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Abstract Background The anti-fibrotic medications nintedanib and pirfenidone were approved in the United States for use in patients with idiopathic pulmonary fibrosis several years ago. While there is a growing body of evidence surrounding their clinical effectiveness, these medications are quite expensive and no prior cost-effectiveness analysis has been performed in the United States. Methods A previously published Markov model performed in the United Kingdom was replicated using United States data to project the lifetime costs and health benefits of treating idiopathic pulmonary fibrosis with: (1) symptom management; (2) pirfenidone; or (3) nintedanib. For the cost-effectiveness analysis, strategies were ranked by increasing costs and then checked for dominating treatment strategies. Then an incremental cost-effectiveness ratio was calculated for the dominant therapy. Results The anti-fibrotic medications were found to cost more than $110,000 per year compared to $12,291 annually for symptom management. While pirfenidone was slightly more expensive than nintedanib and provided the same amount of benefit, neither medication was found to be cost-effective in this U.S.-based analysis, with an average cost of $1.6 million to gain one additional quality-adjusted life year over symptom management. Conclusions Though the anti-fibrotics remain the only effective treatment option for patients with idiopathic pulmonary fibrosis and the data surrounding their clinical effectiveness continues to grow, they are not considered cost-effective treatment strategies in the United States due to their high price.

Abstract Background Transitioning care from hospital to home is associated with risks of adverse events and poor continuity of care. These transitions are even more challenging when new approaches to care, such as palliative care, are introduced before discharge. Family caregivers (FCGs) are expected to navigate these transitions while also managing care. In addition to extensive caregiving responsibilities, FCGs often have their own health needs that can inhibit their ability to provide care. Those living in rural areas have even fewer resources to meet their self-care and caregiving needs. The purpose of this study is to test the efficacy and cost-effectiveness of an intervention to improve FCGs’ health and well-being. The intervention uses video visits to teach, guide, and counsel FCGs in rural areas during hospital-to-home transitions. The intervention is based on evidence of transitional and palliative care principles, which are individualized to improve continuity of care, provide caregiver support, enhance knowledge and skills, and attend to caregivers’ health needs. It aims to test whether usual care practices are similar to this technology-enhanced intervention in (1) caregiving skills (e.g., caregiving preparedness, communication with clinicians, and satisfaction with care), (2) FCG health outcomes (e.g., quality of life, burden, coping skills, depression), and (3) cost. We describe the rationale for targeting rural caregivers, the methods for the study and intervention, and the analysis plan to test the intervention’s effect. Methods The study uses a randomized controlled trial design, with FCGs assigned to the control condition or the caregiver intervention by computer-generated lists. The intervention period continues for 8 weeks after care recipients are discharged from the hospital. Data are collected at baseline, 2 weeks, 8 weeks, and 6 months. Time and monetary costs from a societal perspective are captured monthly. Discussion This study addresses 2 independent yet interrelated health care foci—transitional care and palliative care—by testing an intervention to extend palliative care practice and improve transition management for caregivers of seriously ill patients in rural areas. The comprehensive cost assessment will quantify the commitment and financial burden of FCGs. Trial registration ClinicalTrials.gov NCT03339271 . Registered on 13 November 2017. Protocol version: 11.

Abstract Background The potential economic benefit in terms of reduced healthcare costs when patients quit smoking after hospital discharge has not been directly measured. The aim of this study was to compare the costs for hospital admission and six-month follow-up for a cohort of patients who self-reported abstinence from cigarettes at 6 months after hospital discharge and a matched group of patients who reported continued smoking. Materials and methods This was a secondary analysis of a recent population-based clinical trial cohort (ClinicalTrials.gov ID: NCT01575145), with cohort membership determined by self-reported 7 day point prevalence abstinence at 6 months after the index hospital discharge. Participants were admitted to Mayo Clinic Hospital, Rochester, MN, between May 5, 2012 and August 10, 2014 for any indication and lived in the areas covered by postal codes included in Olmsted County, MN. Propensity score matching was used to control for differences between groups other than smoking status, and any residual imbalance was adjusted through generalized linear model with gamma distribution for cost and log-link transformation. Results Of 600 patients enrolled in the clinical trial, 144 could be contacted and self-reported 7 day point prevalence abstinence at 6 months after hospital discharge. Of these patients, 99 were successfully matched for this analysis. The cost for the index hospitalization was significantly greater in patients who abstained compared to those that did not abstain (mean difference of $3042, higher for abstainers, 95% CI $170 to $5913, P = 0.038). However, there was no difference between mean 6-month follow-up costs, number of inpatient hospitalizations, or number of emergency room visits for abstainers versus non-abstainers. Conclusion There was no evidence to support the hypothesis that abstinence at 6 months after hospital discharge is associated with a decrease in health care costs or utilization over the first 6 months after hospital discharge.

