"Diving in the deep-end and swimming": a mixed methods study using normalization process theory to evaluate a learning collaborative approach for the implementation of palliative care practices in hemodialysis centers.

BACKGROUND: Normalization Process Theory (NPT) is an implementation theory that can be used to explain how and why implementation strategies work or not in particular circumstances. We used it to understand the mechanisms that lead to the adoption and routinization of palliative care within hemodialysis centers. METHODS: We employed a longitudinal, mixed methods approach to comprehensively evaluate the implementation of palliative care practices among ten hemodialysis centers participating in an Institute for Healthcare Improvement Breakthrough- Series learning collaborative. Qualitative methods included longitudinal observations of collaborative activities, and interviews with implementers at the end of the study. We used an inductive and deductive approach to thematic analysis informed by NPT constructs (coherence, cognitive participation, collective action, reflexive monitoring) and implementation outcomes. The NoMAD survey, which measures NPT constructs, was completed by implementers at each hemodialysis center during early and late implementation. RESULTS: The four mechanisms posited in NPT had a dynamic and layered relationship during the implementation process. Collaborative participants participated because they believed in the value and legitimacy of palliative care for patients receiving hemodialysis and thus had high levels of cognitive participation at the start. Didactic Learning Sessions were important for building practice coherence, and sense-making was solidified through testing new skills in practice and first-hand observation during coaching visits by an expert. Collective action was hampered by limited time among team members and practical issues such as arranging meetings with patients. Reflexive monitoring of the positive benefit to patient and family experiences was key in shifting mindsets from disease-centric towards a patient-centered model of care. NoMAD survey scores showed modest improvement over time, with collective action having the lowest scores. CONCLUSIONS: NPT was a useful framework for understanding the implementation of palliative care practices within hemodialysis centers. We found a nonlinear relationship among the mechanisms which is reflected in our model of implementation of palliative care practices through a learning collaborative. These findings suggest that the implementation of complex practices such as palliative care may be more successful through iterative learning and practice opportunities as the mechanisms for change are layered and mutually reinforcing. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04125537 . Registered 14 October 2019 - Retrospectively registered.

Recommendations for Public Policy Changes to Improve Supportive Care for Seriously Ill Patients With Kidney Disease.

National and international nephrology organizations have identified substantial unmet supportive care needs of patients with kidney disease and issued recommendations. In the United States, the most recent comprehensive effort to change kidney care, the Advancing American Kidney Health Initiative, does not explicitly address supportive care needs, although it attempts to implement more patient-centered care. This Perspective from the leaders of the Coalition for Supportive Care of Kidney Patients advocates for urgent policy changes to improve patient-centered care and the quality of life of seriously ill patients with kidney disease. It argues for the provision of supportive care by an interdisciplinary team led by nephrology clinicians to improve shared decision-making, advance care planning, pain and symptom management, the explicit offering of active medical management without dialysis as an option for patients who may not benefit from dialysis, and the removal by the Centers for Medicare & Medicaid Services and all other payors of financial and regulatory disincentives to quality supportive care, including hospice, for patients with or approaching kidney failure. It also emphasizes that all educational and accreditation programs for nephrology clinicians include kidney supportive care and its essential role in the care of patients with kidney disease.

Barriers and Facilitators to Active Medical Management without Dialysis.

Multiple studies document there are patients for whom hemodialysis can be predicted not to offer a survival advantage. The medical evidence also includes reports of strong, active medical management without dialysis programs in Australia, Canada, and the United Kingdom, yet the nephrology community in the United States has yet to provide to patients with end stage kidney disease an active medical management without dialysis option available throughout the country. This article reviews barriers and facilitators to starting such a program and offers recommendations for the components that have enabled international programs to be successful.

Derivation and validation of a prognostic model to predict mortality in patients with advanced chronic kidney disease.

