Weighted Lottery to Equitably Allocate Scarce Supply of COVID-19 Monoclonal Antibody.

Importance: Equitable allocation of scarce medications is an important health policy goal. There are few data about attempts to achieve equitable allocation in the community setting. Objective: To describe the development and use of a weighted lottery to allocate a scarce supply of tixagevimab with cilgavimab as preexposure prophylaxis to COVID-19 for immunocompromised individuals and examine whether this promoted equitable allocation to disadvantaged populations. Design, Setting, and Participants: This quality improvement study analyzed a weighted lottery process from December 8, 2021, to February 23, 2022, that assigned twice the odds of drug allocation of 450 tixagevimab with cilgavimab doses to individuals residing in highly disadvantaged neighborhoods according to the US Area Deprivation Index (ADI) in a 35-hospital system in Pennsylvania, New York, and Maryland. In all, 10 834 individuals were eligible for the lottery. Weighted lottery results were compared with 10 000 simulated unweighted lotteries in the same cohort performed after drug allocation occurred. Main Outcomes: Proportion of individuals from disadvantaged neighborhoods and Black individuals who were allocated and received tixagevimab with cilgavimab. Results: Of the 10 834 eligible individuals, 1800 (16.6%) were from disadvantaged neighborhoods and 767 (7.1%) were Black. Mean (SD) age was 62.9 (18.8) years, and 5471 (50.5%) were women. A higher proportion of individuals from disadvantaged neighborhoods was allocated the drug in the ADI-weighted lottery compared with the unweighted lottery (29.1% vs 16.6%; P < .001). The proportion of Black individuals allocated the drug was greater in the weighted lottery (9.1% vs 7.1%; P < .001). Among the 450 individuals allocated tixagevimab with cilgavimab in the ADI-weighted lottery, similar proportions of individuals from disadvantaged neighborhoods accepted the allocation and received the drug compared with those from other neighborhoods (27.5% vs 27.9%; P = .93). However, Black individuals allocated the drug were less likely to receive it compared with White individuals (3 of 41 [7.3%] vs 118 of 402 [29.4%]; P = .003). Conclusions and Relevance: The findings of this quality improvement study suggest an ADI-weighted lottery process to allocate scarce resources is feasible in a large health system and resulted in more drug allocation to and receipt of drug by individuals who reside in disadvantaged neighborhoods. Although the ADI-weighted lottery also resulted in more drug allocation to Black individuals compared with an unweighted process, they were less likely to accept allocation and receive it compared with White individuals. Further strategies are needed to ensure that Black individuals receive scarce medications allocated.

Prevalence of long-term decision regret and associated risk factors in a large cohort of ICU surrogate decision makers.

BACKGROUND: Whether surrogate decision makers regret decisions about the use of life support for incapacitated, critically ill patients remain uncertain. We sought to determine the prevalence of decision regret among surrogates of adult ICU patients and identify factors that influence regret. METHODS: We conducted a secondary analysis of data from the PARTNER 2 trial, which tested a family support intervention for surrogates of critically ill adults. At 6-month follow-up, surrogates rated their regret about life support decisions using the Decision Regret Scale (DRS), scored from 0 to 100, with higher scores indicating more regret. We used multiple linear regression to identify covariates associated with decision regret based on a psychological construct of regret. We constructed two models using the full cohort; model 1 included patient outcomes; model 2 focused on covariates known at the time of ICU decision-making. Subgroup analyses were also conducted based on patient survival status at hospital discharge and 6-month follow-up. RESULTS: 748 of 848 surrogates had complete DRS data. The median (IQR) DRS score was 15 (0, 25). Overall, 54% reported mild regret (DRS 5-25), 19% moderate-strong regret (DRS 30-100), and 27% no regret (DRS 0). Poor patient outcome at 6 months (death or severe functional dependence) was associated with more regret in model 1 (ß 10.1; 95% C.I. 3.2, 17.0). In model 2, palliative care consultation (3.0; 0.1, 5.9), limitations in life support (LS) prior to death (6.3; 3.1, 9.4) and surrogate black race (6.3; 0.3, 12.3) were associated with more regret. Other modulators of regret in subgroup analyses included surrogate age and education level, surrogate-patient relationship, death in hospital (compared to the post-discharge period), and code status at time of ICU admission. CONCLUSIONS: One in five ICU surrogate decision makers experience moderate to strong regret about life support decisions in ICU. Poor patient outcomes are linked to more regret. Decisions to limit life support prior to patient death may also increase regret. Future studies are needed to understand how regret relates to decision quality and how to lessen lasting regret.

