The Need for Specialized Oncology Training for Clinical Ethicists.

Numerous ethical issues are raised in cancer treatment and research. Informed consent is challenging due to complex treatment modalities and prognostic uncertainty. Busy oncology clinics limit the ability of oncologists to spend time reinforcing patient understanding and facilitating end-of-life planning. Despite these issues and the ethics consultations they generate, clinical ethicists receive little if any focused education about cancer and its treatment. As the field of clinical ethics develops standards for training, we argue that a basic knowledge of cancer should be included and offer an example of what cancer ethics training components might look like. We further suggest some specific steps to increase collaboration between clinical ethicists and oncology providers in the outpatient setting to facilitate informed consent and proactively identify ethical issues.

Building family caregiver skills using a simulation-based intervention for care of patients with cancer: protocol for a randomized controlled trial.

BACKGROUND: Family caregivers of patients with cancer undergoing radiation therapy experience significant distress and challenges related to high symptom burden and complex care demands. This is particularly true for caregivers of patients with head and neck, esophageal, anal, rectal, and lung cancers, who are often receiving combined-modality treatment and may have tracheostomy tubes, gastrostomy tubes, or colostomies/ileostomies. This study aims to evaluate a simulation-based nursing intervention to provide information, support, and training to caregivers during radiation therapy. METHODS: This randomized controlled trial will include a sample of 180 patients and their family caregivers. Caregivers assigned to the control group will receive usual care and an informational booklet from the National Cancer Institute (NCI). Those in the intervention group will receive usual care, the NCI booklet, and three meetings with a nurse interventionist during radiation treatment followed by a booster call two weeks posttreatment. Intervention sessions focus on themes consistent with the trajectory of radiation therapy: the patient experience/needs, the caregiver experience and dyad communication, and transition to survivorship. Outcomes are measured at baseline, end of treatment (T2), and 4 (T3) and 20 (T4) weeks posttreatment, with the primary outcome being caregiver anxiety at T4. DISCUSSION: This trial is innovative in its use of simulation in a psychoeducational intervention for family caregivers. The intervention is administered at point-of-care and aimed at feasibility for integration into clinical practice. Patient quality of life and healthcare utilization measures will assess how providing support and training to the caregiver may impact patient outcomes. TRIAL REGISTRATION: The trial was registered on 08/14/2019 at ClinicalTrials.gov (identifier NCT04055948 ).

Association between strong patient-oncologist agreement regarding goals of care and aggressive care at end-of-life for patients with advanced cancer.

INTRODUCTION: The ability of oncologists to understand patients' goals of care is recognized as a key component of quality care. The purpose of this study is to examine the influence of patient-oncologist agreement regarding goals of care upon aggressive care at end of life (EOL) for patients with advanced cancer. METHODS: Patients with advanced cancer and their oncologists were interviewed at study enrollment and every 3 months thereafter until patient death or end of the study period (15 months). A 100-point visual analogue scale was used to represent goals of care, with quality of life (scored as 0) and survival (scored as 100) as anchors. Strong goal of care agreement for survival was defined as oncologist and patient dyadic goal of care scores that fell between 70 and 100 (100 = highest goal for survival) and for comfort, dyadic goal of care values that fell between 0 and 30 (0 = high goal for comfort). RESULTS: Two hundred and six patients and eleven oncologists provided data. At the last interview prior to death, 23.3% of dyads had strong goal of care agreement for either survival (8.3%) or comfort (15%) and 76.7% had no strong agreement. There was a significant association between aggressive care use and categories of dyadic agreement regarding goals of care (p = 0.024, Cramer's V = 0.15). CONCLUSIONS: A large percentage of oncologists did not understand their patients' EOL goals of care. While aggressive care aligned with categories of dyadic agreement for goals of care, high rates of aggressive care were reported.

Making Medical Decisions for Incapacitated Patients Without Proxies: Part II.

