Assessing the transition from intravenous to subcutaneous delivery of rituximab: Benefits for payers, health care professionals, and patients with lymphoma.

Subcutaneous (SC) administration of rituximab provides an opportunity for reduced patient treatment burden and increased healthcare efficiencies as an alternative to intravenous (IV) rituximab. There is minimal evidence comparing costs associated with SC and IV rituximab in a US setting. This research assessed the impact of transitioning patients from IV to SC rituximab for treatment of non-Hodgkin's lymphoma (NHL) from the US payer, provider, and patient perspective. We developed a model to estimate cost differences for transitioning 20% of a patient cohort from IV to SC rituximab. We included patients with incident diffuse large B-cell lymphoma, incident and recurrent follicular lymphoma, and incident and recurrent chronic lymphocytic leukemia. In the model, each patient received the same number of doses and that there was no difference in discontinuation between cohorts due to non-inferior efficacy and a similar safety profile. Model inputs were collected from published literature and publicly available data. Scenario analyses tested the impact of availability of low-cost biosimilars. In the base case (1,000,000 covered lives), we estimated a total of 157 patients, with 769 total drug administrations. A transition of 20% of patients from IV to SC was projected to generate $153,000 in payer savings, increase provider capacity by 270 hours, and free 470 hours of patient time. Scenario analyses suggest SC administration will be cost saving for payers even with a market where biosimilars approach 50% market share. A 20% transition to SC rituximab in a single cohort of patients has the potential to generate significant US health system value in the form of payer savings, increased practice capacity, and patient time.

Effects of a multifaceted intervention to promote the use of intravenous iron sucrose complex instead of ferric carboxymaltose in patients admitted for more than 24 h.

PURPOSE: Although more practical for use, the impact of ferric carboxymaltose (FCM) on the hospital budget is considerable, and intravenous iron sucrose complex (ISC) represents a cost-saving alternative for the management of iron deficiency anemia in patients during hospitalization. The Drug Committee decided to reserve FCM for day hospitalizations and contraindications to ISC, especially allergy. ISC was available for prescription for all other situations. METHODS: The impact of a multifaceted intervention promoting a switch from FCM to ISC was evaluated using an interrupted time series model with segmented regression analysis. The standardized rate of the dispensing of FCM, ISC, and oral iron by the hospital pharmacy, as well as the rate of the dispensing of packed red blood cells and the number of biological iron status measurements, was analyzed before and after the intervention. RESULTS: There was an immediate decrease in FCM consumption following the intervention, with a reduction of 88% (RR: 0.12 [CI95% 0.10 to 0.15]). Conversely, there was a large increase in ISC use (RR: 5.1 [CI95% 4.4 to 5.9]). We did not observe a prescription shift to packed red blood cells or oral iron after the intervention. The time series analysis showed the frequency of iron status testing to remain stable before and after. The direct savings for intravenous iron for 8 months were 187,417.54 €. CONCLUSION: Our intervention to lower the impact of intravenous iron therapy on the hospital budget was effective.

Costs of using evidence-based implementation strategies for behavioral health integration in a large primary care system.

OBJECTIVE: To describe the cost of using evidence-based implementation strategies for sustained behavioral health integration (BHI) involving population-based screening, assessment, and identification at 25 primary care sites of Kaiser Permanente Washington (2015-2018). DATA SOURCES/STUDY SETTING: Project records, surveys, Bureau of Labor Statistics compensation data. STUDY DESIGN: Labor and nonlabor costs incurred by three implementation strategies: practice coaching, electronic health records clinical decision support, and performance feedback. DATA COLLECTION/EXTRACTION METHODS: Personnel time spent on these strategies was estimated for five broad roles: (a) project leaders and administrative support, (b) practice coaches, (c) clinical decision support programmers, (d) performance metric programmers, and (e) primary care local implementation team members. PRINCIPAL FINDING: Implementation involved 286 persons, 18 131 person-hours, costing $1 587 139 or $5 per primary care visit with screening or $38 per primary care visit identifying depression, suicidal thoughts and/or alcohol or substance use disorders, in a single year. The majority of person-hours was devoted to project leadership (35%) and practice coaches (34%), and 36% of costs were for the first three sites. CONCLUSIONS: When spread across patients screened in a single year, BHI implementation costs were well within the range for commonly used diagnostic assessments in primary care (eg, laboratory tests). This suggests that implementation costs alone should not be a substantial barrier to population-based BHI.

