Amputation Rates for Patients with Diabetes and Peripheral Arterial Disease: The Effects of Race and Region.

BACKGROUND: It remains unknown whether care of high-risk vascular patients with both diabetes and peripheral arterial disease (PAD) is improving. We examined national trends in care of patients with both PAD and diabetes. METHODS: A cohort of patients diagnosed with PAD and diabetes between 2007 and 2011 undergoing open or endovascular diagnostic or revascularization procedures was analyzed using Medicare claims data. Main outcome measure was amputation-free survival measured from time of initial revascularization procedure to 24 months, stratified by race and hospital referral region (HRR). RESULTS: From 2007 to 2011, 2.3 per 1,000 patients underwent a major amputation with the higher rate among black patients (5.5 per 1,000 vs. 1.9 per 1,000; P < 0.001) compared with nonblack. The rate varied widely by HRR (1.2 per 1,000-6.2 per 1,000), with higher variation in amputation rates in black patients (2.1-16.1 per 1,000). Overall, amputation-free survival was approximately 74.6% at 2 years, 68.4% among black patients, and 75.4% among nonblack patients, with the disparity between the 2 groups increasing over time. CONCLUSIONS: Prevalence of concurrent PAD and diabetes is increasing, but amputation rates and amputation-free survival vary significantly by both race and HRR. Prevention and care coordination effort should aim to limit racial disparities in the treatment and outcomes of these high-risk patients.

Expanding Cessation Pharmacotherapy Via Videoconference Educational Outreach to Prescribers.

INTRODUCTION: Smoking cessation pharmacotherapy is underutilized by people with mental illnesses, who smoke at high rates and die prematurely of smoking-related diseases. Educational outreach can improve prescribing, but distances impede widespread use of this practice. Little research has assessed whether videoconference can effectively deliver educational outreach. We conducted a randomized, controlled trial of in-person versus videoconference educational outreach for smoking cessation pharmacotherapy across a state mental health system. METHODS: We randomly assigned clinics to receive in-person or videoconference educational outreach with audit and feedback for cessation pharmacotherapy. Prescribers completed brief questionnaires before and after the intervention. With segmented regression analysis of interrupted time series, we evaluated prescribing trends in Medicaid pharmacy claims for nicotine replacement therapy (NRT) and varenicline, with interaction terms for the effect of intervention type (in-person vs. videoconference). RESULTS: With interaction terms in the model, filled NRT prescriptions increased after the intervention compared to before (p < .01). The pattern of fills after the intervention were different at centers receiving in-person compared to videoconference educational outreach (p < .02) without clearly favoring one over the other. Additionally, filled varenicline prescriptions increased after the intervention compared to before (p = .04), but type of intervention delivery did not influence varenicline fills. Prescriber satisfaction with the educational intervention was high and prescriber attitudes became more positive in both groups. CONCLUSION: This study suggests that single session educational outreach with audit and feedback can increase cessation pharmacotherapy utilization, and that videoconference delivery could be an effective, scalable approach to improve workforce capacity in systems serving mentally ill smokers.

The interaction among donor characteristics, severity of liver disease, and the cost of liver transplantation.

Accurate assessment of the impact of donor quality on liver transplant (LT) costs has been limited by the lack of a large, multicenter study of detailed clinical and economic data. A novel, retrospective database linking information from the University HealthSystem Consortium and the Organ Procurement and Transplantation Network registry was analyzed using multivariate regression to determine the relationship between donor quality (assessed through the Donor Risk Index [DRI]), recipient illness severity, and total inpatient costs (transplant and all readmissions) for 1 year following LT. Cost data were available for 9059 LT recipients. Increasing MELD score, higher DRI, simultaneous liver-kidney transplant, female sex, and prior liver transplant were associated with increasing cost of LT (P < 0.05). MELD and DRI interact to synergistically increase the cost of LT (P < 0.05). Donors in the highest DRI quartile added close to $12,000 to the cost of transplantation and nearly $22,000 to posttransplant costs in comparison to the lowest risk donors. Among the individual components of the DRI, donation after cardiac death (increased costs by $20,769 versus brain dead donors) had the greatest impact on transplant costs. Overall, 1-year costs were increased in older donors, minority donors, nationally shared organs, and those with cold ischemic times of 7-13 hours (P < 0.05 for all). In conclusion, donor quality, as measured by the DRI, is an independent predictor of LT costs in the perioperative and postoperative periods. Centers in highly competitive regions that perform transplantation on higher MELD patients with high DRI livers may be particularly affected by the synergistic impact of these factors.

