Co-Designing an Initiative to Increase Shared Access to Older Adults' Patient Portals: Stakeholder Engagement.

BACKGROUND: The patient portal is a widely available secure digital platform offered by care delivery organizations that enables patients to communicate electronically with clinicians and manage their care. Many organizations allow patients to authorize family members or friends-"care partners"-to share access to patient portal accounts, thus enabling care partners to receive their own identity credentials. Shared access facilitates trilateral information exchange among patients, clinicians, and care partners; however, uptake and awareness of this functionality are limited. OBJECTIVE: We partnered with 3 health care organizations to co-design an initiative that aimed to increase shared access registration and use and that can be implemented using existing patient portals. METHODS: In 2020, we undertook a rigorous selection process to identify 3 geographically diverse health care organizations that had engaged medical informatics teams and clinical champions within service delivery lines caring for older adults. We prioritized selecting organizations that serve racially and socioeconomically diverse populations and possess sophisticated reporting capabilities, a stable patient portal platform, a sufficient volume of older adult patients, and active patient and family advisory councils. Along with patients and care partners, clinicians, staff, and other stakeholders, the study team co-designed an initiative to increase the uptake of shared access guided by either an iterative, human-centered design process or rapid assessment procedures of stakeholders' inputs. RESULTS: Between February 2020 and April 2022, 73 stakeholder engagements were conducted with patients and care partners, clinicians and clinic staff, medical informatics teams, marketing and communications staff, and administrators, as well as with funders and thought leaders. We collected insights regarding (1) barriers to awareness, registration, and use of shared access; (2) features of consumer-facing educational materials to address identified barriers; (3) features of clinician- and staff-facing materials to address identified barriers; and (4) approaches to fit the initiative into current workflows. Using these inputs iteratively via a human-centered design process, we produced brochures and posters, co-designed organization-specific web pages detailing shared access registration processes, and developed clinician and staff talking points about shared access and staff tip sheets that outline shared access registration steps. Educational materials emphasized the slogan "People remember less than half of what their doctors say," which was selected from 9 candidate alternatives as resonating best with the full range of the initiative's stakeholders. The materials were accompanied by implementation toolkits specifying and reinforcing workflows involving both in-person and telehealth visits. CONCLUSIONS: Meaningful and authentic stakeholder engagement allowed our deliberate, iterative, and human-centered co-design aimed at increasing the use of shared access. Our initiative has been launched as a part of a 12-month demonstration that will include quantitative and qualitative analysis of registration and use of shared access. Educational materials are publicly available at Coalition for Care Partners.

Core Roles and Responsibilities of Physicians in Hospice Care: A Statement by and for U.S. Hospice and Palliative Care Physicians.

Physicians are integral members of hospice interdisciplinary teams (IDTs). This statement delineates the core roles and responsibilities of hospice medical directors (HMDs) and hospice physicians who are designated by the hospice program to fulfill core HMD responsibilities. In addition, we describe the basic elements of hospice programs' structure and function required for hospice physicians to fulfill their roles and responsibilities. Finally, we call attention to hospice program characteristics and circumstances of the work environment that should raise a hospice physician's concerns that hospice patients and families are at risk of receiving low-quality care. Such factors include lack of a functioning IDT, minimal physician involvement in direct patient care and clinical IDT meetings, inadequate responses to symptom emergencies in patients' homes, and no or limited access to general inpatient and continuous home hospice care. We write as individual physicians who are concerned about troubling variability in access to and quality of U.S. hospice care. This statement arises from the need to protect the safety and well-being of vulnerable seriously ill people with their families from low-quality hospice care. This statement is primarily intended to be a resource to hospice physicians in negotiating employment agreements and justifying staffing and programmatic resources necessary to perform their jobs well. This statement may also serve as a resource and reference for patient advocacy groups, hospice industry leaders, health services oversight organizations, accountability agencies, and legislatures in efforts to ensure the safety, quality, and reliability of hospice care in the United States.

Unmet palliative care service needs: a patient-centred metric.