In the United States, there is no consensus about who should make decisions in acute but non-emergent situations for incapacitated patients who lack surrogates. For more than a decade, our academic medical center has utilized community volunteers from the hospital ethics committee to engage in shared decision-making with the medical providers for these patients. In order to add a different point of view and minimize conflict of interest, the volunteers are non-clinicians who are not employed by the hospital. Using case examples and interviews with the community members, this paper describes how the protocol has translated into practice over the years since its inception. Members reported comfort with the role as well as satisfaction with the thoroughness of their discussions with the medical team. They acknowledged feelings of moral uncertainty, but expressed confidence in the process. Questions raised by the experience are discussed. Overall, the protocol has provided oversight, transparency, and protection from conflict of interest to the decision-making process for this vulnerable patient population.

Complexity Analysis of Decision-Making in the Critically Ill.

RATIONALE: Despite multiple trials of interventions to improve end-of-life care of the critically ill, there is a persistent lack of understanding of factors associated with barriers to decision-making at the end of life. OBJECTIVE: To apply the principles of complexity science in examining the extent to which transitions to end-of-life care can be predicted by physician, family, or patient characteristics; outcome expectations; and the evaluation of treatment effectiveness. METHODS: A descriptive, longitudinal study was conducted in 3 adult intensive care units (ICUs). Two hundred sixty-four family surrogates of patients lacking decisional capacity and the physicians caring for the patients were interviewed every 5 days until ICU discharge or patient death. MEASUREMENTS: Characteristics of patients, physicians, and family members; values and preferences of physicians and family; and evaluation of treatment effectiveness, expectations for patient outcomes, and relative priorities in treatment (comfort vs survival). The primary outcome, focus of care, was categorized as (1) maintaining a survival orientation (no treatment limitations), (2) transitioning to a stronger palliative focus (eg, some treatment limitations), or (3) transitioning to an explicit end-of-life, comfort-oriented care plan. MAIN RESULTS: Physician expectations for survival and future cognitive status were the only variables consistently and significantly related to the focus of care. Neither physician or family evaluations of treatment effectiveness nor what was most important to physicians or family members was influential. CONCLUSION: Lack of influence of family and physician views, in comparison to the consistent effect of survival probabilities, suggests barriers to incorporation of individual values in treatment decisions.

A family-centered intervention for the transition to living with multiple myeloma as a chronic illness: A pilot study.

Patients with multiple myeloma and their family caregivers must master self-management tasks related not only to the disease and treatment, but also associated with transitioning to living with chronic illness. The aim of this study was to assess the feasibility, acceptability, safety, and fidelity of an intervention that had a psychoeducational approach and included a low-impact, home-based walking activity. A secondary aim was to obtain preliminary data of the effect of the intervention, as compared to an attention control group, on anxiety, activation for self-management, fatigue, depression and health-related quality of life (HRQOL). A sample of 15 adult patients with multiple myeloma and their family caregivers were randomized into either an intervention or attention-control group. The intervention was delivered to the dyad in one session and booster calls were made at 1 and 3 weeks. The control group received printed educational resources and telephone contacts. Measures were done at baseline, and 6 and 12 weeks. Descriptive statistics were used. The intervention was safe, feasible, and acceptable to patients and caregivers. Fidelity was high for the initial session, but low with booster calls. Improvement in scores for activation, fatigue, depression, anxiety, physical HRQOL, and emotional distress was seen in at least 40% of patients in the intervention group. Fewer caregivers in the intervention group showed improvement on the outcome variables. Leveraging a behavioral strategy such as walking, along with supportive and educational resources, is promising for promoting well-being within the patient/caregiver dyad. Further refinement of the intervention is needed to strengthen its efficacy for the caregiver and exploratory work is essential to understand the interpersonal supportive processes associated with the walking activity.

Leveraging the lived experience of surrogate decision makers of the seriously ill to develop a decision support intervention.

BACKGROUND: Surrogate decision makers of seriously ill patients are frequently asked to make healthcare decisions without evidence-based decision support. AIMS: To describe the lived experiences of surrogate decision makers who have made advance care decisions and identify relevant features of a decision support intervention from their perspectives. METHODS: A convenience sample of surrogate decision makers (n=10) of seriously ill patients discharged to an extended care facility within the past 6 months participated in focus group discussions. Data were analyzed using content analysis. RESULTS: Three salient themes were identified: (1) limited preparation, (2) decisional and emotional burden, and (3) content and features of a decision support intervention. CONCLUSIONS: Surrogate decision makers of the seriously ill are not prepared for their new role, and experience decisional and emotional burden. Effective decision support interventions must address the decisional and emotional needs of surrogate decision makers to enhance the quality of their decisions.