Liver transplantation cost in the model for end-stage liver disease era: looking beyond the transplant admission.

We examined the relationship between the total cost incurred by liver transplantation (LT) recipients and their Model for End-Stage Liver Disease (MELD) score at the time of transplant. We used a novel database linking billing claims from a large private payer with the Organ Procurement and Transplantation Network registry. Included were adults who underwent LT from March 2002 through August 2007 (n = 990). Claims within the year preceding and following transplantation were analyzed according to the recipient's calculated MELD score. Cost was the primary endpoint and was assessed by the length of stay and charges. Transplant admission charges represented approximately 50% of the total cost of LT. MELD was a significant cost driver for pretransplant, transplant, and total charges. A MELD score of 28 to 40 was associated with additional charges of $349,213 (P < 0.05) in comparison with a score of 15 to 20. Pretransplant and transplant admission charges were higher by $152,819 (P < 0.05) and $64,286 (P < 0.05), respectively, in this higher MELD group. No differences by MELD score were found for posttransplant charges. Those in the highest MELD group also experienced longer hospital stays both in the pretransplant period and at the time of LT but did not have higher rates of re-admissions. In conclusion, high-MELD patients incur significantly higher costs prior to and at the time of LT. Following LT, the MELD score is not a significant predictor of cost or re-admission.

Use of Academic Detailing With Audit and Feedback to Improve Antipsychotic Pharmacotherapy.

OBJECTIVE: Second-generation antipsychotics vary in their propensity to cause serious cardiometabolic side effects. In addition, use of two or more antipsychotics (polypharmacy) may lead to additive side effects and has not been shown to be consistently more effective than monotherapy. This study examined the use of academic detailing with audit and feedback to improve antipsychotic prescribing practices, including antipsychotic polypharmacy and utilization of medication with high or low risk of cardiometabolic side effects ("high risk" or "low risk," respectively). METHODS: Four intervention sessions were provided over two years to psychiatric care providers at community mental health centers. Segmented regression within the general estimating equation model framework used Medicaid pharmacy claims to examine prescribing patterns before and after the intervention among all beneficiaries (67,721 person-months) over a five-year period. RESULTS: After the intervention, 10.9% of beneficiaries with antipsychotic claims were on polypharmacy, compared with 13.1% before the invention. Use of high-risk and low-risk antipsychotics did not change. The final adjusted polypharmacy model showed that antipsychotic polypharmacy decreased among young adults and adults ages 40 or older compared with beneficiaries ages 30-39 (ß=-.02, p=.04, and ß=-.02, p=.007, respectively). The raw proportion of beneficiaries on high- and low-risk agents did not change, although final adjusted models demonstrated changes in use of high- and low-risk agents by diagnosis and risk group. CONCLUSIONS: Polypharmacy decreased among young and older adults after academic detailing with audit and feedback. Although further research is needed, this low-intensity intervention may help mental health systems reduce antipsychotic polypharmacy.

Clopidogrel use as a risk factor for poor outcomes after kidney transplantation.

BACKGROUND: Limited data are available on outcome implications of clopidogrel use before kidney transplantation. METHODS: A novel dataset linking national transplant registry data with records from a large pharmacy claims clearinghouse (2005 to 2010) was examined to estimate risks of post-transplant death and graft failure associated with clopidogrel fills within 90 or more than 90 days before transplant. RESULTS: Clopidogrel fills within 90 days of transplant were associated with 61% of increased relative mortality risk and 23% of increased graft failure risk. Risks were higher in those whose last clopidogrel fill was more than 90 days before transplantation (111% for death, 59% for graft loss). Adverse prognostic associations persisted among recipients of live and deceased donor allografts, older recipients, and those with diabetes or reported cardiovascular disease. CONCLUSIONS: Clopidogrel use before kidney transplantation portends increased risks of post-transplant death and graft loss. Pharmacy claims may identify novel prognostic markers not currently captured in the transplant registry.

Prognostic impact of mechanical ventilation after liver transplantation: a national database study.

BACKGROUND: The impact of mechanical ventilatory support (MCVS) on mortality and graft loss after liver transplantation (LT) is not well described. METHODS: Multivariate analysis of a novel database linking national transplant registry and Medicare claims data was used to assess the impact of early MCVS on mortality and graft survival following LTs performed between 2002 and 2008. RESULTS: Among 10,517 LT recipients, 6.9% (n = 726) required postoperative MCVS, 25.6% of whom required less than 96 hours, 24.2% required 96 hours or longer, and 50.1% received an unspecified duration. Significant predictors of prolonged MCVS included older age, female sex, pretransplant dialysis requirement, and ascites. After multivariate adjustment, MCVS of 96 hours or longer was associated with nearly 3 times the adjusted hazard ratio of mortality (2.95, P < .001), while MCVS less than 96 hours was not significantly associated with mortality (adjusted hazard ratio .88, P = .55). CONCLUSIONS: Recognition of LT patients at risk for prolonged MCVS may help to reduce the incidence and consequences of this complication.