OBJECTIVES: Financial pressures and competing demands for limited resources highlight the importance of defining the unmet need for specialty inpatient palliative care (PC), demonstrating the value of the service line and making decisions about staffing. One measure of access to specialty PC is penetration, the percentage of hospitalised adults receiving PC consultations. Although useful, additional means of quantifying programme performance are required for evaluating access by patients who would benefit. The study sought to define a simplified method of calculating unmet need for inpatient PC. METHODS: This retrospective observational study analysed electronic health records from six hospitals in one health system in Los Angeles County.Unmet need for PC was defined by the number of hospitalised patients with four or more chronic serious comorbidities without a PC consultation divided by a denominator of all patients with one or more chronic serious conditions (CSCs) without a PC during the hospitalisation. RESULTS: This calculation identified a subset of patients with four or more CSCs that accounts for 10.3% of the population of adults with one or more CSCs who did not receive PC services during a hospitalisation (unmet need). Monthly internal reporting of this metric led to significant PC programme expansion with an increase in average penetration for the six hospitals from 5.9% in 2017 to 11.2% in 2021. CONCLUSIONS: Health system leadership can benefit from quantifying the need for specialty PC among seriously ill inpatients. This anticipated measure of unmet need is a quality indicator that complements existing metrics.

A Standard Set of Value-Based Patient-Centered Outcomes and Measures of Overall Health in Adults.

BACKGROUND: The definition of population-specific outcomes is an essential precondition for the implementation of value-based health care. We developed a minimum standard outcome set for overall adult health (OAH) to facilitate the implementation of value-based health care in tracking, comparing, and improving overall health care outcomes of adults across multiple conditions, which would be of particular relevance for primary care and public health populations. METHODS: The International Consortium for Health Outcomes Measurement (ICHOM) convened an international panel (patients, clinicians, and topic experts). Following the development of a conceptual framework, a modified Delphi method (supported by public consultations) was implemented to identify, in sequence, the relevant domains, the best instruments for measuring them, the timing of measurement, and the relevant adjustment variables. FINDINGS: Outcomes were identified in relation to overall health status and the domains of physical, mental, and social health. Three instruments covering these domains were identified: PROMIS Scale v1.2-Global Health (10 items), WHO Wellbeing Index (5 items), and the WHO Disability Assessment Schedule 2.0 (12 items). Case-mix variables included a range of sociodemographic and biometric measures. Yearly measurement was proposed for all outcomes and most case-mix variables. INTERPRETATION: The ICHOM OAH Standard Set has been developed through consensus-based methods based on predefined criteria following high standards for the identification and selection of high-quality measures The involvements of a wide range of stakeholders supports the acceptability of the set, which is readily available for use and feasibility testing in clinical settings.

Defining the Roles and Research Priorities for Psychedelic-Assisted Therapies in Patients with Serious Illness: Expert Clinicians' and Investigators' Perspectives.

Background: Recent and preprohibition studies show that patients with serious illness might benefit from psychedelic-assisted therapies for a range of symptoms, physical, psychosocial, and existential. Objective: To explore the potential roles and research priorities of these therapies in patients with serious illness. Design, Setting, and Participants: Qualitative study based on semistructured interviews with 17 experts in serious illness care and/or psychedelic research from the United States and Canada. Measurements: The interview guide elicited participants' perspectives on (1) the potential roles of psychedelic-assisted therapies in this setting, (2) research priorities relevant to this population, and (3) the potential for integrating psychedelic-assisted therapies into existing delivery models of serious illness care. We used thematic analysis until thematic saturation. Results: Domain I: Participants had polar views on the therapeutic potential of psychedelic-assisted therapies, ranging from strong beliefs in their medical utility to reluctance about their use in this patient population. They shared concerns related to the risks of adverse effects, such as delirium or worsening of psychological distress. Domain II: Research priorities primarily concerned patients with clinically diagnosed psychosocial distress, such as depression, anxiety, or demoralization. Participants also articulated potential roles extending beyond traditional medical diagnosis. Domain III: Participants emphasized essential safety and efficacy guidelines relevant to the integration of these therapies into existing models of care. Conclusion: This qualitative study highlights issues and priorities for research on psychedelic-assisted therapies in patients with serious illness and proposes a conceptual framework for integrating these therapies into existing delivery models of serious illness care.

Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial.

CONTEXT: There are few randomized controlled trials on the effectiveness of palliative care interventions to improve the care of patients with advanced cancer. OBJECTIVE: To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted from November 2003 through May 2008 of 322 patients with advanced cancer in a rural, National Cancer Institute-designated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont. INTERVENTIONS: A multicomponent, psychoeducational intervention (Project ENABLE [Educate, Nurture, Advise, Before Life Ends]) conducted by advanced practice nurses consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion (n = 161) vs usual care (n = 161). MAIN OUTCOME MEASURES: Quality of life was measured by the Functional Assessment of Chronic Illness Therapy for Palliative Care (score range, 0-184). Symptom intensity was measured by the Edmonton Symptom Assessment Scale (score range, 0-900). Mood was measured by the Center for Epidemiological Studies Depression Scale (range, 0-60). These measures were assessed at baseline, 1 month, and every 3 months until death or study completion. Intensity of service was measured as the number of days in the hospital and in the intensive care unit (ICU) and the number of emergency department visits recorded in the electronic medical record. RESULTS: A total of 322 participants with cancer of the gastrointestinal tract (41%; 67 in the usual care group vs 66 in the intervention group), lung (36%; 58 vs 59), genitourinary tract (12%; 20 vs 19), and breast (10%; 16 vs 17) were randomized. The estimated treatment effects (intervention minus usual care) for all participants were a mean (SE) of 4.6 (2) for quality of life (P = .02), -27.8 (15) for symptom intensity (P = .06), and -1.8 (0.81) for depressed mood (P = .02). The estimated treatment effects in participants who died during the study were a mean (SE) of 8.6 (3.6) for quality of life (P = .02), -24.2 (20.5) for symptom intensity (P = .24), and -2.7 (1.2) for depressed mood (P = .03). Intensity of service did not differ between the 2 groups. CONCLUSION: Compared with participants receiving usual oncology care, those receiving a nurse-led, palliative care-focused intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher scores for quality of life and mood, but did not have improvements in symptom intensity scores or reduced days in the hospital or ICU or emergency department visits. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00253383.

Seriously ill patients' discussions of preparation and life completion: an intervention to assist with transition at the end of life.

OBJECTIVE: Patients approaching the end of life not only face challenges to physical well-being but also threats to emotional and spiritual integrity. Yet, identifying appropriate, effective, and brief interventions to address those concerns has proven elusive. We developed an intervention based on life review and emotional disclosure literatures and conducted a pilot study to determine feasibility and acceptability. This article presents qualitative intervention responses. METHOD: We conducted a three-armed randomized control trial to evaluate the effects of preparation and life completion discussion on health outcomes in patients with advanced serious illness. Hospice-eligible subjects were randomly assigned to one of three groups: (1) intervention (life completion discussion intervention), (2) attention control (relaxation meditation), and control (no intervention). Subjects in the intervention arm met with a facilitator three times. Session 1 focused on life story, Session 2 on forgiveness, and Session 3, on heritage and legacy. RESULTS: Eighteen subjects participated in the pilot intervention interviews. Subjects from a range of socioeconomic backgrounds completed the intervention with equal facility. Results from Session 1 demonstrate narrative responses participants gave as they reconnected with previous life roles, values, and accomplishments. The second session illustrated reflections of choices one might have made differently and exploration of forgiveness offered and sought. Content from the first and second sessions laid the foundation for discussing Session 3's lessons learned and heritage and legacy. Responses are summarized to assist clinicians in anticipating life review content that may improve overall quality of life at the end of life. SIGNIFICANCE OF RESULTS: Discussions of life completion may improve important health outcomes for patients at the end of life. This intervention may provide a brief, standardized, and transportable means for improving the quality of life of patients with advanced serious illness.

