Pilot Randomized Controlled Trial of an Educational Video for CAR T-Cell Therapy Recipients.

BACKGROUND: CAR T-cell therapy has transformed the treatment of hematologic malignancies, but it is complex and challenging to convey to patients. Educational video interventions are efficacious for improving patient knowledge about cancer therapeutics and informing their care preferences, yet no educational videos have been evaluated in CAR T-cell therapy. METHODS: We conducted a randomized controlled trial comparing an educational video versus usual care in adults (age ≥18 years) with hematologic malignancies receiving CAR T-cell therapy at Massachusetts General Hospital. Intervention participants watched a 13-minute video depicting how CAR T-cell therapy works, logistics, toxicities, prognosis, recovery, and approaches for dealing with prognostic uncertainty. The primary outcome was feasibility (≥60% enrollment rate). Secondary outcomes included acceptability (≥80% reporting comfort with the video), patients' knowledge about CAR T-cell therapy (10-item test), and self-efficacy (Communication and Attitudinal Self-Efficacy Scale-Cancer), decision satisfaction (Decision Conflict Scale), psychological distress (Hospital Anxiety and Depression Scale), and preference for CAR T-cell therapy. RESULTS: We enrolled 79% (80/101) of eligible patients. Of that group, 91% (30/33) reported being very or somewhat comfortable watching the video, and 94% (31/33) would definitely or probably recommend the video. At 1 month, participants in the video arm reported higher self-efficacy (mean difference [MD], 9.2 [95% CI, -4.0 to 22.3]; Cohen's d, 0.32), decision satisfaction (MD, 2.5 [95% CI, 0.7-4.2]; Cohen's d, 0.67), and lower anxiety (MD, -0.8 [95% CI, -2.5 to 0.7]; Cohen's d, 0.26) compared with participants in the usual care arm. At 1 week, both arms reported high preferences for CAR T-cell therapy (video arm, 94% [33/35]; usual care, 84% [27/32]). CONCLUSIONS: We found that an educational video for patients receiving CAR T-cell therapy was feasible and acceptable. The educational video demonstrated promising preliminary effects on patient self-efficacy and decision satisfaction and warrants further study.

Adolescents and young adults with cancer conversations following participation in an advance care planning video pilot.

PURPOSE: Advance care planning (ACP) discussions can help adolescents and young adults (AYAs) communicate their preferences to their caregivers and clinical team, yet little is known about willingness to hold conversations, content, and evolution of care preferences. We aimed to assess change in care preferences and reasons for such changes over time and examine the reasons for engaging or not engaging in ACP discussions and content of these discussions among AYAs and their caregivers. METHODS: We conducted a pilot randomized controlled trial of a novel video-based ACP tool among AYA patients aged 18-39 with advanced cancer and their caregivers. Participants were asked their care preferences at baseline, after viewing the video or hearing verbal description (post questionnaire), and again 3 months later. Three-month phone calls also queried if any ACP conversations occurred since the initial study visit. Study team notes from these phone calls were evaluated using content analysis. RESULTS: Forty-five AYAs and 40 caregivers completed the 3-month follow-up. Nearly half of AYAs and caregivers changed their care preference from post questionnaire to 3-month follow-up. Increased reflection and learning on the topic (n = 45) prompted preference change, with participants often noting the nuanced and context-specific nature of these decisions (n = 20). Most AYAs (60%) and caregivers (65%) engaged in ACP conversation(s), often with a family member. Disease-related factors (n = 8), study participation (n = 8), and a desire for shared understanding (n = 6) were common reasons for initiating discussions. Barriers included disease status (n = 14) and timing (n = 12). ACP discussions focused on both specific wishes for treatment (n = 26) and general conversations about goals and values (n = 18). CONCLUSION: AYAs and caregivers acknowledged the complexity of ACP decisions, identifying obstacles and aids for these discussions. Clinicians should support a personalized approach to ACP that captures these nuances, promoting ACP as an iterative, longitudinal, and collaborative process. TRIAL REGISTRATION: This trial was registered 10/31/2019 with ClinicalTrials.gov (Identifier: NCT0414907).