Clinical correlates, outcomes and healthcare costs associated with early mechanical ventilation after kidney transplantation.

BACKGROUND: Information is lacking on the frequency, clinical implications, and costs of respiratory failure requiring mechanical ventilation after kidney transplantation. METHODS: U.S. Renal Data System records for Medicare-insured kidney transplant recipients (1995 to 2007; n = 88,392) were examined to identify post-transplantation mechanical ventilation from billing claims within 30 days after transplantation. RESULTS: Post-transplantation mechanical ventilation was required among 2.1% of the cohort. Independent correlates of early mechanical ventilation included recipient age, low body mass index, coronary artery disease, and cerebrovascular disease. Post-transplantation mechanical ventilation was twice as likely with delayed graft function (adjusted odds ratio, 2.13; P < .001) and 35% lower among recipients of living versus deceased donor allografts. Patients needing early mechanical ventilation experienced 5-fold higher 1-year mortality, as well as significantly higher Medicare costs during the transplant hospitalization and first post-transplantation year. CONCLUSIONS: Recognition of patients at risk for post-transplantation respiratory failure may help direct protocols for reducing the incidence and consequences of this complication.

Following the organ supply: assessing the benefit of inter-DSA travel in liver transplantation.

BACKGROUND: Disparity in access to liver transplantation (LT) in the United States persists despite directives from the federal government to reduce geographic variation. We assessed the impact of socioeconomic status (SES) and traveling to alternative donation service areas (DSAs) on patient survival. METHODS: A prospective cohort study integrating transplant registry and U.S. Census data was analyzed using multivariate linear Cox proportional hazards models. A separate matched-pairs analysis was used to assess the benefit of traveling on patient survival and transplantation rate. RESULTS: High SES is associated with increased access to LT (adjusted hazard ratio [aHR], 1.05; 95% confidence interval [95% CI], 1.01-1.08) and reduced mortality after waitlisting (aHR [95% CI], 0.88 [0.85-0.93]). Increased access is mediated, in part, through inter-DSA travel. Travel was associated with high SES, white race, blood group O, private insurance, and residence in regions 1, 5, and 11. Transplant candidates in the highest SES quartile were approximately 70% more likely to travel (aHR [95% CI], 1.67 [1.43-1.97]) than those in the lowest SES quartile. Compared with matched control patients, travelers were 74% more likely to be transplanted (aHR [95% CI], 1.74 [1.56-1.94]) and 20% less likely to die after listing (aHR [95% CI], 0.79 [0.69-0.92]). CONCLUSION: High SES and inter-DSA travel are strongly associated with increased LT access and reduced mortality. Travelers are more likely to be sociodemographically advantaged and privately insured and to live in regions with reduced access to deceased-donor organs.

The interplay of socioeconomic status, distance to center, and interdonor service area travel on kidney transplant access and outcomes.

BACKGROUND AND OBJECTIVES: Variation in kidney transplant access across the United States may motivate relocation of patients with ability to travel to better-supplied areas. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We examined national transplant registry and U.S. Census data for kidney transplant candidates listed in 1999 to 2009 with a reported residential zip code (n = 203,267). Cox's regression was used to assess associations of socioeconomic status (SES), distance from residence to transplant center, and relocation to a different donation service area (DSA) with transplant access and outcomes. RESULTS: Patients in the highest SES quartile had increased access to transplant compared with those with lowest SES, driven strongly by 76% higher likelihood of living donor transplantation (adjusted hazard ratio [aHR] 1.76, 95% confidence interval [CI] 1.70 to 1.83). Waitlist death was reduced in high compared with low SES candidates (aHR 0.86, 95% CI 0.84 to 0.89). High SES patients also experienced lower mortality after living and deceased donor transplant. Patients living farther from the transplant center had reduced access to deceased donor transplant and increased risk of post-transplant death. Inter-DSA travel was associated with a dramatic increase in deceased donor transplant access (HR 1.94, 95% CI 1.88 to 2.00) and was predicted by high SES, white race, and longer deceased-donor allograft waiting time in initial DSA. CONCLUSIONS: Ongoing disparities exist in kidney transplantation access and outcomes on the basis of geography and SES despite near-universal insurance coverage under Medicare. Inter-DSA travel improves access and is more common among high SES candidates.