The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions.

OBJECTIVE: There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues. METHODS: Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death. RESULTS: Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described. SIGNIFICANCE OF RESULTS: It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.

Taking Psychedelics Seriously.

BACKGROUND: Psychiatric research in the 1950s and 1960s showed potential for psychedelic medications to markedly alleviate depression and suffering associated with terminal illness. More recent published studies have demonstrated the safety and efficacy of psilocybin, MDMA, and ketamine when administered in a medically supervised and monitored approach. A single or brief series of sessions often results in substantial and sustained improvement among people with treatment-resistant depression and anxiety, including those with serious medical conditions. Need and Clinical Considerations: Palliative care clinicians occasionally encounter patients with emotional, existential, or spiritual suffering, which persists despite optimal existing treatments. Such suffering may rob people of a sense that life is worth living. Data from Oregon show that most terminally people who obtain prescriptions to intentionally end their lives are motivated by non-physical suffering. This paper overviews the history of this class of drugs and their therapeutic potential. Clinical cautions, adverse reactions, and important steps related to safe administration of psychedelics are presented, emphasizing careful patient screening, preparation, setting and supervision. CONCLUSION: Even with an expanding evidence base confirming safety and benefits, political, regulatory, and industry issues impose challenges to the legitimate use of psychedelics. The federal expanded access program and right-to-try laws in multiple states provide precendents for giving terminally ill patients access to medications that have not yet earned FDA approval. Given the prevalence of persistent suffering and growing acceptance of physician-hastened death as a medical response, it is time to revisit the legitimate therapeutic use of psychedelics.

An Employer Health Incentive Plan for Advance Care Planning and Goal-Aligned Care.

One strategy to promote workforce well-being has been health incentive plans, in which a company's insured employees are offered compensation for completing a particular health-related activity. In 2015, Providence Health & Services adopted an Advance Care Planning (ACP) activity as a 2015-2016 health incentive option. More than 51,000 employees and their insured relatives chose the ACP incentive option. More than 80% rated the experience as helpful or very helpful. A high proportion (95%) of employees responded that they had someone they trusted who could make medical care decisions for them, yet only 23% had completed an advance directive, and even fewer (11%) had shared the document with their health care provider. The most common reason given for not completing an advance directive was that health care providers had never asked about it. These findings suggest that an insured employee incentive plan can encourage ACP consistent with the health care organizations' values and strategic priorities.

Implementing palliative care studies.

This session focused on issues related to implementation of randomized clinical trials in palliative care studies. Topics discussed included what kinds of clinical sites and patient populations were suitable, what types of clinical investigators (clinical specialty) should be involved in or lead the studies, what multisite mechanisms could be used to conduct the trials, and what funding issues were related to these studies. A trial of operative versus nonoperative management for small bowel obstruction caused by recurrent intra-abdominal cancer was considered. The feasibility of such a trial was examined in terms of whether there was "equipoise" for a majority of likely investigators in the field around the trial question, what other issues might impact accrual to the trial, and how many patients would be required to answer which of these two treatment arms was better. This last question is related to selection of a primary endpoint for the trial and was a modestly contentious issue for the trial design group. Both sensible compromises in endpoint selection and the education of the community of investigators for a particular randomized trial in palliative care are crucial steps for successful implementation. A major conclusion of this session is that implementation considerations are intimately related to the architecture of a specific trial and should be addressed practically and early in the design phase of any randomized trial addressing a palliative care question. In this respect, randomized trials in palliative care are no different than in other fields.

Next of kin perspectives on the experience of end-of-life care in a community setting.