BACKGROUND: Guiding patients with advanced chronic kidney disease (CKD) through advance care planning about future treatment obliges an assessment of prognosis. A patient-specific integrated model to predict mortality could inform shared decision-making for patients with CKD. METHODS: Patients with Stages 4 and 5 CKD from Massachusetts (749) and West Virginia (437) were prospectively evaluated for clinical parameters, functional status [Karnofsky Performance Score (KPS)] and their provider's response to the Surprise Question (SQ). A predictive model for 12-month mortality was derived with the Massachusetts cohort and then validated externally on the West Virginia cohort. Logistic regression was used to create the model, and the c-statistic and Hosmer-Lemeshow statistic were used to assess model discrimination and calibration, respectively. RESULTS: In the derivation cohort, the SQ, KPS and age were most predictive of 12-month mortality with odds ratios (ORs) [95% confidence interval (CI)] of 3.29 (1.87-5.78) for a 'No' response to the SQ, 2.09 (95% CI 1.19-3.66) for fair KPS and 1.41 (95% CI 1.15-1.74) per 10-year increase in age. The c-statistic for the 12-month mortality model for the derivation cohort was 0.80 (95% CI 0.75-0.84) and for the validation cohort was 0.74 (95% CI 0.66-0.83). CONCLUSIONS: Our integrated prognostic model for 12-month mortality in patients with advanced CKD had good discrimination and calibration. This model provides prognostic information to aid nephrologists in identifying and counseling advanced CKD patients with poor prognosis who are facing the decision to initiate dialysis or pursue medical management without dialysis.

Study protocol of coaching end-of-life palliative care for advanced heart failure patients and their family caregivers in rural appalachia: a randomized controlled trial.

BACKGROUND: Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers. Families are rarely prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options especially during the end stage. West Virginia (WV) has the highest rate of HF deaths in the U.S. where 14% of the population over 65 years have HF. Thus, there is a need to investigate a new family EOLPC intervention (FamPALcare), where nurses coach family-managed advanced HF care at home. METHODS: This study uses a randomized controlled trial (RCT) design stratified by gender to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care group outcomes (N = 72). Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF. Aim 2 is to assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials. Intervention group will receive routine standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. The intervention sessions involve coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions based on patients' preferences. Data are collected at baseline, 3, and 6 months. Recruitment is from sites affiliated with a large regional hospital in WV and community centers across the state. DISCUSSION: The outcomes of this clinical trial will result in new knowledge on coaching techniques for EOLPC and approaches to palliative and end-of-life rural home care. The HF population in WV will benefit from a reduction in suffering from the most common advanced HF symptoms, selecting their preferred EOLPC care options, determining their advance directives, and increasing skills and resources for advanced HF home care. The study will provide a long-term collaboration with rural community leaders, and collection of data on the implementation and research procedures for a subsequent large multi-site clinical trial of the FamPALcare intervention. Multidisciplinary students have opportunity to engage in the research process. TRIAL REGISTRATION: ClinicalTrials.gov NCT04153890, Registered on 4 November 2019.

Palliative Care Disincentives in CKD: Changing Policy to Improve CKD Care.

The dominant health delivery model for advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD) in the United States, which focuses on provision of dialysis, is ill-equipped to address many of the needs of seriously ill patients. Although palliative care may address some of these gaps in care, its integration into advanced CKD care has been suboptimal due to several health system barriers. These barriers include uneven access to specialty palliative care services, underdeveloped models of care for seriously ill patients with advanced CKD, and misaligned policy incentives. This article reviews policies that affect the delivery of palliative care for this population, discusses reforms that could address disincentives to palliative care, identifies quality measurement issues for palliative care for individuals with advanced CKD and ESRD, and considers potential pitfalls in the implementation of new models of integrated palliative care. Reforming health care delivery in ways that remove policy disincentives to palliative care for patients with advanced CKD and ESRD will fill a critical gap in care.

Providing supportive care to patients with kidney disease.

