Geographic Variation in Informed Consent Law: Two Standards for Disclosure of Treatment Risks

We analyzed 714 jury verdicts in informed consent cases tried in 25 states in 1985–2002 to determine whether the applicable standard of care (“patient” vs. “professional” standard) affected the outcome. Verdicts for plaintiffs were significantly more frequent in states with a patient standard than in states with a professional standard (27 percent vs. 17 percent, P = 0.02). This difference in outcomes did not hold for other types of medical malpractice litigation (36 percent vs. 37 percent, P = 0.8). The multivariate odds of a plaintiff’s verdict were more than twice as high in states with a patient standard than in states with a professional standard (odds ratio = 2.15, 95% confidence interval = 1.32–3.50). The law’s expectations of clinicians with respect to risk disclosure appear to vary geographically

Year 1 of the Bundled Payments for Care Improvement-Advanced model

BACKGROUND: The Center for Medicare and Medicaid Innovation launched the Medicare Bundled Payments for Care Improvement-Advanced (BPCI-A) program for hospitals in October 2018. Information is needed about the effects of the program on health care utilization and Medicare payments. METHODS: We conducted a modified segmented regression analysis using Medicare claims and including patients with discharge dates from January 2017 through September 2019 to assess differences between BPCI-A participants and two control groups: hospitals that never joined the BPCI-A program (nonjoining hospitals) and hospitals that joined the BPCI-A program in January 2020, after the conclusion of the intervention period (late-joining hospitals). The primary outcomes were the differences in changes in quarterly trends in 90-day per-episode Medicare payments and the percentage of patients with readmission within 90 days after discharge. Secondary outcomes were mortality, volume, and case mix. RESULTS: A total of 826 BPCI-A participant hospitals were compared with 2016 nonjoining hospitals and 334 late-joining hospitals. Among BPCI-A hospitals, the mean baseline 90-day per-episode Medicare payment was $27,315; the change in the quarterly trends in the intervention period as compared with baseline was -$78 per quarter. Among nonjoining hospitals, the mean baseline 90-day per-episode Medicare payment was $25,994; the change in quarterly trends as compared with baseline was -$26 per quarter (difference between nonjoining hospitals and BPCI-A hospitals, $52 [95$26,807; the change in the quarterly trends as compared with baseline was $4 per quarter (difference between late-joining hospitals and BPCI-A hospitals,$82 [95% CI, 41 to 122] per quarter; P\u3c0.001; 0.3% of the baseline payment). There were no meaningful differences in the changes with regard to readmission, mortality, volume, or case mix. CONCLUSIONS: The BPCI-A program was associated with small reductions in Medicare payments among participating hospitals as compared with control hospitals. (Funded by the National Heart, Lung, and Blood Institute.)

Association of physician group practice participation in bundled payments with patient selection, costs, and outcomes for joint replacement

IMPORTANCE: Medicare\u27s Bundled Payments for Care Improvement (BPCI) program, which ran from 2013 to 2018, was an important experiment in physician-focused alternative payment models. However, little is known about whether the program was associated with better quality or outcomes or lower costs. OBJECTIVE: To determine whether participation in BPCI among physician group practices was associated with advantageous or deleterious changes in costs or patient outcomes. DESIGN SETTING AND PARTICIPANTS: This cross-sectional study used 2013 to 2017 Medicare files and difference-in-differences (DID) models to compare the change over time in Medicare payments, patient selection, and clinical outcomes between 91 orthopedic groups in BPCI Model 2 and 169 propensity-matched controls for patients undergoing joint replacement. Analyses were performed between December 2019 and February 2021. EXPOSURES: Voluntary participation in BPCI. MAIN OUTCOMES AND MEASURES: The primary outcome was 90-day Medicare payments; secondary outcomes were patient selection (volume, comorbidities) and clinical outcomes (30-day and 90-day emergency department visits, readmissions, mortality, and healthy days at home). RESULTS: There were 74 343 patient episodes in the baseline period and 102 790 during the intervention in BPCI practices, and 88 147 patient episodes in the baseline period and 120 253 during the intervention in control practices; 291 214 of 461 598 (63.1%) patients were women, and 419 619 (90.9%) were White. At baseline, mean episode payments among BPCI-participating practices were $18 257, which decreased to$15 320 during the intervention, while control practices decreased from $17 927 to$16 170 (DID, -$1180; 95$1565 to -$795; CONCLUSIONS AND RELEVANCE: Group practice participation in BPCI for joint replacement was associated with reduced Medicare payments and improvements in clinical outcomes