BACKGROUND: Previous studies of end-of-life experience have been conducted primarily in urban medical centers and mostly focused on preferences for rather than experience of care. OBJECTIVE: To describe family end-of-life experience and perceptions of care across clinical settings from a semirural community perspective, identifying experiences associated with patient quality of life as rated by next of kin. DESIGN: Retrospective study using structured interviews with decedents' next of kin and medical chart reviews. SETTING/SUBJECTS: Two hundred seven nonsudden deaths (24 hours of medical care immediately prior to death) in Missoula County, Montana, in 1996-1997. RESULTS: Family respondents rated quality of life for decedents at lifes's end on a 0-10 scale and were grouped according to their rating as good, moderate, or poor quality of life. Significant differences between groups were found for five elements of experience: severity and frequency of pain and other symptoms; ratings of pain management; adherence to care preferences; life enrichment activities; and communication between and among patients, family members, and professional caregivers. Higher family ratings were associated with a member of the health care team being responsible for the patient receiving the best care possible, and having someone familiar with the patient and family available nights and weekends. CONCLUSIONS: Opportunities exist in community health care settings to improve quality of life for people approaching life's end. Clinicians, patients, and patients' families can contribute by engaging in open and ongoing communication about preferences for care, symptoms and their management, activities designed to enrich patients' personal experiences, as well as having patient care coordination and continuity of care on nights and weekends.

Addressing Patient Emotional and Existential Needs During Serious Illness: Results of the Outlook Randomized Controlled Trial.

CONTEXT: Few interventions exist to address patients' existential needs. OBJECTIVES: Determine whether an intervention to address seriously ill patients' existential concerns improves preparation, completion (elements of quality of life [QOL] at end of life), and reduces anxiety and depression. METHODS: A randomized controlled trial comparing outlook intervention, relaxation meditation (RM), and usual care (UC). Measures included primary-a validated measure of QOL at the end of life and secondary-Functional Assessment of Cancer Therapy-General, anxiety (Profile of Mood States), depression (Center for Epidemiological Studies-Depression Scale), and spiritual well-being (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being). Qualitative interviews assessed outlook intervention acceptability. Enrolled patients were nonhospice eligible veterans with advanced cancer, congestive heart failure, chronic obstructive pulmonary disease, end-stage renal disease, or end-stage liver disease. RESULTS: Patients (n = 221) were randomly assigned 1:1:1 to outlook, RM, and UC. Patients were 96% males, 46% with cancer, 58.4% married, and 43.9% of African American origin. Compared with UC, outlook participants had higher preparation (a validated measure of QOL at the end of life) (mean difference 1.1; 95% CI 0.2, 2.0; P = 0.02) and mean completion (1.6; 95% CI 0.05, 3.1; P = 0.04) at the first but not second postassessment. Compared with RM, outlook participants did not show significant differences over time. Exploratory analyses indicated that in subgroups with cancer and low sense of peace, outlook participants had improved preparation at first and not second postassessment, as compared with UC (mean difference 1.4; 95% CI 0.03, 2.7; P = 0.04) (mean difference = 1.8; 95% CI 0.3, 3.3; P = 0.02), respectively. CONCLUSION: Outlook had an impact on social well-being and preparation compared with UC. The lack of impact on anxiety and depression differs from previous results among hospice patients. Results suggest that outlook is not demonstratively effective in populations not experiencing existential or emotional distress.

Promoting excellence in end-of-life care: a report on innovative models of palliative care.

