DeMartino, Erin S.

Abstract Rationale The United States has the highest per capita incarceration rate of any developed democracy. As the incarcerated population ages, medically complex and frail patients are increasingly hospitalized in the community, often arriving without decisional capacity and with limited family involvement. This is the first analysis of state laws and policies governing decision-making for incapacitated incarcerated patients. Methods Two team members independently conducted Westlaw and Internet searches for statutes, regulations and department of corrections (DOC) policies from 50 states and the District of Columbia, identifying language about medical decision-making for incapacitated incarcerated patients. These parallel searches were merged into a single database and reviewed by the analytic team, who created a codebook of inductively and deductively derived themes, guided by principles of grounded theory. The codebook was then systematically applied to the database by 2 independent coders; all data were double-coded. Disputes were resolved by consensus with the entire analytic team, in consultation with a legal scholar. Results Thirty-four of 51 jurisdictions have language addressing decision-making for incapacitated incarcerated patients. Data collected include the definition and determination of incapacity, language affirming incarcerated persons’ right to autonomy in medical decision-making, approaches to decision-making for patients with and without surrogate decision-makers, and whether treatment over patient/surrogate objection is authorized. Assertions about the importance of advance care planning (n = 25) are often undercut by procedural hurdles (n = 20), such as complex witnessing requirements for advance directive completion. Many jurisdictions (n = 26) allow family or friends to serve as legally recognized decision-makers. Thirteen jurisdictions exclude an incarcerated person from serving as decision-maker for another incarcerated person. Fourteen jurisdictions have provisions allowing for treatment over the objection of a patient or their surrogate. While approaches to unrepresented patients differ widely (Figure), 5 jurisdictions grant narrow decisional authority to treating physicians and 4 jurisdictions authorize correctional employees to make medical decisions. Conclusion A heterogeneous assortment of laws, policies and regulations govern the care of incapacitated incarcerated patients, with wide variation observed from jurisdiction to jurisdiction. One-third of jurisdictions lack policies or language regarding decision-making processes for incapacitated incarcerated patients. Even more troubling, 14 jurisdictions allow treatment over a patient or surrogate’s objection and 4 jurisdictions delegate authority over decisions for unrepresented patients to correctional employees, such as the prison medical director or the warden. These findings raise serious concerns about autonomy, beneficence and justice. National reform is needed to align correctional policies with established ethical standards for surrogate decision-making. This abstract is funded by: National Institute on Aging

Abstract Introduction The COVID-19 pandemic exposed underrecognized structural deficiencies in pandemic preparedness across the US, particularly impacting marginalized and medically vulnerable populations. State leaders who were developing policies to allocate critical care resources, often called crisis standards of care (CSC), confronted challenges such as whether and how to incorporate age and chronic conditions into triage protocols, how to contend with imperfect illness acuity scores such as the sequential organ failure assessment (SOFA), and whether essential worker status or area deprivation index (ADI) ought to confer an advantage during triage. To our knowledge, this is the first analysis to highlight CSC writers’ approach to ethical challenges, including from states whose policies provoked corrective action from the Office of Civil Rights (OCR). This study explores how state leaders navigated ethical controversies underlying states’ CSC policies, including whether those controversies were satisfactorily resolved. Methods Between February-September 2022 we conducted semi-structured interviews of public health leaders tasked with developing their states’ (CSC) policies. Interviews were transcribed verbatim and a codebook was developed iteratively, using inductively and deductively derived themes based on principles of grounded theory. The codebook was systematically applied to transcripts; disputes were resolved by consensus discussion among analytic team members. Results Leaders from 34 states were interviewed. Participants described how their states’ CSC policy writing committees considered the role of age in triage, some proposing age as a tiebreaker, or considering age only if coupled with measures of frailty or chronic illness, with others proposing age as an “exclusion criterion.” Many leaders acknowledged a controversial approach to disability in early versions of their policies, some describing how they responded to civil rights complaints. Participants described debates over whether pandemic triage decisions should advantage patients from underserved populations or affirmatively consider essential worker status or pregnancy. While most leaders regretted that early iterations of their policies stood to exacerbate health disparities, others described a less conciliatory response to civil rights complaints. In particular, triage exclusion criteria, whereby certain patients would be excluded outright from certain resources, provoked intense debate. Conclusion We describe ethical controversies that stymied CSC policy writing committees during the COVID-19 pandemic. Leaders described spirited debate around how age, disability, and justice ought to factor into triage; few described satisfactory resolution to those debates. Improved community engagement and adherence to civil rights protections in CSC are imperative to protect marginalized populations as we prepare for future calamites, whether global or local. This abstract is funded by: R03 AG73987; K76 AG88403