Changes in racial equity associated with participation in the Bundled Payments for Care Improvement Advanced Program

IMPORTANCE: The Medicare alternative payment models are designed to incentivize cost reduction and quality improvement, but there are no requirements established for evaluating the outcomes of the Medicare populations. OBJECTIVE: To examine whether participation in the Medicare Bundled Payments for Care Improvement Advanced (BPCI-A) program was associated with narrowing or widening of Black and White racial inequities in outcomes and access. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort alternative payment models on equity and quality for disadvantaged populations were studied between April 6, 2021, and August 28, 2022, in US hospitals. Black and White Medicare beneficiaries admitted for any of the 29 inpatient conditions in the BPCI-A program between January 1, 2017, and September 31, 2019, were included. EXPOSURES: BPCI-A participation implemented in 2018. MAIN OUTCOMES AND MEASURES: Ninety-day readmission and mortality, healthy days at home, and proportion of Black patients hospitalized. Segmented regression models were used to examine quarterly changes in slopes for each outcome. RESULTS: The sample included 6 690 336 episodes (6 019 359 White patients, 670 977 Black patients). The population comprised approximately 43% men, 57% women, 17% individuals younger than 65 years, 47% between ages 65 and 80 years, and 36% older than 80 years. Prior to implementation of the BPCI-A program, compared with episodes for White patients, Black patients had higher 90-day readmissions (36.3% vs 29.6%), similar 90-day mortality (12.3% vs 13.3%), and fewer healthy days at home (mean, 68.5 vs 69.5 days). BPCI-A participation was not associated with significant changes in the racial gap in readmissions but was associated with a greater gain in heathy days at home (differences by race, -0.07 days per quarter; 95% CI, -0.12 to -0.01 days per quarter). Among Black patients admitted to BPCI-A hospitals vs controls, healthy days at home increased by 0.09 more days/episode per quarter (95% CI, 0.02-0.17 days/episode per quarter). The proportion of Black patients decreased similarly at BPCI-A and control hospitals. CONCLUSIONS AND RELEVANCE: In this cohort study, BPCI-A participation was not associated with improvements in racial inequities in clinical outcomes. Black patients in BPCI-A had a slight gain in healthy days at home; there were no changes in access. The findings of this study suggest that more needs to be done if payment policy reform is going to be part of the efforts to address glaring racial inequities in health care quality and outcomes. These findings support a need for payment policy reform specifically targeting equity-enhancing programs

Changes in cardiovascular spending, care utilization, and clinical outcomes associated with participation in bundled payments for care improvement - Advanced

BACKGROUND: Bundled Payments for Care Improvement - Advanced (BPCI-A) is a Medicare initiative that aims to incentivize reductions in spending for episodes of care that start with a hospitalization and end 90 days after discharge. Cardiovascular disease, an important driver of Medicare spending, is one of the areas of focus BPCI-A. It is unknown whether BPCI-A is associated with spending reductions or quality improvements for the 3 cardiovascular medical events or 5 cardiovascular procedures in the model. METHODS: In this retrospective cohort study, we conducted difference-in-differences analyses using Medicare claims for patients discharged between January 1, 2017, and September 30, 2019, to assess differences between BPCI-A hospitals and matched nonparticipating control hospitals. Our primary outcomes were the differential changes in spending, before versus after implementation of BPCI-A, for cardiac medical and procedural conditions at BPCI-A hospitals compared with controls. Secondary outcomes included changes in patient complexity, care utilization, healthy days at home, readmissions, and mortality. RESULTS: Baseline spending for cardiac medical episodes at BPCI-A hospitals was $25 606. The differential change in spending for cardiac medical episodes at BPCI-A versus control hospitals was$16 (95% CI, -$228 to$261; CONCLUSIONS: Participation in BPCI-A was not associated with spending reductions, changes in care utilization, or quality improvements for the cardiovascular medical events or procedures offered in the model

Valsartan for attenuating disease evolution in early sarcomeric hypertrophic cardiomyopathy: the design of the Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy (VANISH) trial