Incremental value of the pancreas allograft to the survival of simultaneous pancreas-kidney transplant recipients.

OBJECTIVE: To quantify the incremental survival benefit of the pancreas allograft in simultaneous pancreas-kidney (SPK) transplant recipients. RESEARCH DESIGN AND METHODS: Data from the national transplant database from 2000 to 2007 were analyzed. SPK recipients who had functioning allografts to 1-year post transplant (n = 3,304) were compared with those who had failure of the renal (n = 233) or pancreatic (n = 112) graft. The main outcome was a projection of 10 life-years of patient survival beyond the first transplant anniversary. RESULTS: Recipients with function of both organs accrued 9.4 life-years following transplantation. Projected survival in patients with kidney failure was reduced to 2.5 life-years. Pancreas failure reduced predicted survival to 8 life-years. Renal allograft failure impacts life expectancy significantly (adjusted hazard ratio [aHR] 12.13). However, pancreas allograft failure was also associated with reduced survival (aHR 2.62). CONCLUSIONS: Although the majority of the survival benefit of SPK transplant is due to the renal transplant, pancreas allograft function does contribute to patient survival.

Early outcomes of thymoglobulin and basiliximab induction in kidney transplantation: application of statistical approaches to reduce bias in observational comparisons.

BACKGROUND: Retrospective comparison of treatment-related kidney transplant outcomes may be facilitated by multivariable statistical adjustments and case-matching. METHODS: We studied Organ Procurement and Transplantation Network registry data for kidney transplants in 2001 to 2005 managed with thymoglobulin, basiliximab, or no antibody induction and discharge maintenance immunosuppression regimens of tacrolimus and mycophenolate mofetil. The primary outcome was the 6 month, Food and Drug Administration-approved composite endpoint of rejection, graft failure, or death. Outcomes according to induction exposure were compared using logistic regression analysis, exposure likelihood matching, and outcome risk score matching. RESULTS: All statistical approaches demonstrated lower rates of the 6-month triple endpoint with thymoglobulin compared with basiliximab when steroids were present, with approximately 22% adjusted, relative reduction by logistic regression analysis and 3% absolute reductions by matching approaches. When steroids were absent, risk reduction among thymoglobulin versus basiliximab-treated patients was of larger magnitude but borderline statistical significance. Triple endpoint incidence was lower with both induction regimens compared with no induction across methods. Estimated sample sizes necessary to detect the observed differences between induction types in the presence of steroids in a prospective trial ranged from 1600 to nearly 7000 patients. CONCLUSIONS: Consistency across statistical approaches suggests superiority of thymoglobulin compared with basiliximab or no antibody induction therapy for 6-month kidney transplant outcomes in the modern immunosuppression era. As the sample sizes necessary to power a prospective superiority trial are likely prohibitive, studies such as these provide clinically relevant information that may not be otherwise attainable.

Novel methods for tracking long-term maintenance immunosuppression regimens.

BACKGROUND AND OBJECTIVES: Accurate assessment of the use of immunosuppressive medications is vital for observational analyses that are widely used in transplantation research. This study assessed the accuracy of three potential sources of maintenance immunosuppression data. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This study investigated the agreement of immunosuppression information in directly linked electronic medical records for Medicare beneficiaries who received a kidney transplant at one center in 1998 through 2001, Organ Procurement and Transplantation Network (OPTN) survey data, and Medicare pharmacy claims. Pair-wise, interdata concordance (kappa) and percentage agreement statistics were used to compare immunosuppression regimens reported at discharge, and at 6 mo and 1 yr after transplantation in each data source. RESULTS: Among 181 eligible participants, agreement between data sources for nonsteroid immunosuppression increased with time after transplantation. By 1-yr, concordance was excellent for calcineurin inhibitors and mycophenolate mofetil (kappa = 0.79 to 1.00), and very good for azathioprine (kappa = 0.73 to 0.85). Similarly, percentage agreement at 1 yr was 94.9 to 100% for calcineurin inhibitors, 91.1 to 95.7% for mycophenolate mofetil, and 87.5 to 92.8% for azathioprine. Widening the comparison time window resolved 33.6% of cases with discordant indications of calcineurin inhibitor and/or antimetabolite use in claims compared with other data sources. CONCLUSIONS: This analysis supports the accuracy of the three sources of data for description of nonsteroid immunosuppression after kidney transplantation. Given the current strategic focus on reducing collection of data, use of alternative measures of immunosuppression exposure is appropriate and will assume greater importance.