mission driven approach that allowed many NCAFCC clinics to respond to an emergent situation by adopting and implementing a telehealth platform in a period of 2 weeks or less.

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Purpose: The emergence of the COVID-19 pandemic led health care systems and providers worldwide to rapidly adopt telehealth solutions to minimize risk and comply with isolation mandates. This article explores telehealth utilization trends in North Carolina (NC) free and charitable clinics-an ambulatory health care delivery setting where traditional third-party reimbursement policies are not a primary consideration. Methods: We surveyed NC free and charitable clinic administrators regarding clinic decisions to adopt an externally sponsored telehealth system, what services are provided by telehealth, clinic implementation processes, which populations used telehealth, how telehealth was incorporated into current clinic workflows, and perceptions of telehealth outcomes. Findings: Telehealth was rapidly adopted among free and charitable clinics after the COVID-19 outbreak. Reasons for implementing telehealth included the ability to continue providing services during a public health emergency and to increase access to patients. However, clinics report that telehealth utilization has dropped significantly since the initial pandemic surge. Patient and provider preferences for in-person services are a common reason cited for this drop. Free and charitable clinics report a strong interest in continuing to deliver services through telehealth. The majority reported continuing to offer telehealth services, but primarily as a supplement to in-person visits rather than as a replacement. They perceive that implementing telehealth has increased access to care but are less certain about the impact on cost of care and patient satisfaction. However, clinic administrators believe improvements in interoperability with other data systems, workflows, scheduling, and care delivery approaches are needed to achieve telehealth's fullest utilization. Conclusion: Telehealth can play a significant role in expanding access to services in the free and charitable clinic setting. However, continued refinements in the technology to facilitate integration with other systems and workflow processes are needed to reach its full potential.

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There is a body of Implementation and Dissemination research describing the importance of "context"-the characteristics describing the setting where a process or innovation occurs-when evaluating delivery, outcomes and cost of health services. These contextual factors, which can occur at the system, organization, or provider level, may either facilitate or erect barriers to the utilization of evidence-based practices and the outcomes achieved. This paper examines the influence of organizational structure and operating environment characteristics of where inpatient health care is delivered, controlling for patient and provider characteristics, on health services delivery and outcomes achieved. We used inpatient cost-of-care to represent the bundle of services provided to patients receiving primary knee and hip replacement procedures. Data includes patient level data from discharge records for 62 140 knee replacements and 42 392 hip replacements from the 2015 AHRQ Healthcare Cost and Utilization Project State Inpatient Discharge database and hospital characteristics from the 2015 American Hospital Association survey. Multi-level linear estimation models controlling for patient and payer characteristics were employed to assess the impact of specific organizational and operating environment factors. We found that although patient and payer characteristics significantly impacted the inpatient cost of care, there is significant variation between hospitals and among physicians within a hospital beyond what can be explained by patient, payer and local price effect characteristics. Organizational and physician characteristics that had the most significant impact on cost of care included the volume of services provided, urban location, and for-profit ownership. These factors can inform future policy and program design and evaluation.

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PURPOSE: There is uncertainty about when personalized medicine tests provide economic value. We assessed evidence on the economic value of personalized medicine tests and gaps in the evidence base. METHODS: We created a unique evidence base by linking data on published cost-utility analyses from the Tufts Cost-Effectiveness Analysis Registry with data measuring test characteristics and reflecting where value analyses may be most needed: (i) tests currently available or in advanced development, (ii) tests for drugs with Food and Drug Administration labels with genetic information, (iii) tests with demonstrated or likely clinical utility, (iv) tests for conditions with high mortality, and (v) tests for conditions with high expenditures. RESULTS: We identified 59 cost-utility analyses studies that examined personalized medicine tests (1998-2011). A majority (72%) of the cost/quality-adjusted life year ratios indicate that testing provides better health although at higher cost, with almost half of the ratios falling below $50,000 per quality-adjusted life year gained. One-fifth of the results indicate that tests may save money. CONCLUSION: Many personalized medicine tests have been found to be relatively cost-effective, although fewer have been found to be cost saving, and many available or emerging medicine tests have not been evaluated. More evidence on value will be needed to inform decision making and assessment of genomic priorities.