ABSTRACT Background The COVID‐19 pandemic presented unprecedented challenges to hospital system and critical care resources, leading to significant changes to operations and patient care. There are limited national data on these changes and instances of unsanctioned deviations from patient care, yet understanding the COVID response is key to future preparedness efforts. We sought to understand how hospitals and states navigated scarcity during COVID‐19, particularly in the absence of a declaration of crisis standards of care. Methods Between February 2022 and September 2022 we conducted 34 interviews with 36 leaders of U.S. states' COVID‐19 planning and response efforts. Interviews were transcribed verbatim and verified. We analyzed interviews using iterative inductive thematic analysis for descriptions of resource scarcity and changes to policies and procedures to prevent rationing lifesaving care. Results Nearly all participants described equipment and personnel scarcity in their home institution or state during COVID‐19. Hospitals across regions and states developed formal and informal coordination processes for load and resource sharing in response to influxes of high‐acuity patients, avoiding formal rationing of lifesaving resources in many regions. Participants also described unsanctioned patient triage, early discharge, and patients counseled to accept less aggressive care (e.g., premature transition to hospice) in states that had not declared crisis standards of care. Conclusions Extending limited resources and inter‐institutional collaboration helped avoid formal rationing. Yet, patient care was unquestionably impacted due to scarcity, both real and perceived. Reports of using hospital triage protocols to deny patients lifesaving care outside of formally recognized crisis conditions and attempts to nudge patients to accept less‐resource‐intensive care are concerning. This may have had disproportionate effects on older adults, individuals with disabilities, and racial and ethnic minoritized groups. To avoid unsanctioned deviations from standard practice in future health emergencies, we recommend that transparent and equitable triage protocols are implemented with robust oversight.

This cross-sectional study evaluates US state regulation of clinician decisions about life-sustaining treatment for adults, including justifications and regulatory requirements.

Abstract Rationale: The US prison population carries a high burden of chronic disease and disability, with older adults constituting the fastest growing subpopulation. When medical needs exceed a prison's healthcare service capabilities, incarcerated patients are transported to clinics and hospitals in surrounding communities. The influence of prison policies on off-site medical care of incarcerated patients is poorly understood. This study aims to identify and classify correctional policies regulating the care of incarcerated patients in community hospitals. Methods: Between 6/2024-10/2024 we searched the Internet for policies from states’ Departments of Corrections (DOC) pertaining to healthcare of incarcerated patients. We compiled, reconciled and organized those policies according to date, jurisdiction and relevance to hospital care. We then developed a preliminary thematic coding scheme and, using mixed inductive and deductive content analysis, two coders independently applied our codebook to each policy. Any coding discrepancies were resolved by consensus, and when necessary, with adjudication by a third team member. Results: Forty-eight state DOCs and the District of Columbia (totaling 49 “states”) have publicly available policies pertaining to healthcare. Among these, 20/49 (41%) have policies pertaining to the protection of bodily privacy during healthcare encounters. Separately, 31 (63%) have policies regarding the confidentiality of incarcerated patients’ medical encounters and records. Thirty-four (69%) maintain policies regarding incarcerated individuals’ right to select and consent to treatment. Thirty-three (67%) include language about the right to refuse treatment. Twenty-six states (53%) direct that incarcerated individuals be informed of their right to access healthcare either in writing (22/49; 45%), verbally (20/49; 41%), or through posted signage (5/49; 10%). Twenty-one states (43%) address shackling during off-site medical care, but only 15 (31%) address responding to requests from off-site clinicians to minimize or remove patients’ restraints. Just 4/49 states (8%) use person-centered language (avoiding terms like “offender” and “inmate”). Policy excerpts addressing key domains are depicted in the Table. Conclusions: Correctional policies regarding the care of incarcerated patients in community hospitals vary significantly in scope and content across states. While incarcerated people have a Constitutionally protected right to accept or refuse healthcare, including making their own treatment decisions, many state policies do not explicitly mandate how these disclosures must be communicated to patients or their healthcare providers. These silences, when combined with security measures like shackling and the ubiquitous presence of officers, countermand person-centered care and undermine the ability of hospital healthcare professionals to uphold the rights and dignity of incarcerated patients.