Structural Barriers to Well-grounded Advance Care Planning for the Seriously Ill: a Qualitative Study of Clinicians' and Administrators' Experiences During a Pragmatic Trial.

BACKGROUND: Advance Care Planning (ACP) comprises an iterative communication process aimed at understanding patients' goals, values, and preferences in the context of considering and preparing for future medical treatments and decision making in serious illness. The COVID pandemic heightened patients' and clinicians' awareness of the need for ACP. OBJECTIVE: Our goal was to explore the experiences of clinicians and administrators in the context of an intervention to improve ACP during the COVID pandemic. DESIGN: Qualitative interview study. PARTICIPANTS: Clinicians and administrators across five sites that participated in the ACP-COVID trial. APPROACH: We conducted semi-structured, qualitative interviews examining the context and approach to ACP. Interviews were analyzed using template analysis to systematically organize the data and facilitate review across the categories and participants. Templates were developed with iterative input and line-by-line review by the analytic team, to reach consensus. Findings were then organized into emergent themes. KEY RESULTS: Across 20 interviews (4 administrators, 16 clinicians) we identified three themes related to how participants thought about ACP: (1) clinicians have varying views of what constitutes ACP; (2) the health system critically shapes ACP culture and norms; and (3) the centrality of clinicians' affective experience and own needs related to ACP. Varying approaches to ACP include a forms-focused approach; a discussion-based approach; and a parental approach. System features that shape ACP norms are (1) the primacy of clinician productivity measures; (2) the role of the EHR; and (3) the culture of quality improvement. CONCLUSIONS: Despite high organizational commitment to ACP, we found that the health system channeled clinicians' ACP efforts narrowly on completion of forms, in tension with the ideal of well-grounded ACP. This resulted in a state of moral distress that risks undermining confidence in the process of ACP and may increase risk of harm for patients, family/caregivers, and providers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04660422.

A Pilot Randomized Trial of an Advance Care Planning Video Decision Support Tool for Adolescents and Young Adults With Advanced Cancer.

BACKGROUND: Adolescents and young adults (AYAs) with advanced cancer often receive intensive end-of-life care, yet it is unclear if this is goal-concordant. Advance care planning (ACP) video tools may promote identification and communication of AYA preferences. PATIENTS AND METHODS: We conducted a dual-site, 1:1 pilot randomized controlled trial of a novel video-based ACP tool in 50 dyads of AYA patients aged 18 to 39 years with advanced cancer and their caregivers. ACP readiness and knowledge, preferences for future care, and decisional conflict were obtained pre, post, and 3 months after the intervention and compared between groups. RESULTS: Of the 50 AYA/caregiver dyads enrolled, 25 (50%) were randomized to the intervention. Participants primarily identified as female, white, and non-Hispanic. Most AYAs (76%) and caregivers (86%) identified their overall goal as life-prolonging preintervention; less identified this goal postintervention (42% AYAs; 52% caregivers). There was no significant difference in change in proportion of AYAs or caregivers choosing life-prolonging care, CPR, or ventilation between arms postintervention or at 3 months. The change in participant scores for ACP knowledge (AYAs and caregivers) and ACP readiness (AYAs) from preintervention to postintervention was greater in the video arm compared with the control arm; the difference in caregivers' scores for decisional conflict from preintervention to postintervention in the video arm was statistically significant (15 vs 7; P=.005). Feedback from the video participants was overwhelmingly positive; of the 45 intervention participants who provided video feedback, 43 (96%) found the video helpful, 40 (89%) were comfortable viewing the video, and 42 (93%) indicated they would recommend the video to other patients facing similar decisions. CONCLUSIONS: Most AYAs with advanced cancer and their caregivers preferred life-prolonging care in advanced illness, with fewer preferring this type of care postintervention. A brief video-based ACP tool was well-liked by participants and improved caregiver decisional certainty. Videos may be a useful tool to inform AYAs and caregivers about end-of-life care options and promote ACP discussions.

