Veterans Health Administration response to 2021 recall of Philips Respironics devices: A case study.

This case study describes, for the time frame of June 2021 through August 2022, the U.S. Veterans Health Administration (VHA) organizational response to a manufacturer's recall of positive airway pressure devices used in the treatment of sleep disordered breathing. VHA estimated it could take over a year for Veterans to receive replacement devices. Veterans awaiting a replacement faced a dilemma. They could continue using the recalled devices and bear the product safety risks that led to the recall, or they could stop using them and bear the risks of untreated sleep disordered breathing. Using a program monitoring approach, we report on the processes VHA put in place to respond to the recall. Specifically, we report on the strategic, service, and operational plans associated with VHA's response to the recall for Veterans needing replacement devices. In program monitoring, the strategic plan reflects the internal process objectives for the program. The service plan articulates how the delivery of services will intersect the customer journey. The operational plan describes how the program's resources and actions must support the service delivery plan. VHA's strategic plan featured a clinician-led, as opposed to primarily legal or administrative response to the recall. The recall response team also engaged with VHA's medical ethics service to articulate an ethical framework guiding the allocation of replacement devices under conditions of scarcity. This framework proposed allocating scarce devices to Veterans according to their clinical need. The service plan invited Veterans to schedule visits with sleep providers who could assess their clinical need and counsel them accordingly. The operational plan distributed devices according to clinical need as they became available. Monitoring our program processes in real time helped VHA launch and adapt its response to a recall affecting more than 700,000 Veterans.

Associations between the Veterans Health Administration's Life-Sustaining Treatment Decisions Initiative and Quality of Care at the End of Life.

Background: In 2017, Veterans Health Administration (VHA) implemented the Life-Sustaining Treatment Decisions Initiative (LSTDI) to promote goals-of-care conversations (GoCC) between seriously ill patients and their practitioners, to document patient preferences in the electronic health record, and to provide care consistent with patients' goals. Objectives: We evaluated the associations between this initiative and quality of care in the last month of life (i.e., emergency department/intensive care unit [ED/ICU] visits and hospice consultations). Design: We conducted patient-level propensity score analyses to evaluate the associations between LSTDI and care utilization in the last 30 days of life. The primary exposure was a three-level factor: no GoCC (reference group), GoCC with Full Code, and GoCC with do not resuscitate (DNR). The outcomes were ED/ICU visits and hospice consultations within 30 days of death. Setting/Subjects: A total of 44,320 patients receiving care in Veterans (VA), who were older than 18, and who died and had a completed encounter within 24 months of death in a VA primary care, mental health, or medical specialty between January 2017 and December 2019. Results: Patients with a documented GoCC and DNR code status had decreased risk of ED visits (odds ratio [OR] = 0.6, 89% credible intervals [CI] = [0.57-0.64]) and ICU visits (OR = 0.49, 89% CI = [0.45-0.53]), and increased rates of hospice visits (ß = 2.18, 89% CI = [2.11-2.26]) compared with patients with no GoCC. Conclusion: The LSTDI had a positive impact by eliciting and documenting patient preferences for care at the end of life and quality of care in the last month of life. We observed associations between care preferences and ED/ICU visits and hospice consultations within 30 days of death. Further research should address the associations between LSTDI and use of palliative care, and outcomes associated with limits to specific life-sustaining treatments such as mechanical ventilation, artificial nutrition, and hydration.

Pediatric Discharge From the Emergency Department Against Medical Advice.

In this Ethics Rounds we present a conflict regarding discharge planning for a febrile infant in the emergency department. The physician believes discharge would be unsafe and would constitute a discharge against medical advice. The child's mother believes her son has been through an already extensive and painful evaluation and would prefer to monitor her well-appearing son closely at home with a safety plan and a next-day outpatient visit. Commentators assess this case from the perspective of best interest, harm-benefit, conflict management, and nondiscriminatory care principles and prioritize a high-quality informed consent process. They characterize the formalization of discharge against medical advice as problematic. Pediatricians, a pediatric resident, ethicists, an attorney, and mediator provide a range of perspectives to inform ethically justifiable options and conflict resolution practices.