Abstract Rationale: Disparities in unilateral clinician decisions to decline initiating or maintaining life-sustaining treatment (LST) exist. We aimed to determine 1) which US state statutes support unilateral clinician decisions to decline initiating or maintaining LST; 2) what requirements, if any, must be met for these unilateral clinician decisions to occur; and 3) which state statutes address concerns for sociodemographic disparities associated with these decisions. Methods: Between September and October 2024, we used Fastcase, Casetext and official US state government websites to identify statutes for all US states and Washington, DC that addressed clinician decisions to decline to initiate or maintain LST. We defined reason of conscience as explicit mention of conscience, religion, ethics or moral reasons supporting unilateral clinician decision-making. Two reviewers independently analyzed each statute resolving disagreements with consensus adjudication. Results: Almost all (98%, n=50/51) statutes explicitly support unilateral clinician decisions to decline initiating or maintaining at least one form of LST. Reasons supporting these decisions varied across states including medical reasons only (16%), reasons of conscience only (22%), both medical reasons and reasons of conscience (35%), or no medical or conscience reason explicitly provided (25%). Medical reasons supporting unilateral clinician decisions included if LST was “medically ineffective” (24%), “contrary to medical standards” (14%), “medically inappropriate” (10%), or “nonbeneficial” (8%). For states supporting unilateral clinician decisions if LST was medically ineffective, 75% also supported LST to be declined for reason of conscience while 25% did not. When using medical reasons to support unilateral clinician decisions to decline LST, many statutes require that clinicians must first inform patient/surrogate of this decision (37%) and cooperate with transferring the patient to another clinician or institution (75%). Statutes rarely directly required clinicians to obtain a second medical opinion (8%), pursue a medical ethics committee review (6%), or address conflict (2%) in these situations. Although no state statutes explicitly acknowledged the existence of sociodemographic disparities associated with unilateral clinician decisions to initiate or maintain LST, 27% included guidance that addressed decisions to withhold or withdraw LST in specific marginalized groups. Conclusions: While almost all US state statutes allowed clinicians to decline to initiate or maintain LST, the reasons supporting and actions required to pursue these decisions varied. No statute explicitly addressed sociodemographic disparities associated with these decisions, which may perpetuate these disparities across the US.

ABSTRACTOf the many burdens cancer patients face, the impact on personal finances is often invisible to clinicians. Financial toxicity refers to the negative impact on patients’ and families’ quality of life due to a combination of high out‐of‐pocket costs of medical treatment, diminished savings, and psychological distress as a result of diminished finances. Financial toxicity in cancer care has been more closely examined in the standard‐of‐care setting. Financial toxicity in the early phase clinical trial setting, and the ethical implications of making patients pay out of pocket to access experimental interventions that may not have therapeutic benefit, have yet to be explored. This article seeks to highlight hidden costs of clinical trial participation in the U.S., and to illustrate how patients are susceptible to financial toxicity from nonmedical direct costs and indirect costs even though a trial intervention itself is not charged to the patient. We argue that not informing prospective participants of the potential costs of trial participation threatens their autonomy and interferes with researchers’ prima facie duties to beneficence and nonmaleficence.

This Viewpoint discusses addressing inadequate documentation of unilateral do-not-resuscitate orders in the electronic health record.