Transplant Ethics: Let's Begin the Conversation Anew : A Critical Look at One Institute's Experience with Transplant Related Ethical Issues.

Standardizing consultation processes is increasingly important as clinical ethics consultation (CEC) becomes more utilized in and vital to medical practice. Solid organ transplant represents a relatively nascent field replete with complex ethical issues that, while explored, have not been systematically classified. In this paper, we offer a proposed taxonomy that divides issues of resource allocation from viable solutions to the issue of organ shortage in transplant and then further distinguishes between policy and bedside level issues. We then identify all transplant related ethics consults performed at the Cleveland Clinic (CC) between 2008 and 2013 in order to identify how consultants conceptually framed their consultations by the domains they ascribe to the case. We code the CC domains to those in the Core Competencies for Healthcare Consultation Ethics in order to initiate a broader conversation regarding best practices in these highly complex cases. A discussion of the ethical issues underlying living donor and recipient related consults ensues. Finally, we suggest that the ethical domains prescribed in the Core Competencies provide a strong starting ground for a common intra-disciplinary language in the realm of formal CEC.

Coping Strategies and Posttraumatic Stress Symptoms in Post-ICU Family Decision Makers.

OBJECTIVE: To assess the coping strategies used by family decision makers of adult critical care patients during and after the critical care experience and the relationship of coping strategies to posttraumatic stress symptoms experienced 60 days after hospitalization. DESIGN: A single-group descriptive longitudinal correlational study. SETTING: Medical, surgical, and neurological ICUs in a large tertiary care university hospital. PATIENTS: Consecutive family decision makers of adult critical care patients from August 2012 to November 2013. Study inclusion occurred after the patient's fifth day in the ICU. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Family decision makers of incapacitated adult ICU patients completed the Brief COPE instrument assessing coping strategy use 5 days after ICU admission and 30 days after hospital discharge or death of the patient and completed the Impact of Event Scale-Revised assessing posttraumatic stress symptoms 60 days after hospital discharge. Seventy-seven family decision makers of the eligible 176 completed all data collection time points of this study. The use of problem-focused (p=0.01) and emotion-focused (p<0.01) coping decreased over time while avoidant coping (p=0.20) use remained stable. Coping strategies 30 days after hospitalization (R2=0.50, p<0.001) were better predictors of later posttraumatic stress symptoms than coping strategies 5 days after ICU admission (R2=0.30, p=0.001) controlling for patient and decision-maker characteristics. The role of decision maker for a parent and patient death were the only noncoping predictors of posttraumatic stress symptoms. Avoidant coping use 30 days after hospitalization mediated the relationship between patient death and later posttraumatic stress symptom severity. CONCLUSIONS: Coping strategy use is a significant predictor of posttraumatic stress symptom severity 60 days after hospitalization in family decision makers of ICU patients.

The devil is in the details: confidentiality challenges in the age of genetics.

This clinical case report illustrates the potential dilemmas that can arise from knowledge gained through genetic analysis. These conflicts require careful ethical analysis of presumed duties to protect patient privacy and maintain confidentiality, the duty to warn a second party of a health risk, and the duty of veracity. While the questions raised by genetic testing of one individual for disease that reveals potentially important information about relatives, such as risk for Huntington chorea or breast cancer, have been discussed, the continuing expansion in our capacity for sophisticated genetic analysis continues to present new and challenging situations. The resolution of this case and others like it requires close collaboration among the treatment team, geneticists, and clinical ethicists.

Exploring accountability of clinical ethics consultants: practice and training implications.

Clinical ethics consultants represent a multidisciplinary group of scholars and practitioners with varied training backgrounds, who are integrated into a medical environment to assist in the provision of ethically supportable care. Little has been written about the degree to which such consultants are accountable for the patient care outcome of the advice given. We propose a model for examining degrees of internally motivated accountability that range from restricted to unbounded accountability, and support balanced accountability as a goal for practice. Finally, we explore implications of this model for training of clinical ethics consultants from diverse academic backgrounds, including those disciplines that do not have a formal code of ethics relating to clinical practice.