Atrial Fibrillation Screen, Management, and Guideline-Recommended Therapy in the Rural Primary Care Setting: A Cross-Sectional Study and Cost-Effectiveness Analysis of eHealth Tools to Support All Stages of Screening.

BACKGROUND Internationally, most atrial fibrillation (AF) management guidelines recommend opportunistic screening for AF in people ≥65 years of age and oral anticoagulant treatment for those at high stroke risk (CHA2DS2-VA≥2). However, gaps remain in screening and treatment. METHODS AND RESULTS General practitioners/nurses at practices in rural Australia (n=8) screened eligible patients (≥65 years of age without AF) using a smartphone ECG during practice visits. eHealth tools included electronic prompts, guideline-based electronic decision support, and regular data reports. Clinical audit tools extracted de-identified data. Results were compared with an earlier study in metropolitan practices (n=8) and nonrandomized control practices (n=69). Cost-effectiveness analysis compared population-based screening with no screening and included screening, treatment, and hospitalization costs for stroke and serious bleeding events. Patients (n=3103, 34%) were screened (mean age, 75.1±6.8 years; 47% men) and 36 (1.2%) new AF cases were confirmed (mean age, 77.0 years; 64% men; mean CHA2DS2-VA, 3.2). Oral anticoagulant treatment rates for patients with CHA2DS2-VA≥2 were 82% (screen detected) versus 74% (preexisting AF)(P=NS), similar to metropolitan and nonrandomized control practices. The incremental cost-effectiveness ratio for population-based screening was AU$16 578 per quality-adjusted life year gained and AU$84 383 per stroke prevented compared with no screening. National implementation would prevent 147 strokes per year. Increasing the proportion screened to 75% would prevent 177 additional strokes per year. CONCLUSIONS An AF screening program in rural practices, supported by eHealth tools, screened 34% of eligible patients and was cost-effective. Oral anticoagulant treatment rates were relatively high at baseline, trending upward during the study. Increasing the proportion screened would prevent many more strokes with minimal incremental cost-effectiveness ratio change. eHealth tools, including data reports, may be a valuable addition to future programs. REGISTRATION URL: https://www.anzctr.org.au. Unique identifier: ACTRN12618000004268.

Reducing Unnecessary Phlebotomy Testing Using a Clinical Decision Support System.

INTRODUCTION: Reducing unnecessary tests reduces costs without compromising quality. We report here the effectiveness of a clinical decision support system (CDSS) on reducing unnecessary type and screen tests and describe, estimated costs, and unnecessary provider ordering. METHODS: We used a pretest posttest design to examine unnecessary type and screen tests 3 months before and after CDSS implementation in a large academic medical center. The clinical decision support system appears when the test order is initiated and indicates when the last test was ordered and expires. Cost savings was estimated using time-driven activity-based costing. Provider ordering before and after the CDSS was described. RESULTS: There were 26,206 preintervention and 25,053 postintervention specimens. Significantly fewer unnecessary type and screen tests were ordered after the intervention (12.3%, n = 3,073) than before (14.1%, n = 3,691; p < .001) representing a 12.8% overall reduction and producing an estimated yearly savings of $142,612. Physicians had the largest weighted percentage of unnecessary orders (31.5%) followed by physician assistants (28.5%) and advanced practice nurses (11.9%). CONCLUSIONS: The CDSS reduced unnecessary type and screen tests and annual costs. Additional interventions directed at providers are recommended. The clinical decision support system can be used to guide all providers to make judicious decisions at the time of care.

Value-based medicine in oncology: the importance of perspective in the emerging value frameworks.

Recently, professional and healthcare-related entities have launched frameworks designed to assess the value of cancer innovations in multistakeholder decision processes. Among the most visible entities that propose and implement value frameworks in oncology are the European Society of Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), the Memorial Sloan Kettering Cancer Center (MSKCC) and the National Comprehensive Cancer Network (NCCN). However, these value frameworks have been criticized for conceptual inconsistencies, inability to include a greater variety of value criteria, and inadequate explanation of the uncertainty approach used in the modeling process. On the other hand, Multi-Criteria Decision Analysis (MCDA) is a set of methods and processes that allow the multiple criteria involved in a decision to be explicitly addressed. This approach allows the identification of relevant decision criteria, gathering of evidence based on scientific literature, attribution of weights to the criteria and scores to the evidence raised, and aggregation of the weighted scores to constitute a global metric of value. The purpose of this article is to review the main features of these value frameworks in oncology and the importance of perspective for framework readiness to support healthcare decision-making based on MCDA methodology.