Adverse Discharge Outcomes Associated With the Medicare Hospital Readmissions Reduction Program Among Commercially Insured Adults.

ABSTRACT: It is unknown if changes in the rate of discharges against medical advice (DAMA) are related to the implementation of the Medicare Hospital Readmissions Reduction Program (HRRP). We performed an interrupted time series analysis of monthly DAMA rates per 1,000 discharges of all enrolled individuals 18-64 years old with a hospitalization between January 1, 2006, and December 31, 2015, in a commercially insured population. We performed a segmented linear regression with two interruptions: (1) April 2010 to coincide with the passage of the HRRP and (2) October 2012 to coincide with the implementation of HRRP penalties. There were 1,087,812 discharges representing 668,823 individuals over 120 months. The downward trend in monthly DAMA rates was reversed significantly after April 2010 with a sustained 0.1 increase in the monthly rate that continued after the implementation of penalties in October 2012. Allowing for the two interruptions, there was a statistically significant positive trend (0.10; 0.06-0.13, p < .01) in April 2010. Relative to the first interruption, there was no statistically significant change in the slope in October 2012; the estimated slope was -0.04 (-0.08 to 0.002). Monthly DAMA rates increased in anticipation of and after HRRP implementation, suggesting a potential relationship between the HRRP and DAMA.

Discharges against medical advice and 30-day healthcare costs: an analysis of commercially insured adults.

Aim: Prior literature detailing the consequences of a discharge against medical advice (DAMA) has not focused on costs. We examine costs following a DAMA. Materials & methods: This retrospective cohort study utilized the IQVIA PharMetrics® Plus database to identify adults hospitalized during 2007-2015. We compared 30-day postdischarge healthcare costs between matched DAMA and routinely discharged groups. Results: Thirty-day healthcare costs for the DAMA group were US$1078 (95% CI: US$434-1730) higher, driven by inpatient readmissions (US$979; 95% CI: US$415-1543) and emergency department visits (US$79; 95% CI: US$56-102). Costs due to prescription drug fills were lower in the DAMA group. Conclusion: A DAMA was associated with higher 30-day postdischarge healthcare costs compared with routine discharges.

Between Usual and Crisis Phases of a Public Health Emergency: The Mediating Role of Contingency Measures.

Much of the sustained attention on pandemic preparedness has focused on the ethical justification for plans for the "crisis" phase of a surge when, despite augmentation efforts, the demand for life-saving resources outstrips supply. The ethical frameworks that should guide planning and implementation of the "contingency" phase of a public health emergency are less well described. The contingency phase is when strategies to augment staff, space, and supplies are systematically deployed to forestall critical resource scarcity, reduce disproportionate harm to patients and health care providers, and provide patient care that remains functionally equivalent to conventional practice. We describe an ethical framework to inform planning and implementation for COVID-19 contingency surge responses and apply this framework to 3 use cases. Examining the unique ethical challenges of this mediating phase will facilitate proactive ethics conversations about healthcare operations during the contingency phase and ideally lead to ethically stronger health care practices.

Multi-Level Predictors of Discharges Against Medical Advice: Identifying Contributors to Variation Using an All-Payer Database.

ABSTRACT: There is increasing evidence of the role of non-patient-level factors on discharge against medical advice (DAMA), but limited quantitative information regarding the extent of their impact. This study quantifies the contribution of discharge-level and hospital-level factors to the variation in DAMA. We grouped variables from the 2014 National Inpatient Sample data and ran incremental mixed-effects logit models with grouping at the level of the discharge, the hospital, and the census region. We obtained the intraclass correlation coefficients (ICCs), and evaluated the incremental change in ICC. The final sample included 2,687,430 discharges. 12.8% of the identified variation in the probability of DAMA was associated with the hospital, and 1.2% of the variation was associated with the census division in which the hospital was located. The final, fully-adjusted model had 7.3% of variation in DAMA associated with the hospital-level, with the greatest percentage reductions because of the addition of patient demographics. Even after adjusting for measured patient-level characteristics, there was a contribution of non-patient-level factors to DAMA outcomes. The findings identify a role for a multi-level approach to addressing DAMA.