Pilot Randomized Controlled Trial of an Advance Care Planning Video Decision Tool for Patients With Advanced Liver Disease.

BACKGROUND & AIMS: Transplant-ineligible patients with advanced liver disease rarely receive timely advance care planning (ACP). Tools are needed to educate these patients about medical interventions available at the end of life to promote ACP. METHODS: This single-site pilot randomized controlled trial assessed the feasibility, acceptability, and preliminary efficacy of an ACP video decision support tool for improving transplant-ineligible advanced liver disease patients' knowledge about and preferences for end-of-life care. Intervention participants watched a 5-minute video depicting 3 levels of goals of care: life-prolonging care (cardiopulmonary resuscitation [CPR] and intubation), life-limiting care (hospitalization, no CPR/intubation), and comfort care. Control subjects received only a verbal narrative of these 3 levels of goals of care. The primary outcome was feasibility (≥60% enrollment rate). Secondary outcomes included acceptability of the video, patients' knowledge of end-of-life care options (6-item test; range, 0-6), and postintervention goals-of-care and CPR or intubation preferences. RESULTS: We enrolled 85% (n = 50 of 59) of eligible patients randomized to the video (n = 26) or verbal (n = 24) arm. In the video arm, 81% of patients reported being very comfortable watching the video. Patients in the video arm had higher mean knowledge scores (5.7 vs 4.8; P < .001) and were less likely to prefer to receive CPR compared with patients in the verbal arm (35% vs 63%; P = .09). CONCLUSIONS: An ACP video decision support tool to improve knowledge about and preferences for end-of-life care is both feasible and highly acceptable to transplant-ineligible patients with advanced liver disease with a high enrollment rate and promising preliminary efficacy. Future studies should examine the efficacy of the ACP video for enhancing the quality of their end-of-life care. (ClinicalTrials.gov, Number: NCT03557086).

Effect of advance care planning video on do-not-hospitalize orders for nursing home residents with advanced illness.

BACKGROUND: The purpose of the study is to evaluate the effect of an Advance Care Planning (ACP) Video Program on documented Do-Not-Hospitalize (DNH) orders among nursing home (NH) residents with advanced illness. METHODS: Secondary analysis on a subset of NHs enrolled in a cluster-randomized controlled trial (41 NHs in treatment arm implemented the ACP Video Program: 69 NHs in control arm employed usual ACP practices). Participants included long (> 100 days) and short (≤ 100 days) stay residents with advanced illness (advanced dementia or cardiopulmonary disease (chronic obstructive pulmonary disease or congestive heart failure)) in NHs from March 1, 2016 to May 31, 2018 without a documented Do-Not-Hospitalize (DNH) order at baseline. Logistic regression with covariate adjustments was used to estimate the impact of the resident being in a treatment versus control NH on: the proportion of residents with new DNH orders during follow-up; and the proportion of residents with any hospitalization during follow-up. Clustering at the facility-level was addressed using hierarchical models. RESULTS: The cohort included 6,117 residents with advanced illness (mean age (SD) = 82.8 (8.4) years, 65% female). Among long-stay residents (n = 3,902), 9.3% (SE, 2.2; 95% CI 5.0-13.6) and 4.2% (SE, 1.1; 95% CI 2.1-6.3) acquired a new DNH order in the treatment and control arms, respectively (average marginal effect, (AME) 5.0; SE, 2.4; 95% CI, 0.3-9.8). Among short-stay residents with advanced illness (n = 2,215), 8.0% (SE, 1.6; 95% CI 4.6-11.3) and 3.5% (SE 1.0; 95% CI 1.5-5.5) acquired a new DNH order in the treatment and control arms, respectively (AME 4.4; SE, 2.0; 95% CI, 0.5-8.3). Proportion of residents with any hospitalizations did not differ between arms in either cohort. CONCLUSIONS: Compared to usual care, an ACP Video Program intervention increased documented DNH orders among NH residents with advanced disease but did not significantly reduce hospitalizations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02612688 .