Value-based medicine in oncology: the importance of perspective in the emerging value frameworks

Recently, professional and healthcare-related entities have launched frameworks designed to assess the value of cancer innovations in multistakeholder decision processes. Among the most visible entities that propose and implement value frameworks in oncology are the European Society of Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), the Memorial Sloan Kettering Cancer Center (MSKCC) and the National Comprehensive Cancer Network (NCCN). However, these value frameworks have been criticized for conceptual inconsistencies, inability to include a greater variety of value criteria, and inadequate explanation of the uncertainty approach used in the modeling process. On the other hand, Multi-Criteria Decision Analysis (MCDA) is a set of methods and processes that allow the multiple criteria involved in a decision to be explicitly addressed. This approach allows the identification of relevant decision criteria, gathering of evidence based on scientific literature, attribution of weights to the criteria and scores to the evidence raised, and aggregation of the weighted scores to constitute a global metric of value. The purpose of this article is to review the main features of these value frameworks in oncology and the importance of perspective for framework readiness to support healthcare decision-making based on MCDA methodology.

Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India.

INTRODUCTION: Rising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system. METHODS AND ANALYSIS: mWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness. ETHICS AND DISSEMINATION: The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms. TRIAL REGISTRATION: mWellcare trial is registered with Clinicaltrial.gov (Registration number NCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org).

Using the Electronic Medical Record to Reduce Unnecessary Ordering of Coagulation Studies for Patients with Chest Pain.

INTRODUCTION: Our goal was to reduce ordering of coagulation studies in the emergency department (ED) that have no added value for patients presenting with chest pain. We hypothesized this could be achieved via implementation of a stopgap measure in the electronic medical record (EMR). METHODS: We used a pre and post quasi-experimental study design to evaluate the impact of an EMR-based intervention on coagulation study ordering for patients with chest pain. A simple interactive prompt was incorporated into the EMR of our ED that required clinicians to indicate whether patients were on anticoagulation therapy prior to completion of orders for coagulation studies. Coagulation order frequency was measured via detailed review of randomly sampled encounters during two-month periods before and after intervention. We classified existing orders as clinically indicated or non-value added. Order frequencies were calculated as percentages, and we assessed differences between groups by chi-square analysis. RESULTS: Pre-intervention, 73.8% (76/103) of patients with chest pain had coagulation studies ordered, of which 67.1% (51/76) were non-value added. Post-intervention, 38.5% (40/104) of patients with chest pain had coagulation studies ordered, of which 60% (24/40) were non-value added. There was an absolute reduction of 35.3% (95% confidence interval [CI]: 22.7%, 48.0%) in the total ordering of coagulation studies and 26.4% (95% CI: 13.8%, 39.0%) in non-value added order placement. CONCLUSION: Simple EMR-based interactive prompts can serve as effective deterrents to indiscriminate ordering of diagnostic studies.

Performance Goals for an Adjunct Diagnostic Test to Reduce Unnecessary Biopsies After Screening Mammography: Analysis of Costs, Benefits, and Consequences.

PURPOSE: Because benign biopsies resulting from false-positive mammographic findings are a known harm of breast cancer screening, physicians and test manufacturers are searching for ways to reduce their frequency. The aim of this study was to estimate potential costs and consequences associated with using an adjunct diagnostic test for triaging women with suspicious mammographic findings before biopsy. METHODS: A decision model was developed to compare the use of an adjunct test before biopsy to the current standard of care for suspicious mammographic findings. The decision analysis was performed from the perspective of a national health payer, with a 1-year time horizon among women representative of the US screening population aged 40 to 79 years. Three primary outcomes were assessed: (1) incremental costs, (2) number of benign biopsies avoided, and (3) number of missed opportunities for diagnosing cancer per million women screened. Input parameters were obtained from the medical literature and expert opinion. Sensitivity analyses were performed to evaluate the effects of uncertainty in parameter estimates. RESULTS: The base-case analysis demonstrated that the use of an adjunct diagnostic test with 95% sensitivity, 75% specificity, and a cost of $1,000 would eliminate 8,127 unnecessary breast biopsies per million women screened. However, this would cost the US health care system an additional $6,462,977 and result in 255 missed opportunities for diagnosing cancer per million women screened. CONCLUSIONS: The addition of an adjunct test for triaging women for breast biopsy after abnormal findings on screening mammography would likely eliminate many unnecessary biopsies but also increase overall health care costs. This exploratory analysis highlights the fact that mammography remains a relatively inexpensive and effective breast cancer screening and diagnostic modality.