BACKGROUND: Promoting Excellence in End-of Life Care, a national program of The Robert Wood Johnson Foundation, funded 22 demonstration projects representing a wide range of health care settings and patient populations to develop innovative models for delivering palliative care that addressed documented deficiencies in the care of patients and families facing the final stage of life. OBJECTIVE: To determine the practicality (feasibility of development and operation as well as acceptance by stakeholders) of new models of care and to determine the impact of the models on access to, quality of and financing for palliative care. DESIGN: The program cannot report scientifically rigorous outcomes, but the grant-funded projects used a variety of methods and measures to assess acceptance of new models and their impact from the perspectives of various stakeholders, including patients and their families, clinicians, administrators and payers. While it is not possible to aggregate data across projects, the data reported to the Promoting Excellence national program office were used to describe program impact with respect to the practicality of palliative care service integration into existing clinical care settings (feasibility and acceptance by stakeholders), the availability and use of palliative care services (access), quality of care (conformance to patient expectations and accepted clinical standards) and costs of care. SETTINGS AND SUBJECTS: The 22 projects provided services in urban as well as rural settings, in integrated health systems, hospitals, outpatient clinics, cancer centers, nursing homes, renal dialysis clinics, inner city public health and safety net systems and prisons. Populations served included prison inmates, military veterans, renal dialysis patients, Native Americans, Native Alaskans, and African American patients, inner-city medically underserved patients, pediatric patients, and persons with serious mental illness patients. RESULTS: Hosting or adopting institutions sustained or expanded twenty of the 22 models, and feedback from all stakeholders was positive. Project sites developed and utilized new palliative care services and addressed quality through implementation of new standards and clinical protocols. Costs of care, where they could be assessed, were unaffected or decreased for project patients versus historical or concurrent controls. CONCLUSIONS: The 22 Promoting Excellence in End-of Life Care projects demonstrated that by individualizing patient and family assessment, effectively employing existing resources and aligning services with specific patient and family needs, it is possible to expand access to palliative services and improve quality of care in ways that are financially feasible and acceptable to patients, families, clinicians, administrators, and payers.

Peer-professional workgroups in palliative care: a strategy for advancing professional discourse and practice.

BACKGROUND: As part of a comprehensive national effort to improve care at the end of life, the Promoting Excellence in End-of-Life Care program of The Robert Wood Johnson Foundation convened "national peer-professional workgroups" of recognized authorities or leaders to advance palliative aspects of practice in their respective specialties or fields. OBJECTIVE: The conveners' goals were to establish research and practice agendas to integrate palliative care within selected fields and health care settings, and to expand delivery of palliative care to special patient populations that have been underserved by palliative care. We hypothesized that leading professionals within specific fields, chartered to achieve clear goals, and then provided with sufficient administrative and logistical support, could develop recommendations for expanding access to, quality of and financing for palliative care within their disciplines. DESIGN: Staff at the national program office of Promoting Excellence in End-of-Life Care convened eight disease-based, specialty-based or issue-based workgroups (the selected workgroup topics were amyotrophic lateral sclerosis, cost accounting, critical care, end-stage renal disease, human immunodeficiency virus/acquired immune deficiency syndrome [HIV/AIDS] disease, Huntington's disease, pediatric care, and surgical palliative care). The national program office implemented a small group process design in convening the groups, and provided coordination, oversight and administrative support, along with funds to support meetings (telephone and in-person). A workgroup "charter" guided groups in determining the scope of efforts and set specific, time-limited goals. From the outset, the workgroups developed plans for dissemination of workgroup recommendations to defined stakeholder audiences, including health care providers, policy-makers, payers, researchers, funders, educators, professional organizations and patient advocacy groups. SETTING AND SUBJECTS: Groups averaged 25 members and met for an average of 24 months. Promoting Excellence leadership chose workgroup topic areas that addressed patient populations underserved for palliative care, and corresponding professional specialties with demonstrated interest and readiness to improve education, evidence base, and professional expertise in palliative aspects of care. RESULTS: Each workgroup was highly productive and advanced changes in respective fields through developing and disseminating recommendations to their respective fields regarding practice, education, clinical and health service research and policy. Beyond their chartered responsibilities, workgroups also developed educational programs and curricula and a wide array of resources. The workgroups also authored articles for publication, intended to stimulate professional discourse and influence clinical norms and culture. CONCLUSIONS: The national peer-professional workgroup model exceeded original expectations and produced well-considered Recommendations to the Field as well as a body of resources for professionals in expanding access to and quality of palliative care. Results of this experimental venture in professional change suggest that the workgroup model may be a useful, cost-effective, rapid-change strategy for quality improvement in other areas of professional practice and service delivery.

Contracts, covenants and advance care planning: an empirical study of the moral obligations of patient and proxy.