Hospital lighting and its association with sleep, mood and pain in medical inpatients.

AIMS: To describe light exposure, sleep-wake patterns, mood, pain and their relationships in adult medical inpatients. BACKGROUND: The hospital environment may contribute to patient discomfort by providing a lighting structure that interferes with circadian rhythmicity, sleep, mood and pain. DESIGN: A descriptive correlational design was used in this preliminary study. METHODS: Between May 2011-April 2012, data were collected from a convenience sample of 23 women and 17 men admitted to a large academically affiliated hospital in the United States. Over 72 hours, light exposure and sleep-wake patterns were continuously measured with wrist actigraph/light meters for each participant. Mood was measured daily using the Profile Of Mood States Brief™ Form. Subjective pain scores were abstracted from medical records. RESULTS: Light exposure levels were low: mean daytime light intensity was 104·80 lux. Sleep time was fragmented and low: mean 236·35 minutes of sleep/night. Intra-daily stability scores indicated little sleep-wake synchronization with light. Fatigue and total mood disturbance scores were high and inversely associated with light. Pain levels were also high and positively associated with fatigue, but not directly with light exposure. Low light exposure significantly predicted fatigue and total mood disturbance. CONCLUSION: Medical inpatients were exposed to light levels insufficient for circadian entrainment. Nevertheless, higher light exposure was associated with less fatigue and lower total mood disturbance in participants with pain, suggesting the need for further investigation to determine if manipulating light exposure for medical inpatients would be beneficial in affecting sleep-wake disturbances, mood and pain.

Ethical considerations for conducting a randomized controlled trial in transport.

Although recent studies support the rapid transfer of patients experiencing time-sensitive emergencies, limited data exist to support the use of air transport for nonurgent patient transfers. The nature of medical transport and the heterogeneity of patients who are transferred present unique challenges in designing and conducting clinical research trials that could contribute to the evidence-based decision making for patient care and transport. The current regulatory framework presents several barriers to conducting such research in the medical transport setting. We present a hypothetic study that randomizes patients to either ground or air transport as an exemplar. We discuss informed consent, risk, and the impracticality of conducting community consultations in a medical transport setting. Finally, recommendations for potential changes to current regulations are presented. These are directed at facilitating the conduct of emergency research through a system of oversight that integrates characteristics of quality improvement and health services research.

The impact of patient quality of life and spirituality upon caregiver depression for those with advanced cancer.

OBJECTIVE: Little is known about relationships between patient spiritual well-being and caregiver outcomes for those with advanced cancer. We were interested in examining the relationship between patient physical quality of life (QOL) and caregiver depression and to also evaluate whether patient spiritual well-being (SWB) played a mediating role in this relationship. METHOD: This is a prospective longitudinal study that was conducted in the outpatient clinics at a university-affiliated comprehensive cancer center. 226 patients with Stage III or IV cancer (lung, GI, GYN) and their primary caregivers were interviewed upon enrollment into the study and three months later. Measures of spirituality, health-related quality of life, and physical functioning were included in the interviews. RESULTS: Key findings were that the relationship between patient physical QOL and caregiver depression was inverse and moderate (ß = -0.24, p = 0.004) and that patient SWB (meaning/peace) played a significant (p = 0.02) and medium-size role (ß = -0.31) in mediating the relationship between patient physical QOL and caregiver depression. The nature of these relationships was stable over time. SIGNIFICANCE OF RESULTS: Patients' spirituality is central to their coping and adjusting to cancer. It is this aspect of patient overall quality of life that mediates the relationship to caregiver well-being. The most potent intervention for caregiver depression may be attending to patient spiritual distress.

Professional values, self-esteem, and ethical confidence of baccalaureate nursing students.

Professional identity and competent ethical behaviors of nursing students are commonly developed through curricular inclusion of professional nursing values education. Despite the enactment of this approach, nursing students continue to express difficulty in managing ethical conflicts encountered in their practice. This descriptive correlational study explores the relationships between professional nursing values, self-esteem, and ethical decision making among senior baccalaureate nursing students. A convenience sample of 47 senior nursing students from the United States were surveyed for their level of internalized professional nursing values (Revised Professional Nursing Values Scale), level of self-esteem (Rosenberg's Self-Esteem Scale), and perceived level of confidence in ethical decision making. A significant positive relationship (p < 0.05) was found between nursing students' professional nursing values and levels of self-esteem. The results of this study can be useful to nursing educators whose efforts are focused on promoting professional identity development and competent ethical behaviors of future nurses.