An Exploratory Study of Goals of Care Conversations Initiated with Seriously Ill Veterans in the Emergency Room.

Background: Emergency department (ED) visits are common for older patients with chronic, life-limiting illnesses and may offer a valuable opportunity for clinicians to initiate proactive goals of care conversations (GoCC) to ensure end-of-life care that aligns with the patients' values, goals, and preferences. Objectives: The purpose of this study is to assess whether GoCC are occurring with patients in Department of Veteran Affairs (VA) EDs, to characterize these patients' goals of care and life-sustaining treatment (LST) decisions, and to examine the extent to which palliative or hospice consultations occur following the ED visit. Design: We conducted a cross-sectional retrospective study using health record data. Settings/Subjects: A total of 10,780 patients receiving care in VA, whose first GoCC occurred during an ED visit. Results: Of the patients in the study, approximately half were at least 70 years of age, three-quarters were white, and half had multiple serious disease comorbidities. The percentage of patients who desired cardiopulmonary resuscitation was lower among the highest risk (i.e., of hospitalization and death) patients (64% vs. 51%). The percentage of patients wanting other LSTs (e.g., mechanical ventilation) was higher among the lowest risk patients; and the percentage of patients requesting limits to LSTs was highest among higher risk patients. Eighteen percent of patients had a palliative or hospice care consult within three months of their ED visit. Conclusions: In this study, we verified that GoCC are being initiated in the ED with Veterans at differing stages in their illness trajectory and that higher proportions of higher risk patients preferred to limit LSTs.

Healthcare Resource Utilization Following a Discharge Against Medical Advice: An Analysis of Commercially Insured Adults.

BACKGROUND: A discharge against medical advice (DAMA) is associated with adverse health outcomes. Its association with postdischarge healthcare resource utilization (HcRU) outside an inpatient setting is unknown. This information can help us understand how a DAMA may affect healthcare-seeking behavior following a hospital stay. We evaluated the relationship between a DAMA and 30-day postdischarge HcRU. METHODS: This retrospective cohort study uses a 10% random sample of enrollees in the IQVIA PharMetrics® Plus database. We included individuals aged 18 to 64 years with an inpatient admission during 2007-2015 and continuous insurance coverage. We defined comparison groups as DAMA and routine discharge. Both groups were matched on baseline covariates. We quantified the association between a DAMA and 30-day HcRU, as well as 90-day for sensitivity analysis, with use of generalized linear models for binary outcomes (inpatient readmissions, emergency department [ED] visits) and count outcomes (physician office visits, nonphysician outpatient encounters, prescription drug fills). RESULTS: Of the 457,530 individuals in the unmatched sample, 2,245 (0.5%) had a DAMA. In the matched sample, a DAMA was positively associated with an ED visit (adjusted odds ratio, 2.28; 95% confidence interval, 1.90-2.72) but not with an inpatient readmission. There were no differences between groups based on the count outcomes. A DAMA was positively associated with 90-day HcRU (ie, inpatient readmission, ED visit, and prescription drug fills). CONCLUSION: The relationship between a DAMA and HcRU varied with the HcRU category and postdischarge time interval. This examination of HcRU in the inpatient and outpatient settings provides important information about outcomes following a DAMA.

"Doc, I'm Going for a Walk": Liberalizing or Restricting the Movement of Hospitalized Patients-Ethical, Legal, and Clinical Considerations.

When patients are admitted to the hospital, they are generally expected to remain in or within close proximity to their assigned rooms in order to promote their safety and appropriate medical care. Although there are circumstances when patients may safely leave their hospital room or floor, guidance within the medical literature for the management of patient movement within the hospital are lacking. Excessive restrictions on patient movement may be seen as overly paternalistic, while lax requirements may interfere with high quality care, patient safety and efficient hospital practice. As a result, guidance in the form of institutional policy is warranted. Such policy development should take into consideration the potential clinical, legal, and ethical concerns in balancing the competing values of patients' preferences and respect for autonomy, while ensuring high quality, safe, and efficacious medical care. This paper will provide a framework for hospitals to create institution-specific patient movement policies that are fair, systematic, and transparent.