Previously we had speculated that the patient-proxy relationship existed on a contractual to covenantal continuum. In order to assess this hypothesis, and to better understand the moral obligations of the patient-proxy relationship, we surveyed 50 patient-proxy pairs as well as 52 individuals who had acted as proxies for someone who had died. Using structured vignettes representative of three distinct disease trajectories (cancer, acute stroke, and congestive heart failure), we assessed whether respondents believed that proxies should follow explicit instructions regarding life-sustaining therapy and act contractually or whether more discretionary or covenantal judgments were ethically permissible. Additional variables included the valence of initial patient instructions--for example, "to do nothing" or "to do everything"--as well as the quality of information available to the proxy. Responses were graded on a contractual to covenantal continuum using a modified Likert scale employing a prospectively scored survey instrument. Our data indicate that the patient-proxy relationship exists on a contractual to covenantal continuum and that variables such as disease trajectory, the clarity of prognosis, instructional valence, and the quality of patient instructions result in statistically significant differences in response. The use of interpretative or covenantal judgment was desired by patients and proxies when the prognosis was grim, even if initial instructions were to pursue more aggressive care. Nonetheless, there was a valence effect: patients and proxies intended that negative instructions to be left alone be heeded. These data suggest that the delegation of patient self-determination is morally complex. Advance care planning should take into account both the exercise of autonomy and the interpretative burdens assumed by the proxy. Patients and proxies think inductively and contextually. Neither group viewed deviation from patient instructions as a violation of the principal's autonomy. Instead of adhering to narrow notions of patient self-determination, respondents made nuanced and contextually informed moral judgments. These findings have implications for patient education as well as the legal norms that guide advance care planning.

Evaluation of the Missoula-VITAS Quality of Life Index--revised: research tool or clinical tool?

BACKGROUND: Quality of life (QOL) is a central outcome measure in caring for seriously ill patients. The Missoula-VITAS Quality of Life Index (MVQOLI) is a 25-item patient-centered index that weights each of five QOL dimensions (symptoms, function, interpersonal, wellbeing, transcendence) by its importance to the respondent. The measure has been used to assess QOL for hospice patients, and has been found to be somewhat complex to use and analyze. OBJECTIVE: This study aimed to simplify the measure, and evaluate the reliability and validity of a revised version as either a research or clinical tool (i.e., "psychometric" versus "clinimetric"). DESIGN: Two data collection efforts are described. The psychometric study collected QOL data from 175 patients at baseline, 3-5 days, and 21 days later. The implementation study evaluated the feasibility and utility of the MVQOLI-R during over six weeks of use. SETTING/SUBJECTS: End-stage renal patients on dialysis, hospice, or long-term care patients participated in the psychometric study. The implementation study was done in hospice, home health, and palliative care settings. MEASUREMENTS: The MVQOLI-R and the Memorial Symptom Assessment Scale. RESULTS: The psychometric and implementation studies suggest that the MVQOLI-R performs well as a clinical tool but is not powerful as an outcome research instrument. The MVQOLI-R has the heterogeneous structure of clinimetric tools, and demonstrated both relevance and responsiveness. Additionally, in a clinical setting the MVQOLI-R was useful therapeutically for stimulating communication about the psychosocial and spiritual issues important to the tasks of life completion and life closure. CONCLUSIONS: The MVQOLI-R has clinical utility as a patient QOL assessment tool and may have therapeutic utility as a tool for fostering discussion among patients and their clinicians, as well as for helping patients identify sources of suffering and opportunities during this time in their lives.

Hospice benefits and phase I cancer trials.

Medicare denies hospice coverage to patients with terminal illnesses who enroll as participants in phase I studies, which assess the toxicity and dosing of potential treatments for incurable diseases. Federal regulations require patients to forgo curative therapies, and they interpret phase I agents as treatment for the terminal condition for which hospice care was elected. Thus, by enrolling as a participant in a phase I trial, a patient otherwise eligible for hospice is rendered ineligible. Private insurers have similar provisions for children and adults younger than 65 years of age. Such exclusions are not defensible on ethical or clinical grounds. Policymakers, insurers, and institutional review boards all have a role in resolving this problem.