While it may never be "easy" to face these issues with patients, families, and caregivers, CSCKP hopes the best practices and tools outlined in this article, also available at www.kidney-supportivecare.org, will be helpful to renal professionals in providing quality supportive and end-of-life care to their patients. Encouraging and participating in shared decision making with patients and their loved ones can help all involved create an approach to care with which everyone is comfortable. The relationships formed through shared decision making will help keep the lines of communication open, which is essential as needs and prognosis change. This type of health care provider/patient relationship may also encourage patients to share more about their symptoms, as not all patients are forthcoming about their symptoms or pain, and thereby facilitate better assessment and treatment by clinicians. Working with a palliative care specialist may be necessary when symptoms become more challenging to manage and referral to hospice may need to be considered. Helping patients, families, and caregivers understand their options, assisting them in completing advance care plans, and ultimately respecting their wishes are all encompassed within the delivery of patient-centered care.

Executive summary of the KDIGO Controversies Conference on Supportive Care in Chronic Kidney Disease: developing a roadmap to improving quality care.

Patients with advanced chronic kidney disease (CKD) have a high burden of physical and psychosocial symptoms, poor outcomes, and high costs of care. Current paradigms of care for this highly vulnerable population are variable, prognostic and assessment tools are limited, and quality of care, particularly regarding conservative and palliative care, is suboptimal. The KDIGO Controversies Conference on Supportive Care in CKD reviewed the current state of knowledge in order to define a roadmap to guide clinical and research activities focused on improving the outcomes of people living with advanced CKD, including those on dialysis. An international group of multidisciplinary experts in CKD, palliative care, methodology, economics, and education identified the key issues related to palliative care in this population. The conference led to a working plan to address outstanding issues in this arena, and this executive summary serves as an output to guide future work, including the development of globally applicable guidelines.

Update on end-of-life care training during nephrology fellowship: a cross-sectional national survey of fellows.

BACKGROUND: Patients with end-stage renal disease have high mortality and symptom burden. Past studies demonstrated that nephrologists do not feel prepared to care for their patients at the end of life. We sought to characterize current palliative and end-of-life care education received during nephrology fellowship and compare this with data from 2003. STUDY DESIGN: Cross-sectional online survey of second-year nephrology trainees. Responses were compared to a similar survey in 2003. SETTING & PARTICIPANTS: 104 US nephrology fellowship programs in 2013. MEASUREMENTS: Quality of training in and attitudes toward end-of-life care and knowledge and preparedness to provide nephrology-specific end-of-life care. RESULTS: Of 204 fellows included for analysis (response rate, 65%), significantly more thought it was moderately to very important to learn to provide care at end of life in 2013 compared to 2003 (95% vs 54%; P<0.001). Nearly all (99%) fellows in both surveys believed physicians have a responsibility to help patients at end of life. Ranking of teaching quality during fellowship in all areas (mean, 4.1±0.8 on a scale of 0-5 [0, poor; 5, excellent]) and specific to end-of-life care (mean, 2.4±1.1) was unchanged from 2003, but knowledge of the annual gross mortality rate for dialysis patients was nominally worse in 2013 because only 57% versus 67% in 2003 answered correctly (P=0.05). To an open-ended question asking what would most improve fellows' end-of-life care education, the most common response was a required palliative medicine rotation during fellowship. LIMITATIONS: Assessments were based on fellows' subjective perceptions. CONCLUSIONS: Nephrology fellows increasingly believe they should learn to provide end-of-life care during fellowship. However, perceptions about the quality of this teaching have not improved during the past decade. Palliative care training should be integrated into nephrology fellowship curricula.

Ethical challenges with hemodialysis patients who lack decision-making capacity: behavioral issues, surrogate decision-makers, and end-of-life situations.

Hemodialysis (HD) is routinely offered to patients with end-stage renal disease in the United States who are ineligible for other renal replacement modalities. The frequency of HD among the US population is greater than all other countries, except Taiwan and Japan. In US, patients are often dialyzed irrespective of age, comorbidities, prognosis, or decision-making capacity. Determination of when patients can no longer dialyze is variable and can be dialysis-center specific. Determinants may be related to progressive comorbidities and frailty, mobility or access issues, patient self-determination, or an inability to tolerate the treatment safely for any number of reasons (e.g., hypotension, behavioral issues). Behavioral issues may impact the safety of not only patients themselves, but also those around them. In this article the authors present the case of an elderly patient on HD with progressive cognitive impairment and combative behavior placing him and others at risk of physical harm. The authors discuss the medical, ethical, legal, and psychosocial challenges to care of such patients who lack decision-making capacity with a focus on variable approaches by regions and culture. This manuscript provides recommendations and highlights resources to assist nephrologists, dialysis personnel, ethics consultants, and palliative medicine teams in managing such patients to resolve conflict.