Abstract Background Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible approach within LCS programs. Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals. Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment. Methods This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) program and integrated text messaging (TXT) in a three-arm randomized trial with repeated measures at one, three, six, and 12 months post randomization. The primary outcome is biochemically confirmed abstinence at 12 months post randomization. We will randomize 1650 smokers who present for a clinical LCS to: (1) a usual care control condition (UC) which consists of Ask–Advise–Refer; (2) a digital (WEB + TXT) cessation intervention; or (3) a digital cessation intervention combined with tobacco treatment specialist (TTS) counseling (WEB + TXT + TTS). Discussion The scalability and sustainability of a digital intervention may represent the most cost-effective and feasible approach for LCS programs to proactively engage large numbers of smokers in effective cessation treatment. We will also evaluate the impact and cost-effectiveness of adding proven clinical intervention provided by a TTS. We expect that a combined digital/clinical intervention will yield higher quit rates than digital alone, but that it may not be as cost-effective or feasible for LCS programs to implement. This study is innovative in its use of interoperable, digital technologies to deliver a sustainable, scalable, high-impact cessation intervention and to facilitate its integration within clinical practice. It will add to the growing knowledge base about the overall effectiveness of digital interventions and their role in the healthcare delivery system. Trial registration ClinicalTrials.gov, NCT03084835 . Registered on 9 March 2017.

Abstract Background Research addressing value in healthcare requires a measure of cost. While there are many sources and types of cost data, each has strengths and weaknesses. Many researchers appear to create study-specific cost datasets, but the explanations of their costing methodologies are not always clear, causing their results to be difficult to interpret. Our solution, described in this paper, was to use widely accepted costing methodologies to create a service-level, standardized healthcare cost data warehouse from an institutional perspective that includes all professional and hospital-billed services for our patients. Methods The warehouse is based on a National Institutes of Research–funded research infrastructure containing the linked health records and medical care administrative data of two healthcare providers and their affiliated hospitals. Since all patients are identified in the data warehouse, their costs can be linked to other systems and databases, such as electronic health records, tumor registries, and disease or treatment registries. Results We describe the two institutions’ administrative source data; the reference files, which include Medicare fee schedules and cost reports; the process of creating standardized costs; and the warehouse structure. The costing algorithm can create inflation-adjusted standardized costs at the service line level for defined study cohorts on request. Conclusion The resulting standardized costs contained in the data warehouse can be used to create detailed, bottom-up analyses of professional and facility costs of procedures, medical conditions, and patient care cycles without revealing business-sensitive information. After its creation, a standardized cost data warehouse is relatively easy to maintain and can be expanded to include data from other providers. Individual investigators who may not have sufficient knowledge about administrative data do not have to try to create their own standardized costs on a project-by-project basis because our data warehouse generates standardized costs for defined cohorts upon request.

Abstract Background Although inverse associations have been found between medication adherence and healthcare use and spending outcomes in many clinical settings, no studies to date have examined these relationships for patients with idiopathic pulmonary fibrosis (IPF) initiating nintedanib. We build on our prior study that used group-based trajectory modeling (GBTM) to compare inpatient hospitalization and medical care spending outcomes between groups of patients with different nintedanib adherence trajectories. Methods This analysis used 100% Medicare data and included beneficiaries with IPF who initiated nintedanib during 10/01/2014–12/31/2018. The sample consisted of community-dwelling older adults (≥ 66 years) with continuous coverage in Medicare Parts A (inpatient care), B (outpatient care) and D (prescription drugs) for one year before (baseline) and after (follow-up) initiating nintedanib. Patients were assigned to the GBTM-derived adherence trajectory group closest to their own nintedanib adherence experience. All-cause and IPF-related hospitalization events and total medical spending were measured during the follow-up period. Unadjusted and adjusted regression models were estimated to compare outcomes between patients in different nintedanib adherence trajectories. Results Among the 1,798 patients initiating nintedanib, the mean age was 75.4 years, 61.1% were male, and 91.1% were non-Hispanic white. The best-fitting GBTM had five adherence trajectories: high adherence, moderate adherence, high-then-poor adherence, delayed-poor adherence, and early-poor adherence. All-cause hospitalizations and total all-cause medical spending were higher among patients in the high-then-poor, delayed-poor and early-poor adherence trajectories than those in the high adherence trajectory. For example, adjusted total all-cause medical spending was $4,876 (95% CI: $1,470 to $8,282) higher in the high-then-poor adherence trajectory, $3,639 (95% CI: $1,322 to $5,955) higher in the delayed-poor adherence trajectory and $3,907 (95% CI: $1,658 to $6,156) higher in the early-poor adherence trajectory compared with the high adherence trajectory. IPF-related hospitalizations and medical care spending were higher among those in the high-then-poor adherence trajectory compared with those in the high adherence trajectory. Conclusions Poor adherence to nintedanib was associated with all-cause hospitalizations and medical costs. Therefore, improved adherence programs, such as support programs, can be implemented to reduce economic burden.