Knowledge About Risks, Benefits, and Curative Potential of Immunotherapy Among Patients with Advanced Cancer.

BACKGROUND: Immunotherapy is the first-line treatment for melanoma and lung cancer and brings new risks of immune-related adverse events. We aimed to describe patients' knowledge about risks, benefits, and goals of immunotherapy. MATERIALS AND METHODS: We conducted a cross-sectional study of patients with advanced melanoma or non-small cell lung cancer that used a 9-item knowledge survey and questions from the Prognosis and Treatment Perceptions Questionnaire. RESULTS: We surveyed 105 participants (57 with melanoma, 48 with lung cancer) with median age 69 years (range 36-89). Participants' responses revealed knowledge deficits about immunotherapy mechanism of action and lack of awareness about the timing and severity of side effects. One third (34%; 36/105) of participants reported that the primary goal of their treatment is to cure their cancer. CONCLUSION: Given the widespread use of immunotherapy, patients would benefit from educational tools so that they know what to expect regarding side effects and prognosis.

Clinical Outcomes of Patients Hospitalized with Coronavirus Disease 2019 (COVID-19) in Boston.

BACKGROUND: Outcomes of hospitalized patients with COVID-19 have been described in health systems overwhelmed with a surge of cases. However, studies examining outcomes of patients admitted to hospitals not in crisis are lacking. OBJECTIVE: To describe clinical characteristic and outcomes of all patients with COVID-19 who are admitted to hospitals not in crisis, and factors associated with mortality in this population. DESIGN: A retrospective analysis PARTICIPANTS: In total, 470 consecutive patients with COVID-19 requiring hospitalization in one health system in Boston from January 1, 2020 to April 15, 2020. MAIN MEASURES: We collected clinical outcomes during hospitalization including intensive care unit (ICU) admission, receipt of mechanical ventilation, and vasopressors. We utilized multivariable logistic regression models to examine factors associated with mortality. KEY RESULTS: A total of 470 patients (median age 66 [range 23-98], 54.0% male) were included. The most common comorbidities were diabetes (38.5%, 181/470) and obesity (41.3%, 194/470). On admission, 41.9% (197/470) of patients were febrile and 60.6% (285/470) required supplemental oxygen. During hospitalization, 37.9% (178/470) were admitted to the ICU, 33.6% (158/470) received mechanical ventilation, 29.4% (138/470) received vasopressors, 16.4% (77/470) reported limitations on their desire for life-sustaining therapies such as intubation and cardiopulmonary resuscitation, and 25.1% (118/470) died. Among those admitted to the ICU (N=178), the median number of days on the ventilator was 10 days (IQR 1-29), and 58.4% (104/178) were discharged alive. Older age (OR=1.04, P<0.001), male sex (OR=2.14, P=0.007), higher comorbidities (OR=1.20, P=0.001), higher lactate dehydrogenase on admission (2nd tertile: OR=4.07, P<0.001; 3rd tertile: OR=8.04, P<0.001), and the need for supplemental oxygen on admission (OR=2.17, P=0.014) were all associated with higher mortality. CONCLUSIONS: The majority of hospitalized patients with COVID-19 and those who received mechanical ventilation survived. These data highlight the need to examine public health and system factors that contribute to improved outcomes for this population.

Burdensome Transitions of Care for Patients with End-Stage Liver Disease and Their Caregivers.

BACKGROUND: Patients with end-stage liver disease (ESLD) experience frequent readmissions; however, studies focused on patients' and caregivers' perceptions of their transitional care experiences to identify root causes of burdensome transitions of care are lacking. AIM: To explore the transitional care experiences of patients with ESLD and their caregivers in order to identify their supportive care needs. METHODS: We conducted interviews with 15 patients with ESLD and 14 informal caregivers. We used semi-structured interview guides to explore their experiences since the diagnosis of ESLD including their care transitions. Two raters coded interviews independently (κ = 0.95) using template analysis. RESULTS: Participants reported feeling unprepared to manage their informational, psychosocial, and practical care needs as they transitioned from hospital to home after the diagnosis of ESLD. Delay in the timely receipt of supportive care services addressing these care needs resulted in hospital readmissions, emotional distress, caregiver burnout, reduced work capacity, and financial hardship. Participants shared the following resources that they perceived would improve their quality of care: (1) discharge checklist, (2) online resources, (3) mental health support, (4) caregiver support and training, and (5) financial navigation. CONCLUSION: Transitional care models that attend to the informational, psychosocial, and practical domains of care are needed to better support patients with ESLD and their caregivers at the time of diagnosis and beyond. Without attending to the multidimensional care needs of newly diagnosed patients with ESLD and their caregivers, they are at risk of burdensome transitions of care, high healthcare utilization, and poor health-related quality of life.