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OBJECTIVES: To calculate the costs associated with implementing and operating an inpatient bar-code medication administration (BCMA) system in the community hospital setting and to estimate the cost per harmful error prevented. STUDY DESIGN: This is a retrospective, observational study. Costs were calculated from the hospital perspective and a cost-consequence analysis was performed to estimate the cost per preventable adverse drug event averted. METHODS: Costs were collected from financial records and key informant interviews at 4 not-for profit community hospitals. Costs included direct expenditures on capital, infrastructure, additional personnel, and the opportunity costs of time for existing personnel working on the project. The number of adverse drug events prevented using BCMA was estimated by multiplying the number of doses administered using BCMA by the rate of harmful errors prevented by interventions in response to system warnings. Our previous work found that BCMA identified and intercepted medication errors in 1.1% of doses administered, 9% of which potentially could have resulted in lasting harm. RESULTS: The cost of implementing and operating BCMA including electronic pharmacy management and drug repackaging over 5 years is $40,000 (range: $35,600 to $54,600) per BCMA-enabled bed and $2000 (range: $1800 to $2600) per harmful error prevented. CONCLUSIONS: BCMA can be an effective and potentially cost-saving tool for preventing the harm and costs associated with medication errors.

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The objective of this paper is to provide an overview of economic evaluation of personalized medicine, focusing particularly on the use of cost-effectiveness analysis and other methods of valuation. We draw on insights from the literature and our work at the University of California, San Francisco Center for Translational and Policy Research on Personalized Medicine (TRANSPERS). We begin with a discussion of why personalized medicine is of interest and challenges to adoption, whether personalized medicine is different enough to require different evaluation approaches, and what is known about the economics of personalized medicine. We then discuss insights from TRANSPERS research and six areas for future research: Develop and Apply Multiple Methods of Assessing Value Identify Key Factors in Determining the Value of Personalized Medicine Use Real World Perspectives in Economic Analyses Consider Patient Heterogeneity and Diverse Populations in Economic Analyses Prepare for Upcoming Challenges of Assessing Value of Emerging Technologies Incorporate Behavioral Economics into Value Assessments.

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OBJECTIVE: This study aimed to examine the effects of participation in staff nurse-led practice councils on nurse job satisfaction and professional development. BACKGROUND: Although evidence-based practice (EBP) has become a key component of improving the quality of care, few studies have examined how implementation of staff nurse led councils model affect the involved nurses. METHODS: A 3-stage evaluation involving ethnography, semi-structured phenomenological private interviews and a 10-item survey were conducted with nurses, managers and executives participating in or involved with EBP councils tasked with improving patient outcomes at 6 community hospitals in a single non-profit hospital system. RESULTS: Five themes were identified as outcomes: empowerment, meaningfulness, leadership growth, exposure to quality improvement, and vision. CONCLUSIONS: Staff-led councils have the potential to improve quality of care, job satisfaction, vision and leadership provided that managers and executives are sufficiently prepared to work with and support the councils.

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Engaging bedside clinicians, especially nurses, is essential for the success of sustainable process improvement programs and thus for improving the quality of health care. Studies have shown that properly implemented professional councils can be effective in engaging and empowering bedside clinicians to create lasting and meaningful improvements. This case study describes a 5-year program to implement and operate staff-led councils to lead evidence-based practice (EBP) quality improvement initiatives at 6 community hospitals. The outcomes presented in this case study demonstrate that staff-led councils have the potential to improve patient safety and quality of care as evidenced by observed reductions in ventilator-associated pneumonias, central line-associated bloodstream infections, and mortality from acute myocardial infarction and severe sepsis.

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PURPOSE: The effectiveness of a program to improve adherence to best-practice guidelines for venous thromboembolism (VTE) risk assessment and prevention in a community hospital setting was evaluated. SUMMARY: Variation in the use of best-practice guidelines for VTE risk assessment and prevention with regard to the frequency of VTE risk assessment and the risk score assigned, as well as the communication of the risk of VTE and the need for prophylaxis to treating physicians, was found. To improve adherence to established guidelines, the responsibilities of a nurse case manager were expanded to serve as a single point of contact who was accountable for identifying high-risk patients and advocating for appropriate pharmacologic prophylaxis in the absence of contraindications. To facilitate the role of the nurse case manager, an automated VTE-risk-assessment tool was developed to reliably identify high-risk patients in real time. This intervention was evaluated from January 1 to June 30, 2010. Before the intervention, contraindications to anticoagulation were reported for 19.1% of high-risk patients not receiving prophylaxis and pharmacologic prophylaxis was ordered for 47.9% of high-risk patients without contraindications. During the course of the intervention, contraindications to anticoagulation were reported for 36.2% of high-risk patients not receiving prophylaxis and pharmacologic prophylaxis was ordered for 64.9% of high-risk patients without contraindications. CONCLUSION: The appointment of a nurse case manager trained in anticoagulation and the development of an automated VTE-risk-assessment tool to identify patients at high risk of VTE were associated with improved adherence to best-practice guidelines for VTE risk assessment and prevention.