Improving early diagnosis of symptomatic cancer.

Much time, effort and investment goes into the diagnosis of symptomatic cancer, with the expectation that this approach brings clinical benefits. This investment of resources has been particularly noticeable in the UK, which has, for several years, appeared near the bottom of international league tables for cancer survival in economically developed countries. In this Review, we examine expedited diagnosis of cancer from four perspectives. The first relates to the potential for clinical benefits of expedited diagnosis of symptomatic cancer. Limited evidence from clinical trials is available, but the considerable observational evidence suggests benefits can be obtained from this approach. The second perspective considers how expedited diagnosis can be achieved. We concentrate on data from the UK, where extensive awareness campaigns have been conducted, and initiatives in the primary-care setting, including clinical decision support, have all occurred during a period of considerable national policy change. The third section considers the most appropriate patients for cancer investigations, and the possible community settings for identification of such patients; UK national guidance for selection of patients for investigation is discussed. Finally, the health economics of expedited diagnosis are reviewed, although few studies provide definitive evidence on this topic.

Evaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trial.

BACKGROUND: For most cancers, only a minority of patients have symptoms meeting the National Institute for Health and Clinical Excellence guidance for urgent referral. For gastro-oesophageal cancers, the 'alarm' symptoms of dysphagia and weight loss are reported by only 32 and 8 % of patients, respectively, and their presence correlates with advanced-stage disease. Electronic clinical decision-support tools that integrate with clinical computer systems have been developed for general practice, although uncertainty remains concerning their effectiveness. The objectives of this trial are to optimise the intervention and establish the acceptability of both the intervention and randomisation, confirm the suitability and selection of outcome measures, finalise the design for the phase III definitive trial, and obtain preliminary estimates of the intervention effect. METHODS/DESIGN: This is a two-arm, multi-centre, cluster-randomised, controlled phase II trial design, which will extend over a 16-month period, across 60 general practices within the North East and North Cumbria and the Eastern Local Clinical Research Network areas. Practices will be randomised to receive either the intervention (the electronic clinical decision-support tool) or to act as a control (usual care). From these practices, we will recruit 3000 adults who meet the trial eligibility criteria and present to their GP with symptoms suggestive of gastro-oesophageal cancer. The main measures are the process data, which include the practitioner outcomes, service outcomes, diagnostic intervals, health economic outcomes, and patient outcomes. One-on-one interviews in a sub-sample of 30 patient-GP dyads will be undertaken to understand the impact of the use or non-use of the electronic clinical decision-support tool in the consultation. A further 10-15 GPs will be interviewed to identify and gain an understanding of the facilitators and constraints influencing implementation of the electronic clinical decision-support tool in practice. DISCUSSION: We aim to generate new knowledge on the process measures regarding the use of electronic clinical decision-support tools in primary care in general and to inform a subsequent definitive phase III trial. Preliminary data on the impact of the support tool on resource utilisation and health care costs will also be collected. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN12595588 .

Reducing duplicate testing: a comparison of two clinical decision support tools.

OBJECTIVES: Unnecessary duplicate laboratory testing is common and costly. Systems-based means to avert unnecessary testing should be investigated and employed. METHODS: We compared the effectiveness and cost savings associated with two clinical decision support tools to stop duplicate testing. The Hard Stop required telephone contact with the laboratory and justification to have the duplicate test performed, whereas the Smart Alert allowed the provider to bypass the alert at the point of order entry without justification. RESULTS: The Hard Stop alert was significantly more effective than the Smart Alert (92.3% vs 42.6%, respectively; P < .0001). The cost savings realized per alert activation was $16.08/alert for the Hard Stop alert vs $3.52/alert for the Smart Alert. CONCLUSIONS: Structural and process changes that require laboratory contact and justification for duplicate testing are more effective than interventions that allow providers to bypass alerts without justification at point of computerized physician order entry.

Reducing risk with clinical decision support: a study of closed malpractice claims.