Randomized trial of a hospice video educational tool for patients with advanced cancer and their caregivers.

BACKGROUND: Patients with advanced cancer and their caregivers have substantial misperceptions regarding hospice, which contributes to its underuse. METHODS: The authors conducted a single-site randomized trial of a video educational tool versus a verbal description of hospice in 150 hospitalized patients with advanced cancer and their caregivers. Patients without a caregiver were eligible. Intervention participants (75 patients and 18 caregivers) viewed a 6-minute video depicting hospice. Control participants (75 patients and 26 caregivers) received a verbal description identical to the video narrative. The primary outcome was patient preference for hospice. Secondary outcomes included patient and/or caregiver knowledge and perceptions of hospice, and hospice use. RESULTS: Between February 2017 and January 2019, approximately 55.7% of eligible patients (150 of 269 eligible patients) and 44 caregivers were enrolled. After the intervention, there was no difference noted with regard to patients' preferences for hospice (86.7% vs 82.7%; P = .651). Patients in the video group reported greater knowledge regarding hospice (9.0 vs 8.4; P = .049) and were less likely to endorse that hospice is only about death (6.7% vs 21.6%; P = .010). Among deceased patients, those assigned to the intervention were more likely to have used hospice (85.2% vs 63.6%; P = .01) and to have had a longer hospice length of stay (median, 12 days vs 3 days; P < .001). After the intervention, caregivers assigned to view the video were more likely to prefer hospice for their loved ones (94.4% vs 65.4%; P = .031), reported greater knowledge concerning hospice (9.7% vs 8.0%; P = .001), and were less likely to endorse that hospice is only about death (0.0% vs 23.1%; P = .066). CONCLUSIONS: A hospice video did not significantly impact patients' preferences for hospice care. Patients with advanced cancer and their caregivers who were assigned to view the video were more informed regarding hospice and reported more favorable perceptions of hospice. Patients were more likely to use hospice and to have a longer hospice length of stay.

Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial.

BACKGROUND: There are few studies of patient-facing decision aids that include supportive kidney care as an option. We tested the efficacy of a video decision aid on knowledge of supportive kidney care among older patients with advanced CKD. METHODS: Participants (age ≥ 65 years with advanced CKD) were randomized to receive verbal or video education. Primary outcome was knowledge of supportive kidney care (score range 0-3). Secondary outcomes included preference for supportive kidney care, and satisfaction and acceptability of the video. RESULTS: Among all participants (n = 100), knowledge of supportive kidney care increased significantly after receiving education (p < 0.01); however, there was no difference between study arms (p = 0.68). There was no difference in preference for supportive kidney care between study arms (p = 0.49). In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of "No" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care. Most felt comfortable watching the video (96%), felt the content was helpful (96%), and would recommend the video to others (96%). CONCLUSIONS: Among older patients with advanced CKD, we did not detect a significant difference between an educational verbal script and a video decision aid in improving knowledge of supportive kidney care or preferences. However, patients who received video education reported high satisfaction and acceptability ratings. Future research will determine the effectiveness of a supportive kidney care video decision aid on real-world patient outcomes. TRIAL REGISTRATION: NCT02698722 (ClinicalTrials.gov).

A mixed methods analysis of patients' advance care planning values in outpatient oncology: Person-Centered Oncologic Care and Choices (P-COCC).