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Billing and insurance-related functions have been reported to consume 14 percent of medical group revenue, but little is known about the costs associated with performing specific activities. We conducted semistructured interviews, observed work flows, analyzed department budgets, and surveyed clinicians to evaluate these activities at a large multispecialty medical group. We identified 0.67 nonclinical full-time-equivalent (FTE) staff working on billing and insurance functions per FTE physician. In addition, clinicians spent more than thirty-five minutes per day performing these tasks. The cost to medical groups, including clinicians' time, was at least $85,276 per FTE physician (10 percent of revenue).

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PURPOSE: The severity of medication administration errors detected by a bar-code medication administration (BCMA) system was studied. METHODS: A panel of six health care providers reviewed medication administration error scenarios created from BCMA error logs at six community hospitals. Each scenario was rated on the potential to cause patient harm, taking into account the severity of the potential outcome and the probability that the patient would be harmed. A severity score for each error was determined by averaging the individual reviewers' scores. RESULTS: The majority of the medication administration errors identified by the BCMA system were judged to be benign; 1% of the errors reviewed were rated as having the potential to result in a severe or life-threatening adverse event, 8% were judged to have the potential to produce moderate adverse effects, and 91% were expected to produce minimal, if any, clinical effects. Medication errors due to a dose being administered when there was no corresponding order in the computer system were significantly more likely to produce moderate or severe outcomes than other types of medication errors. Errors that involved medications designated as high-alert drugs were also more likely to produce moderate or severe adverse events than non-high-alert drugs. CONCLUSION: The majority of medication administration errors detected by a BCMA system were judged to be benign and pose minimal safety risks; however, the numbers and severity of medication administration errors that occur despite the use of a BCMA system suggest that there are opportunities to improve these systems and how the information they generate is used.

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BACKGROUND: Genetic testing for long QT syndrome (LQTS) has been available in a research setting for the past decade, and a commercial test has recently become available. However, the costs and effectiveness of genetic testing have not been estimated. OBJECTIVES: The purpose of this study was to conduct a cost-effectiveness analysis of genetic testing in the management of patients who have or are suspected to have familial LQTS. METHODS: We examined the incremental cost-effectiveness of genetic testing compared with no genetic testing for symptomatic index cases and how this varied according to changes in assumptions and data inputs. Data were obtained from the published literature and a clinical cohort. RESULTS: We found that genetic testing is more cost-effective than not testing for symptomatic index cases at an estimated cost of 2,500 US dollar per year of life saved. These results were generally robust, although they were sensitive to some data inputs such as the cost of testing and the mortality rate among untreated individuals with LQTS. CONCLUSION: A genetic test for familial LQTS is cost-effective relative to no testing, given our assumptions about the population to be tested and the relevant probabilities and costs. The primary benefit of testing is to more accurately diagnose and treat individuals based on a combination of clinical scores and test results. Future economic analyses of testing for familial LQTS should consider the potential benefits of genetic testing of broader populations, including family members.

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In this qualitative evaluation of 14 U.S. health insurers' coverage policies concerning mifepristone-induced medical abortion, the findings suggest that a significant proportion of health plans do not include evidence-based clinical information obtained from recent research, data, and practice. This omission may hinder the adoption of new, evidence-based protocols for medical abortion by physicians. A model coverage policy that contains comprehensive clinical information regarding appropriate clinical regimens for mifepristone is provided as an example for insurers and others in the field.

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OBJECTIVES: To determine the potential impact of genetic testing and pharmacogenomics on healthcare delivery and costs. STUDY DESIGN: Literature review. METHODS: We examined 3 examples: (1) BRCA1/2 testing for breast cancer risk, (2) HER2/neu overexpression testing to guide drug treatment in women with breast cancer, and (3) CYP2C9 testing before the use of the anticoagulant warfarin. We discussed each genetic testing example from the perspective of the patient, provider, insurer, industry, government, and society. RESULTS: The expanded use of genetic information offers many potential clinical benefits, but also many economic challenges. One of those challenges will be managing the impact of genetic testing on healthcare delivery and costs. CONCLUSIONS: Systematic, evidence-based technology assessments and economic evaluations will have to be used to guide the incorporation of genomics into clinical practice. More research also will be needed to assess patient preferences and willingness to pay for genomic technologies; how providers can assess and use genomic technologies; and how the industry, insurers, and government can best balance the relevant costs and benefits.