OBJECTIVE: Identify clinical opportunities to intervene to prevent a malpractice event and determine the proportion of malpractice claims potentially preventable by clinical decision support (CDS). MATERIALS AND METHODS: Cross-sectional review of closed malpractice claims over seven years from one malpractice insurance company and seven hospitals in the Boston area. For each event, clinical opportunities to intervene to avert the malpractice event and the presence or absence of CDS that might have a role in preventing the event, were assigned by a panel of expert raters. Compensation paid out to resolve a claim (indemnity), was associated with each CDS type. RESULTS: Of the 477 closed malpractice cases, 359 (75.3%) were categorized as substantiated and 195 (54%) had at least one opportunity to intervene. Common opportunities to intervene related to performance of procedure, diagnosis, and fall prevention. We identified at least one CDS type for 63% of substantiated claims. The 41 CDS types identified included clinically significant test result alerting, diagnostic decision support and electronic tracking of instruments. Cases with at least one associated intervention accounted for $40.3 million (58.9%) of indemnity. DISCUSSION: CDS systems and other forms of health information technology (HIT) are expected to improve quality of care, but their potential to mitigate risk had not previously been quantified. Our results suggest that, in addition to their known benefits for quality and safety, CDS systems within HIT have a potential role in decreasing malpractice payments. CONCLUSION: More than half of malpractice events and over $40 million of indemnity were potentially preventable with CDS.

Return on investment for vendor computerized physician order entry in four community hospitals: the importance of decision support.

BACKGROUND: In-hospital adverse events are a major cause of morbidity and mortality and represent a major cost burden to health care systems. A study was conducted to evaluate the return on investment (ROI) for the adoption of vendor-developed computerized physician oder entry (CPOE) systems in four community hospitals in Massachusetts. METHODS: Of the four hospitals, two were under one management structure and implemented the same vendor-developed CPOE system (Hospital Group A), while the other two were under a second management structure and implemented another vendor-developed CPOE system (Hospital Group B). Cost savings were calculated on the basis of reduction in preventable adverse drug event (ADE) rates as measured previously. ROI, net cash flow, and the breakeven point during a 10-year cost-and-benefit model were calculated. At the time of the study, none of the participating hospitals had implemented more than a rudimentary decision support system together with CPOE. RESULTS: Implementation costs were lower for Hospital Group A than B ($7,130,894 total or $83/admission versus $19,293,379 total or $113/admission, respectively), as were preventable ADE-related avoided costs ($7,937,651 and $16,557,056, respectively). A cost-benefit analysis demonstrated that Hospital Group A had an ROI of 11.3%, breaking even on the investment eight years following implementation. Hospital Group B showed a negative return, with an ROI of -3.1%. CONCLUSIONS: Adoption of vendor CPOE systems in community hospitals was associated with a modest ROI at best when applying cost savings attributable to prevention of ADEs only. The modest financial returns can beattributed to the lack of clinical decision support tools.

Desktop microsimulation: a tool to improve efficiency in the medical office practice.

Because the economic crisis in the United States continues to have an impact on healthcare organizations, industry leaders must optimize their decision making. Discrete-event computer simulation is a quality tool with a demonstrated track record of improving the precision of analysis for process redesign. However, the use of simulation to consolidate practices and design efficiencies into an unfinished medical office building was a unique task. A discrete-event computer simulation package was used to model the operations and forecast future results for four orthopedic surgery practices. The scenarios were created to allow an evaluation of the impact of process change on the output variables of exam room utilization, patient queue size, and staff utilization. The model helped with decisions regarding space allocation and efficient exam room use by demonstrating the impact of process changes in patient queues at check-in/out, x-ray, and cast room locations when compared to the status quo model. The analysis impacted decisions on facility layout, patient flow, and staff functions in this newly consolidated practice. Simulation was found to be a useful tool for process redesign and decision making even prior to building occupancy.

Clinical decision support for imaging in the era of the Patient Protection and Affordable Care Act.

Imaging clinical decision support (CDS) systems provide evidence for or against imaging procedures ordered within a computerized physician order entry system at the time of the image order. Depending on the pertinent clinical history provided by the ordering clinician, CDS systems can optimize imaging by educating providers on appropriate image order entry and by alerting providers to the results of prior, potentially relevant imaging procedures, thereby reducing redundant imaging. The American Recovery and Reinvestment Act (ARRA) has expedited the adoption of computerized physician order entry and CDS systems in health care through the creation of financial incentives and penalties to promote the "meaningful use" of health IT. Meaningful use represents the latest logical next step in a long chain of legislation promoting the areas of appropriate imaging utilization, accurate reporting, and IT. It is uncertain if large-scale implementation of imaging CDS will lead to improved health care quality, as seen in smaller settings, or to improved patient outcomes. However, imaging CDS enables the correlation of existing imaging evidence with outcome measures, including morbidity, mortality, and short-term imaging-relevant management outcomes (eg, biopsy, chemotherapy). The purposes of this article are to review the legislative sequence relevant to imaging CDS and to give guidance to radiology practices focused on quality and financial performance improvement during this time of accelerating regulatory change.