An Integrative Review of the State of POLST Science: What Do We Know and Where Do We Go?

OBJECTIVES: POLST is widely used in the care of seriously ill patients to document decisions made during advance care planning (ACP) conversations as actionable medical orders. We conducted an integrative review of existing research to better understand associations between POLST use and key ACP outcomes as well as to identify directions for future research. DESIGN: Integrative review. SETTING AND PARTICIPANTS: Not applicable. METHODS: We queried PubMed and CINAHL databases using names of POLST programs to identify research on POLST. We abstracted study information and assessed study design quality. Study outcomes were categorized using the international ACP Outcomes Framework: Process, Action, Quality of Care, Health Status, and Healthcare Utilization. RESULTS: Of 94 POLST studies identified, 38 (40%) had at least a moderate level of study design quality and 15 (16%) included comparisons between POLST vs non-POLST patient groups. There was a significant difference between groups for 40 of 70 (57%) ACP outcomes. The highest proportion of significant outcomes was in Quality of Care (15 of 19 or 79%). In subdomain analyses of Quality of Care, POLST use was significantly associated with concordance between treatment and documentation (14 of 18 or 78%) and preferences concordant with documentation (1 of 1 or 100%). The Action outcome domain had the second highest positive rate among outcome domains; 9 of 12 (75%) Action outcomes were significant. Healthcare Utilization outcomes were the most frequently assessed and approximately half (16 of 35 or 46%) were significant. Health Status outcomes were not significant (0 of 4 or 0%), and no Process outcomes were identified. CONCLUSIONS AND IMPLICATIONS: Findings of this review indicate that POLST use is significantly associated with a Quality of Care and Action outcomes, albeit in nonrandomized studies. Future research on POLST should focus on prospective mixed methods studies and high-quality pragmatic trials that assess a broad range of person and health system-level outcomes.

Improving end-of-life care for ESRD patients: an initiative for professionals.

The Coalition for Supportive Care of Kidney Patients convened subject matter experts (SMEs) to assess the current state of palliative care for pre-dialysis (chronic kidney disease) and end-stage renal disease patients (stages 3-5). The SMEs noted that in the final month of life, dialysis patients have the higher percentage of hospitalizations, longer length of stay, greater intensive care admissions, and higher number of deaths in hospitals than cancer or heart failure patients, but use hospice only half as much as these two groups. The group identified a strategic approach and framework for achieving specific aims to improve palliative care education of health care providers, raise awareness of supportive care resources, define palliative care skills for nephrologists, and continue the implementation of shared decision-making for individualized patient-centered care.

Rethinking the Ethics of the Covid-19 Pandemic Lockdowns.

Public health responses to the Covid-19 pandemic included various measures to mitigate the spread of the virus. Among these, the most restrictive was a broad category referred to as "lockdowns." We argue that the reasoning offered in favor of extended lockdowns-those lasting several months or longer-did not adequately account for a host of countervailing considerations, including the impact on mental illness, education, employment, and marginalized communities as well as health, educational, and economic inequities. Furthermore, justifications offered for extended lockdowns set aside a basic tenet of public health ethics: restrictions on liberty and autonomy should be the least intrusive means of achieving the desired end. Since it is now clear that extended lockdowns cause severe harm to many vulnerable populations, the burden of proof is on those who would advocate for them, and there must be a much higher bar to implement an extended lockdown, with high-quality evidence that the benefit would substantially exceed its harm.

Implementation and Effectiveness of a Learning Collaborative to Improve Palliative Care for Seriously Ill Hemodialysis Patients.