PURPOSE: Person-Centered Oncologic Care and Choices (P-COCC) combines an advance care planning (ACP) value-focused patient interview with a care goal video decision aid. Our randomized study showed that P-COCC was acceptable but increased participant distress, compared with video-alone and usual care study arms. This mixed methods approach explores the ACP values in the P-COCC arm and their relationship to the distress phenomenon. METHODS: Qualitative thematic analysis of the 46 audio-recorded P-COCC interview transcripts with advanced gastrointestinal cancer patients was performed by multiple reviewers. Quantitative (Likert scale) changes in ACP values were compared across study arms. ACP themes and value change were analyzed in participants with increased distress. RESULTS: Transcript analysis resulted in thematic saturation and identified eight distinct themes on ACP values relating to end-of-life wishes, communication needs, and psychosocial supports. Of 98 participants (33 P-COCC, 43 videos, 22 usual care) who completed the change in value measure, there was no difference detected with P-COCC compared with either video (p = 0.052) or usual care (p = 0.105) arms alone, but P-COCC led to a frequency distribution of more change in personal values compared with the other study arms combined (p = 0.043). Among the subset of P-COCC participants with increased distress, there was no statistical relationship with change in values. CONCLUSIONS: The ACP paradigm P-COCC both informs and supports patients in individualized, value-based decision-making. Distress is not associated with changes in ACP values and may be a necessary, at least transient, byproduct of discussing sensitive but pertinent topics about end-of-life medical care.

Addressing guideline and policy changes during pragmatic clinical trials.

While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them. When deliberating appropriate action in the face of external changes during a pragmatic clinical trial, we recommend considering the well-being of the participants, clinical equipoise, and the strength and quality of the evidence associated with the change; involving those charged with data and safety monitoring; and where possible, planning for potential external changes as the trial is being designed. Any solution must balance the primary obligation to protect the well-being of participants with the secondary obligation to protect the integrity of the trial in order to gain meaningful answers to important public health questions.

Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting.

BACKGROUND: The PRagmatic trial Of Video Education in Nursing homes (PROVEN) aims to test the effectiveness of an advance care planning (ACP) video intervention. Relatively little is known about the challenges associated with implementing ACP interventions in the nursing home (NH) setting, especially within a pragmatic trial. To address this research gap, this report sought to identify facilitators of and barriers to implementing PROVEN from the perspective of the Champions charged with introducing the ACP video program delivery to patients and families. METHODS: In semi-structured telephone interviews at 4 and 15 months of the 18-month implementation period, ACP Champions at all PROVEN intervention facilities (N = 119) were asked about their perceptions of program implementation. Forty interviews were purposively sampled, transcribed, and analyzed using a hybrid deductive/inductive approach to thematic analysis incorporating the Consolidated Framework for Implementation Research's domains: Intervention Characteristics (IC), Inner Setting (IS), Characteristics of Individuals (CI), Outer Setting (OS), and Process (P). RESULTS: Implementation facilitators identified by Champions included: the intervention's adaptable mode of presentation and minimal time burden (IC) as well as the program's customizable delivery to patients and families and opportunity for group reflection on implementation among ACP Champions (P). Barriers included mandated protocol-driven aspects of the program (OS), limited time to deliver the intervention (IS), and lack of perceived relevance and emotional readiness for ACP amongst stakeholders (CI). CONCLUSIONS: Despite the promise of PROVEN's intervention for improving ACP in nursing homes, unchangeable setting and characteristics of Champions, patients, and family members presented implementation barriers. Researchers need to engage all program participants (i.e., facility staff, patients, and families), in addition to corporate-level stakeholders, in early pragmatic trial design to minimize such obstacles. Further, despite the facilitating nature of PROVEN's implementation processes, the study encountered tension between scientific rigor and real-world demands. Researchers need to optimize the real-world authenticity of pragmatic trial design while avoiding excessive implementation protocol deviations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02612688. Registered 19 November 2015.

Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure.