Background: Hypertrophic cardiomyopathy (HCM) is often caused by sarcomere gene mutations, resulting in left ventricular hypertrophy (LVH), myocardial fibrosis, and increased risk of sudden cardiac death and heart failure. Studies in mouse models of sarcomeric HCM demonstrated that early treatment with an angiotensin receptor blocker (ARB) reduced development of LVH and fibrosis. In contrast, prior human studies using ARBs for HCM have targeted heterogeneous adult cohorts with well-established disease. The VANISH trial is testing the safety and feasibility of disease-modifying therapy with an ARB in genotyped HCM patients with early disease. Methods: A randomized, placebo-controlled, double-blind clinical trial is being conducted in sarcomere mutation carriers, 8 to 45 years old, with HCM and no/minimal symptoms, or those with early phenotypic manifestations but no LVH. Participants are randomly assigned to receive valsartan 80 to 320 mg daily (depending on age and weight) or placebo. The primary endpoint is a composite of 9 z-scores in domains representing myocardial injury/hemodynamic stress, cardiac morphology, and function. Total z-scores reflecting change from baseline to final visits will be compared between treatment groups. Secondary endpoints will assess the impact of treatment on mutation carriers without LVH, and analyze the influence of age, sex, and genotype. Conclusions: The VANISH trial is testing a new strategy of disease modification for treating sarcomere mutation carriers with early HCM, and those at risk for its development. In addition, further insight into disease mechanisms, response to therapy, and phenotypic evolution will be gained

Effects of vitamin D, omega-3 fatty acids and a home exercise program on prevention of pre-frailty in older adults : The DO-HEALTH randomized clinical trial

Background The benefits of supplemental vitamin D3, marine omega-3 fatty acids, and a simple home exercise program (SHEP) on frailty prevention in generally healthy community-dwelling older adults are unclear. Objective To test the effect of vitamin D3, omega-3s, and a SHEP, alone or in combination on incident pre-frailty and frailty in robust older adults over a follow-up of 36 months. Methods DO-HEALTH is a multi-center, double-blind, placebo-controlled, 2x2x2 factorial randomized clinical trial among generally healthy European adults aged 70 years or older, who had no major health events in the 5 years prior to enrollment, sufficient mobility and intact cognitive function. As a secondary outcome of the DO-HEALTH trial, among the subset of participants who were robust at baseline, we tested the individual and combined benefits of supplemental 2,000 IU/day of vitamin D3, 1 g/day of marine omega-3s, and a SHEP on the odds of being pre-frail and frail over 3 years of follow-up. Results At baseline, 1,137 out of 2,157 participants were robust (mean age 74.3 years, 56.5% women, mean gait speed 1.18 m/s). Over a median follow-up time of 2.9 years, 696 (61.2%) became pre-frail and 29 (2.6%) frail. Odds ratios for becoming pre-frail were not significantly lower for vitamin D3, or omega 3-s, or SHEP, individually, compared to control (placebo for the supplements and control exercise). However, the three treatments combined showed significantly decreased odds (OR 0.61 [95% CI 0.38–0.98; p=0.04) of becoming pre-frail compared to control. None of the individual treatments or their combination significantly reduced the odds of becoming frail. Conclusion Robust, generally healthy and active older adults without major comorbidities, may benefit from a combination of high-dose, supplemental vitamin D3, marine omega-3s, and SHEP with regard to the risk of becoming pre-frail over 3 years

Design of MARQUIS2: study protocol for a mentored implementation study of an evidence-based toolkit to improve patient safety through medication reconciliation.

BackgroundThe first Multi-center Medication Reconciliation Quality Improvement Study (MARQUIS1) demonstrated that implementation of a medication reconciliation best practices toolkit decreased total unintentional medication discrepancies in five hospitals. We sought to implement the MARQUIS toolkit in more diverse hospitals, incorporating lessons learned from MARQUIS1.MethodsMARQUIS2 is a pragmatic, mentored implementation QI study which collected clinical and implementation outcomes. Sites implemented a revised toolkit, which included interventions from these domains: 1) best possible medication history (BPMH)-taking; 2) discharge medication reconciliation and patient/caregiver counseling; 3) identifying and defining clinician roles and responsibilities; 4) risk stratification; 5) health information technology improvements; 6) improved access to medication sources; 7) identification and correction of real-time discrepancies; and, 8) stakeholder engagement. Eight hospitalists mentored the sites via one site visit and monthly phone calls over the 18-month intervention period. Each site's local QI team assessed opportunities to improve, implemented at least one of the 17 toolkit components, and accessed a variety of resources (e.g. implementation manual, webinars, and workshops). Outcomes to be assessed will include unintentional medication discrepancies per patient.DiscussionA mentored multi-center medication reconciliation QI initiative using a best practices toolkit was successfully implemented across 18 medical centers. The 18 participating sites varied in size, teaching status, location, and electronic health record (EHR) platform. We introduce barriers to implementation and lessons learned from MARQUIS1, such as the importance of utilizing dedicated, trained medication history takers, simple EHR solutions, clarifying roles and responsibilities, and the input of patients and families when improving medication reconciliation