Delphi-endorsed Communication Skills Clinicians Need to Care for Hospitalized Incapacitated Patients.

Background: The National Academy of Medicine recently identified improving clinicians' serious illness communication skills as a necessary step in improving patient and family outcomes near the end of life, but there is not an accepted set of core communication skills for engaging with surrogate decision makers. Objective: To determine the core serious illness communication skills clinicians should acquire to care for incapacitated, hospitalized patients with acute, life-threatening illness, including patients with Alzheimer's disease and related dementias. Methods: From January 2019 to July 2020, we conducted a modified Delphi study with a panel of 79 experts in the field of serious illness communication. We developed a preliminary list of candidate communication skills through a structured literature review. We presented the candidate skills to the panelists in the context of three prototypical serious illness conversations. Over three rounds, panelists first augmented the list of candidate skills, then voted on the skills. The final set included skills deemed "very important" or "essential" by 70% of panelists. For external validation, we engaged 11 practicing clinicians and 7 community stakeholders for their perspectives on the expert-endorsed list of skills. Results: The panelists' ratings indicate the importance of a diverse set of communication skills related to providing clear information exchange as well as emotional and psychological support to surrogates. The final set included 33 skills, 12 of which were endorsed for all three prototypical serious illness conversations. Practicing clinicians and community stakeholders supported the expert-endorsed framework with only minor additions. Conclusion: We generated a stakeholder-endorsed list of skills that can inform the content of communication skills training programs for clinicians who care for incapacitated patients in the inpatient setting. The skills go beyond those required to provide traditional cognitive decision support and suggest the need for a paradigm shift in curricular content for communication training.

ProPACC: Protocol for a Trial of Integrated Specialty Palliative Care for Critically Ill Older Adults.

BACKGROUND: Each year, approximately one million older adults die in American intensive care units (ICUs) or survive with significant functional impairment. Inadequate symptom management, surrogates' psychological distress and inappropriate healthcare use are major concerns. Pioneering work by Dr. J. Randall Curtis paved the way for integrating palliative care (PC) specialists to address these needs, but convincing proof of efficacy has not yet been demonstrated. DESIGN: We will conduct a multicenter patient-randomized efficacy trial of integrated specialty PC (SPC) vs. usual care for 500 high-risk ICU patients over age 60 and their surrogate decision-makers from five hospitals in Pennsylvania. INTERVENTION: The intervention will follow recommended best practices for inpatient PC consultation. Patients will receive care from a multidisciplinary SPC team within 24 hours of enrollment that continues until hospital discharge or death. SPC clinicians will meet with patients, families, and the ICU team every weekday. SPC and ICU clinicians will jointly participate in proactive family meetings according to a predefined schedule. Patients in the control arm will receive routine ICU care. OUTCOMES: Our primary outcome is patient-centeredness of care, measured using the modified Patient Perceived Patient-Centeredness of Care scale. Secondary outcomes include surrogates' psychological symptom burden and health resource utilization. Other outcomes include patient survival, as well as interprofessional collaboration. We will also conduct prespecified subgroup analyses using variables such as PC needs, measured by the Needs of Social Nature, Existential Concerns, Symptoms, and Therapeutic Interaction scale. CONCLUSIONS: This trial will provide robust evidence about the impact of integrating SPC with critical care on patient, family, and health system outcomes.

An Online Training Program to Improve Clinicians' Skills in Communicating About Serious Illness.

BACKGROUND: Large-scale efforts to train clinicians in serious-illness communication skills are needed, but 2 important gaps in knowledge remain. (1) No proven training method exists that can be readily scaled to train thousands of clinicians. (2) Though the value of interprofessional collaboration to support incapacitated patients' surrogates is increasingly recognized, few interventions for training intensive care unit (ICU) nurses in important communication skills can be leveraged to provide interprofessional family support. OBJECTIVE: To develop and test a web/videoconference-based platform to train nurses to communicate about serious illness. METHODS: A user-centered process was used to develop the intervention, including (1) iteratively engaging a stakeholder panel, (2) developing prototype and beta versions of the platform, and (3) 3 rounds of user testing with 13 ICU nurses. Participants' ratings of usability, acceptability, and perceived effectiveness were assessed quantitatively and qualitatively. RESULTS: Stakeholders stressed that the intervention should leverage interactive learning and a streamlined digital interface. A training platform was developed consisting of 6 interactive online training lessons and 3 group-based video-conference practice sessions. Participants rated the program as usable (mean summary score 84 [96th percentile]), acceptable (mean, 4.5/5; SD, 0.7), and effective (mean, 4.8/5; SD, 0.6). Ten of 13 nurses would recommend the intervention over 2-day in-person training. CONCLUSIONS: Nurses testing this web-based training program judged it usable, acceptable, and effective. These data support proceeding with an appropriately powered efficacy trial.