BACKGROUND AND OBJECTIVES: Limited implementation of palliative care practices in hemodialysis may contribute to end-of-life care that is intensive and not patient centered. We determined whether a learning collaborative for hemodialysis center providers improved delivery of palliative care best practices. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Ten US hemodialysis centers participated in a pre-post study targeting seriously ill patients between April 2019 and September 2020. Three practices were prioritized: screening for serious illness, goals of care discussions, and use of a palliative dialysis care pathway. The collaborative educational bundle consisted of learning sessions, communication skills training, and implementation support. The primary outcome was change in the probability of complete advance care planning documentation among seriously ill patients. Health care utilization was a secondary outcome, and implementation outcomes of acceptability, adoption, feasibility, and penetration were assessed using mixed methods. RESULTS: One center dropped out due to the coronavirus disease 2019 pandemic. Among the remaining nine centers, 20% (273 of 1395) of patients were identified as seriously ill preimplementation, and 16% (203 of 1254) were identified as seriously ill postimplementation. From the preimplementation to postimplementation period, the adjusted probability of complete advance care planning documentation among seriously ill patients increased by 34.5 percentage points (95% confidence interval, 4.4 to 68.5). There was no difference in mortality or in utilization of palliative hemodialysis, hospice referral, or hemodialysis discontinuation. Screening for serious illness was widely adopted, and goals of care discussions were adopted with incomplete integration. There was limited adoption of a palliative dialysis care pathway. CONCLUSIONS: A learning collaborative for hemodialysis centers spanning the coronavirus disease 2019 pandemic was associated with adoption of serious illness screening and goals of care discussions as well as improved documentation of advance care planning for seriously ill patients. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Pathways Project: Kidney Supportive Care, NCT04125537.

Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure.

INTRODUCTION: Given the burdens of treatment and poor prognosis, older adults with kidney failure would benefit from improved decision making and palliative care to clarify goals, address symptoms, and reduce unwanted procedures. Best Case/Worst Case (BC/WC) is a communication tool that uses scenario planning to support patients' decision making. This article describes the protocol for a multisite, cluster randomised trial to test the effect of training nephrologists to use the BC/WC communication tool on patient receipt of palliative care, and quality of life and communication. METHODS AND ANALYSIS: We are enrolling attending nephrologists, at 10 study sites in the USA, who see outpatients with advanced chronic kidney disease considering dialysis. We aim to enrol 320 patients with an estimated glomerular filtration rate of ≤24 mL/min/1.73 m2 who are age 60 and older and have a predicted survival of 18 months or less. Nephrologists will be randomised in a 1:1 ratio to receive training to use the communication tool (intervention) at study initiation or after study completion (wait-list control). Patients in the intervention group will receive care from a nephrologist trained to use the BC/WC communication tool. Patients in the control group will receive usual care. Using chart review and surveys of patients and caregivers, we will test the efficacy of the BC/WC intervention with receipt of palliative care as the primary outcome. Secondary outcomes include intensity of treatment at the end of life, the effect of the intervention on quality of communication (QOC) between nephrologists and patients (using the QOC scale), the change in quality of life (using the Functional Assessment of Chronic Illness Therapy-Palliative Care scale) and receipt of dialysis. ETHICS AND DISSEMINATION: Approvals have been granted by the Institutional Review Board at the University of Wisconsin (ID: 2022-0193), with each study site ceding review to the primary IRB. All nephrologists will be consented and given a copy of the consent form. No patients or caregivers will be recruited or consented until their nephrology provider has chosen to participate in the study. Results will be disseminated via submission for publication in a peer-reviewed journal and at national meetings. TRIAL REGISTRATION NUMBER: NCT04466865.

When enough is enough: the nephrologist's responsibility in ordering dialysis treatments.

For more than 20 years, nephrologists have been reporting that they are increasingly being expected to dialyze patients whom they believe may receive little benefit from dialysis therapy. During this time, there has been substantial research about the outcomes of patients of differing ages and comorbid conditions requiring dialysis and the development of clinical practice guidelines for dialysis decision making based on research evidence, ethics, and the law. The importance of palliative medicine to the care of the patient throughout the continuum of kidney disease also has been recognized, and its application has been described. This article summarizes these advances and provides an approach for decision making and treatment for patients who are not likely to benefit from dialysis therapy.