Neglect of quality-of-life considerations in intensive care unit family meetings for long-stay intensive care unit patients.

OBJECTIVE: To examine the frequency with which quality of life and treatment limitation were discussed in formal family meetings for long-stay intensive care unit patients with high risk for mortality and morbidity. DESIGN: Descriptive observational study. SETTING: Five intensive care units. PATIENTS: One hundred sixteen family surrogate decisionmakers of long-stay intensive care unit patients who participated in an intensive communication system that aimed to provide weekly meetings with family decisionmakers. The structure of each meeting was to address medical update, patient preferences, treatment plan, and milestones for evaluating the treatment plan. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We audiotaped initial family meetings for 116 family decisionmakers for a total of 180 meetings. On average, meetings were 24 mins long with a majority of time being devoted to nonemotional speech and little (12%) spent discussing patient preferences. Quality of life was discussed in 45% and treatment limitation in 23% of all meetings. Quality-of-life discussions were more likely to occur when patients were admitted to a medical intensive care unit (odds ratio [OR] 5.9; p = .005), have a family decisionmaker who is a spouse (OR 9.4; p = .0001), were older (OR 1.04; p = 01), have a shorter length of stay (OR 0.93; p = .001), and have a family decisionmaker who was a spouse (OR 5.1; p = .002). For those with a treatment limitation discussion, 67% had a do-not-resuscitate order, 40% were admitted to a medical intensive care unit, 56% had a family decisionmaker who had been their caregiver, and 48% of their family decisionmakers were their children. CONCLUSIONS: To guide discussion with families of the subset of intensive care unit patients with high risk of mortality and long-term morbidity, quality of life was not consistently addressed. Continued efforts to assist clinicians in routinely including discussions of quality-of-life outcomes is needed.

Decisional conflict and regret: consequences of surrogate decision making for the chronically critically ill.

Decisional conflict may predispose surrogate decision makers (SDMs) of the chronically critically ill (CCI) to making health care decisions that are not aligned with the patient's health care preferences and increase the SDM's likelihood of experiencing decision regret. This study establishes the relationship between decisional conflict and decision regret and offers insight on tailoring decision support interventions to the preferences of SDMs of CCI patients.

Exploratory and confirmatory factor analysis of the decision regret scale in recipients of internal cardioverter defibrillators.

The decision regret scale (DRS) is a five-item instrument that captures an individual's regret associated with a healthcare decision. Cross-sectional data were collected from 109 cardiac patients who decided to receive an internal cardioverter defibrillator (ICD). Exploratory and confirmatory factor analyses, assessments of the internal reliability consistency (alpha = .86), and discriminant validity established the DRS as a reliable and valid measure of decision regret in ICD recipients. The DRS, a psychometrically sound instrument, has relevance for clinicians and researchers vested in optimizing the decisional outcomes of ICD recipients. Future research is needed to examine the reliability and validity of the DRS in a larger and more diverse sample of ICD recipients.

The oncology acuity tool: a reliable, valid method for measuring patient acuity for nurse assignment decisions.

BACKGROUND AND PURPOSE: Matching nurse assignments with patient acuity has critical implications for providing safe, effective, and efficient care. Despite this, we lack well-established methods for accurate assessment of acuity. This study aimed to evaluate the reliability and validity of the Oncology Acuity Tool (OAT), which is used for determining nurse assignments. METHODS: Inter-rater reliability and concurrent validity were assessed via surveys of current users of the tool. Content validity data were collected from expert oncology nurses. Predictive validity was assessed by tracking patients who sustained either of two acute events. RESULTS: Findings included high inter-rater reliability, moderately strong concurrent validity, and moderate content validity. Acuity significantly predicted rapid response team consults but not falls. CONCLUSIONS: The OAT demonstrated sufficient reliability and validity for measuring acuity prospectively in this population.