A Pilot Randomized Trial of an Interactive Web-based Tool to Support Surrogate Decision Makers in the Intensive Care Unit.

Rationale: Breakdowns in clinician-family communication in intensive care units (ICUs) are common, yet there are no easily scaled interventions to prevent this problem.Objectives: To assess the feasibility, usability, acceptability, and perceived effectiveness of a communication intervention that pairs proactive family meetings with an interactive, web-based tool to help surrogates prepare for clinician-family meetings.Methods: We conducted a two-arm, single-blind, patient-level randomized trial comparing the Family Support Tool with enhanced usual care in two ICUs in a tertiary-care hospital. Eligible participants included surrogates of incapacitated patients judged by their physicians to have ≥40% risk of death or severe long-term functional impairment. The intervention group received unlimited tool access, with prompts to complete specific content upon enrollment and before two scheduled family meetings. Before family meetings, research staff shared with clinicians a one-page summary of surrogates' main questions, prognostic expectations, beliefs about the patient's values, and attitudes about goals of care. The comparator group received usual care enhanced with scheduled family meetings. Feasibility outcomes included the proportion of participants who accessed the tool before the first family meeting, mean number of logins, and average tool engagement time. We assessed tool usability with the System Usability Scale, assessed tool acceptability and perceived effectiveness with internally developed questionnaires, and assessed quality of communication and shared decision-making using the Quality of Communication questionnaire.Results: Of 182 screened patients, 77 were eligible. We enrolled 52 (67.5%) patients and their primary surrogate. Ninety-six percent of intervention surrogates (24/25) accessed the tool before the first family meeting (mean engagement time, 62 min ± 27.7) and logged in 4.2 times (±2.1) on average throughout the hospitalization. Surrogates reported that the tool was highly usable (mean, 82.4/100), acceptable (mean, 4.5/5 ± 0.9), and effective (mean, 4.4/5 ± 0.2). Compared with the control group, surrogates who used the tool reported higher overall quality of communication (mean, 8.9/10 ± 1.6 vs. 8.0/10 ± 2.4) and higher quality in shared decision-making (mean, 8.7/10 ± 1.5 vs. 8.0/10 ± 2.4), but the difference did not reach statistical significance.Conclusions: It is feasible to deploy an interactive web-based tool to support communication and shared decision-making for surrogates in ICUs. Surrogates and clinicians rated the tool as highly usable, acceptable, and effective.

Developing the family support tool: An interactive, web-based tool to help families navigate the complexities of surrogate decision making in ICUs.

INTRODUCTION: Although family members of incapacitated, critically ill patients often struggle in the role of surrogate decision maker, there are no low-cost, easily-scaled interventions to address this problem. AIM OF THE STUDY: To develop and pilot-test the Family Support Tool, an interactive, web-based tool to help individuals navigate the complexities of surrogate decision making in ICUs. MATERIAL AND METHODS: We used a mixed methods, user-centered process to create the Family Support Tool, including: 1) creation of a preliminary design by an expert panel; 2) engagement of a key stakeholder panel to iteratively refine the preliminary design; 3) user testing of a low-fidelity prototype of the tool by 6 former ICU surrogates; 4) creation of a web-based prototype; and 5) user testing of the web-based prototype with 14 surrogates and ICU physicians, including semi-structured interviews and quantitative measurement of usability, acceptability, and perceived effectiveness. RESULTS: The initial design contained a collection of videos and exercises designed to help individuals understand the surrogate's role and think through the patient's values and preferences. Based on family stakeholders' feedback about the emotional overwhelm they experience early in an ICU stay, we redesigned the tool to be viewed in sections, with the first section focused on decreasing surrogates' emotional distress, and later sections focused on helping surrogates prepare for family meetings. Surrogates actively making decisions in the ICU judged the final tool to be highly usable (mean summary score 83.5, correlating to 95th percentile when normalized to devices of its type), acceptable (mean 4.2 +/- 0.5 out of 5), and effective (mean 4.3 +/- 0.6 out of 5). All surrogates reported the tool helped them consider goals of care and all indicated they would recommend the tool to a friend. CONCLUSIONS: We successfully developed a web-based tool to help individuals navigate the complexities of surrogate decision making in ICUs that has high potential for scalability. Surrogates judged the tool to be usable, acceptable, and effective. These data support proceeding to test the tool in a pilot randomized clinical trial.