BACKGROUND: Conversations about goals of care and cardiopulmonary resuscitation (CPR)/intubation for patients with advanced heart failure can be difficult. This study examined the impact of a video decision support tool and patient checklist on advance care planning for patients with heart failure. METHODS: This was a multisite, randomized, controlled trial of a video-assisted intervention and advance care planning checklist versus a verbal description in 246 patients ≥64 years of age with heart failure and an estimated likelihood of death of >50% within 2 years. Intervention participants received a verbal description for goals of care (life-prolonging care, limited care, and comfort care) and CPR/intubation plus a 6-minute video depicting the 3 levels of care, CPR/intubation, and an advance care planning checklist. Control subjects received only the verbal description. The primary analysis compared the proportion of patients preferring comfort care between study arms immediately after the intervention. Secondary outcomes were CPR/intubation preferences and knowledge (6-item test; range, 0-6) after intervention. RESULTS: In the intervention group, 27 (22%) chose life-prolonging care, 31 (25%) chose limited care, 63 (51%) selected comfort care, and 2 (2%) were uncertain. In the control group, 50 (41%) chose life-prolonging care, 27 (22%) selected limited care, 37 (30%) chose comfort care, and 8 (7%) were uncertain (P<0.001). Intervention participants (compared with control subjects) were more likely to forgo CPR (68% versus 35%; P<0.001) and intubation (77% versus 48%; P<0.001) and had higher mean knowledge scores (4.1 versus 3.0; P<0.001). CONCLUSIONS: Patients with heart failure who viewed a video were more informed, more likely to select a focus on comfort, and less likely to desire CPR/intubation compared with patients receiving verbal information only. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01589120.

Physician-Assisted Suicide and Euthanasia in the ICU: A Dialogue on Core Ethical Issues.

OBJECTIVE: Many patients are admitted to the ICU at or near the end of their lives. Consequently, the increasingly common debate regarding physician-assisted suicide and euthanasia holds implications for the practice of critical care medicine. The objective of this article is to explore core ethical issues related to physician-assisted suicide and euthanasia from the perspective of healthcare professionals and ethicists on both sides of the debate. SYNTHESIS: We identified four issues highlighting the key areas of ethical tension central to evaluating physician-assisted suicide and euthanasia in medical practice: 1) the benefit or harm of death itself, 2) the relationship between physician-assisted suicide and euthanasia and withholding or withdrawing life support, 3) the morality of a physician deliberately causing death, and 4) the management of conscientious objection related to physician-assisted suicide and euthanasia in the critical care setting. We present areas of common ground and important unresolved differences. CONCLUSIONS: We reached differing positions on the first three core ethical questions and achieved unanimity on how critical care clinicians should manage conscientious objections related to physician-assisted suicide and euthanasia. The alternative positions presented in this article may serve to promote open and informed dialogue within the critical care community.

Palliative and end-of-life care in nephrology: moving from observations to interventions.

PURPOSE OF REVIEW: In comparison with patients who have other serious illnesses, patients with advanced kidney disease have a higher rate of intensive care utilization at the end of life and receive palliative care less frequently. Consensus and clinical practice guidelines have therefore recommended the incorporation of palliative care earlier in the disease trajectory. This review summarizes recent literature on this aspect of care and will highlight future directions for patient-centered care within palliative nephrology. RECENT FINDINGS: Patients with advanced kidney disease and their families frequently do not engage effectively with their clinicians to make informed treatment decisions or plan for care at the end of life. Furthermore, racial and ethnic minority patients continue to receive a lower rate of palliative care services compared to other racial groups. Interventions that promote better palliative care communication and education among nephrology clinicians, patients and their families are becoming increasingly more common in nephrology. SUMMARY: Overall, improved understanding of the unique care needs of patients with advanced and end-stage kidney disease provides a solid foundation to improve palliative and end-of-life care delivery among diverse populations in nephrology.

PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization prior to recruitment feasible with 100% participation of facilities randomized to the intervention arm. Critical regulatory issues included minimal risk determination, waiver of informed consent, and determination that nursing home providers were not engaged in human subjects research. Intervention training and implementation were initiated on 5 January 2016 using corporate infrastructures for new program roll-out guided by standardized training elements designed by the research team. Video Status Reports in facilities' electronic medical records permitted "real-time" adherence monitoring and corrective actions. The Centers for Medicare and Medicaid Services Virtual Research Data Center allowed for rapid outcomes ascertainment. Conclusion We must rigorously evaluate interventions to deliver more patient-focused care to an increasingly frail nursing home population. Video decision support is a practical approach to improve advance care planning. PRagmatic trial Of Video Education in Nursing homes has the potential to promote goal-directed care among millions of older Americans in nursing homes and establish a methodology for future pragmatic randomized controlled trials in this complex healthcare setting.

Use of Video Decision Aids to Promote Advance Care Planning in Hilo, Hawai'i.

INTRODUCTION: Advance care planning (ACP) seeks to promote care delivery that is concordant with patients' informed wishes. Scalability and cost may be barriers to widespread ACP, and video decision aids may help address such barriers. AIM: Our primary hypothesis was that ACP documentation would increase in Hilo after ACP video implementation. Secondary hypotheses included increased use of hospice, fewer deaths in the hospital, and decreased costs in the last month of life. SETTING: The city of Hilo in Hawai'i (population 43,263), which is served by one 276-bed hospital (Hilo Medical Center), one hospice (the Hospice of Hilo), and 30 primary care physicians. PROGRAM DESCRIPTION: The intervention consisted of a single, 1- to 4-h training and access to a suite of ACP video decision aids. PROGRAM EVALUATION: Prior to implementation, the rate of ACP documentation for hospitalized patients with late-stage disease was 3.2 % (11/346). After the intervention, ACP documentation was 39.9 % (1,107/2,773) (P < 0.001). Primary care providers in the intervention had an ACP completion rate for patients over 75 years of 37.0 % (1,437/3,888) compared to control providers, who had an average of 25.6 % (10,760/42,099) (P < 0.001). The rate of discharge from hospital to hospice for patients with late-stage disease was 5.7 % prior to the intervention and 13.8 % after the intervention (P < 0.001). The average total insurance cost for the last month of life among Hilo patients was $3,458 (95 % CI $3,051 to 3,865) lower per patient after the intervention when compared to the control region. DISCUSSION: Implementing ACP video decision aids was associated with improved ACP documentation, greater use of hospice, and decreased costs. Decision aids that promote ACP offer a scalable and cost-efficient medium to place patients at the center of their care.

Racial Disparities in End-of-Life Communication and Preferences among Chronic Kidney Disease Patients.

BACKGROUND: Previous studies on end-of-life (EOL) care among patients with chronic kidney disease (CKD) have been largely limited to White hemodialysis patients. In this study, we sought to explore racial variability in EOL communication, care preferences and advance care planning (ACP) among patients with advanced CKD prior to decisions regarding the initiation of dialysis. METHODS: We performed a cross-sectional study between 2013 and 2015 of Black and White patients with stage IV or V CKD (per the Modified Diet in Renal Disease estimation of GFR <30 ml/min/1.73 m2) from 2 academic centers in Boston. We assessed experiences with EOL communication, ACP, EOL care preferences, hospice knowledge, spiritual/religious and cultural beliefs, and distrust of providers. RESULTS: Among 152 participants, 41% were Black. Black patients were younger, had less education, and lower income than White patients (all p < 0.01). Black patients also had less knowledge of hospice compared to White patients (17 vs. 61%, p < 0.01). A small fraction of patients (8%) reported having EOL discussions with their nephrologists and the majority had no advance directives. In multivariable analyses, Blacks were more likely to have not communicated EOL preferences (adjusted OR 2.70, 95% CI 1.08-6.76) and more likely to prefer life-extending treatments (adjusted OR 3.06, 95% CI 1.23-7.60) versus Whites. CONCLUSIONS: As Black and White patients with advanced CKD differ in areas of EOL communication, preferences, and hospice knowledge, future efforts should aim to improve patient understanding and promote informed decision-making.