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OBJECTIVES: To explore the characteristics of individuals who are dissatisfied with their health plan, assess what aspects of the medical care experience are associated with plan dissatisfaction, and examine how this association varies according to plan type. STUDY DESIGN: Retrospective observational study using the 1996 Medical Expenditure Panel Survey. METHODS: Unwillingness to recommend a health plan to others was used as a measure of overall plan dissatisfaction. Descriptive statistics were calculated to characterize the dissatisfied population. Logistic regressions and predicted probabilities controlling for personal characteristics were calculated to determine the association between plan or provider attribute and unwillingness to recommend a plan. RESULTS: We found no personal characteristics that significantly differentiated individuals who reported their family was unwilling to recommend a health plan from those who were willing. The largest predictors of unwillingness to recommend a plan were dissatisfaction with choice of providers and preventive services coverage; in contrast, provider and personal characteristics were not significant predictors of dissatisfaction. We estimated the probability of being unwilling to recommend a health plan was 38% for individuals dissatisfied with the choice of providers and 34% for those dissatisfied with preventive services coverage. Although provider attributes were not found to be predictors of plan dissatisfaction for the entire sample, they were predictors of dissatisfaction for HMO and multiple plan members. CONCLUSIONS: Enrollee dissatisfaction with the choice of providers and preventive services coverage are major predictors of health plan dissatisfaction. Managers concerned about plan satisfaction may want to examine enrollee assessments of these measures.

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OBJECTIVES: To examine whether there are differential impacts of patient cost sharing and health plan organizational characteristics on the use of a recommended cancer screening service (mammography) versus a controversial cancer screening service (prostate cancer screening [PCS]). STUDY DESIGN: Observational cohort using the 1996 Medical Expenditure Panel Survey. PATIENTS AND METHODS: A nationally representative sample of privately insured individuals was examined. Outcome measures were the receipt of mammography and PCS. Logistic regression was used to assess the impact of patient cost sharing and health plan organizational characteristics on the receipt of mammography and PCS, controlling for other covariates. RESULTS: Patient cost sharing and gatekeeper requirements were strong predictors of PCS but were statistically insignificant predictors of mammography. Men in health plans with a copayment over dollar 10 (odds ratio [OR] = 0.38, 95% confidence interval [CI] = 0.19-0.78) or with deductibles over dollar 250 (OR = 0.38, 95% CI = 0.23-0.62) were significantly less likely to receive PCS than men in plans with no or lower copayments and deductibles. Men in gatekeeper plans were less likely to receive PCS than those without gatekeepers (OR = 0.48, 95% CI = 0.29-0.81). CONCLUSIONS: We found the impact of cost sharing on utilization is different between mammography and PCS. Prostate cancer screening utilization appears to respond to financial incentives while mammography utilization does not. The use of copayments, deductibles, and gatekeepers may discourage controversial services but may not have an adverse effect on more recommended services. These findings have implications for the design of insurance benefits and plan organizational structure.

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OBJECTIVE: There is widespread debate over whether health plans should require enrollees to use "gatekeepers," which are primary care providers that coordinate care and control access to specialists. However, little is known about whether health plan gatekeeper requirements improve or reduce quality-of-care. Our objective was to examine whether gatekeeper requirements are associated with the utilization of cancer screening for breast, cervical, and prostate cancer. DATA SOURCES: Three linked sources (N = 13,534): (1) 1996 Medical Expenditure Panel Survey (MEPS) Household Survey, a nationally representative, ongoing survey sponsored by the Agency for Healthcare Research and Quality; (2) 1996 MEPS Health Insurance Plan Abstraction, which codes data from health plan booklets obtained from privately insured respondents, and (3) 1995 National Health Interview Survey. STUDY DESIGN/DATA COLLECTION: Cross-sectional, multivariate logistic regression analysis using secondary data. PRINCIPAL FINDINGS: We found in multivariate analyses that women in gatekeeper plans were significantly more likely to obtain mammography screening (Odds Ratio [OR] = 1.22, 95 percent Confidence Interval [CI] 1.07-1.40), clinical breast examinations (OR = 1.39, 95 percent CI 1.23-1.57), and Pap smears (OR = 1.33, 95 percent CI 1.16-1.52) than women not in gatekeeper plans. In contrast, gatekeeper requirements were not associated with prostate cancer screening (OR = 1.11, 95 percent CI 0.93-1.33). We found no association between screening utilization and aggregate plan types (HMO, POS, PPO, FFS). CONCLUSIONS: Gatekeeper requirements are associated with higher utilization of widely recommended cancer screening procedures, but not with utilization of a less uniformly recommended cancer screening procedure. Researchers should consider the analysis of specific plan characteristics rather than aggregate plan types in conducting future research, and insurers and policymakers should consider the potential benefits of gatekeepers with respect to preventive care when designing health plans and legislation.

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Methods of economic evaluation, especially cost-effectiveness analysis and cost-benefit analysis, are widely used to examine new healthcare technologies. However, few economic evaluations of pharmacogenomics have been conducted, and pharmacogenomic researchers may be unfamiliar with how to review or conduct these analyses. This review provides an overview of the methods of economic evaluation and examples of where they have been applied to pharmacogenomics. We discuss the steps in conducting a cost-effectiveness or cost-benefit analysis, demonstrating these steps using specific examples from the pharmacogenomics literature.

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