A Patient Decision Aid About Conservative Kidney Management in Advanced Kidney Disease: A Randomized Pilot Trial.

RATIONALE & OBJECTIVE: Available decision aids for patients about treatment of advanced chronic kidney disease (CKD) often lack information on conservative kidney management (CKM). We assessed the feasibility and acceptability of a decision aid on CKM among patients with advanced CKD and their family members. STUDY DESIGN: Randomized pilot trial. SETTING & PARTICIPANTS: Patients aged≥75 years with stage 4 or 5 CKD and their family members at 4 medical centers in the greater Seattle area between August 2020 and December 2021. INTERVENTIONS: Usual care with or without a decision aid on CKM. OUTCOME: Acceptability was assessed by attrition rates between the initial study visit (T1) and the 3-month follow-up evaluation (T3). The primary outcome and measure of feasibility was the proportion of participants who discussed CKM with a health care provider between T1 and T3. RESULTS: We randomized 92 patients of whom 86 (55.8% male; age 82±6 years; 82.6% White) completed T1-42 in the usual care arm and 44 in the usual care plus decision aid arm-and 56 family members of whom 53 (18.9% male; age 71±11 years; 86.8% White) completed T1-20 in usual care arm and 33 in the usual care plus decisions aid arm. The attrition rates were 21% versus 21% (P=1.0) for patients, and 10% versus 18% (P=0.46) for family members in the usual care versus usual care plus decisions aid arms. Receipt of the decision aid significantly increased discussion of CKM with a health care provider for patients (26.4% vs 3.0%, P=0.007) and family members (26.9% vs 0, P=0.02). LIMITATIONS: Possible limited generalizability because participants were a relatively homogenous group. The decision aid focuses on CKM and may be less applicable to those with limited knowledge of kidney replacement therapies. CONCLUSIONS: A CKM decision aid was feasible and acceptable, and increased discussion of this treatment option with health care providers. This aid may serve as a useful adjunct to the currently available educational tools on treatments for advanced CKD. FUNDING: Grant from a not-for-profit entity (National Palliative Care Research Center). TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT04919941.

Using Human-Centered Design Principles to Create a Decision Aid on Conservative Kidney Management for Advanced Kidney Disease.

Background: Most patients are unaware of approaches to treating advanced chronic kidney disease (CKD) other than dialysis. Methods: We developed a dedicated decision aid on conservative kidney management using human-centered design principles in three phases: (1) discovery: engagement of informants to understand their needs and preferences; (2) design: multiple rapid cycles of ideation, prototyping, and testing of a decision aid with a small group of informants; and (3) implementation: testing the decision aid in real-world settings with attention to how the decision aid can be further refined. Informants included a national patient advisory committee on kidney diseases, 50 patients with stage 4 or 5 CKD and 35 of their family members, and 16 clinicians recruited from the greater Seattle area between June 2019 and September 2021. Results: Findings from the discovery phase informed an initial prototype of the decision aid, which included five sections: a description of kidney disease and its signs and symptoms, an overview of conservative kidney management and the kinds of supports provided, self-reflection exercises to elicit patients' values and goals, the pros and cons of conservative kidney management, and the option of changing one's mind about conservative kidney management. The prototype underwent several rounds of iteration during its design phase, which resulted in the addition of an introductory section describing the intended audience and more detailed information in other sections. Findings from its implementation phase led to the addition of examples of common questions that patients and family members had about conservative kidney management and a final section on other related educational resources. Conclusions: Human-centered design principles supported a systematic and collaborative approach between researchers, patients, family members, and clinicians for developing a decision aid on conservative kidney management.

The VA Life-Sustaining Treatment Decisions Initiative: A qualitative analysis of veterans with advanced kidney disease.

BACKGROUND: Documentation of patients' goals of care is integral to promoting goal-concordant care. In 2017, the Department of Veterans Affairs (VA) launched a system-wide initiative to standardize documentation of patients' preferences for life-sustaining treatments (LST) and related goals-of-care conversations (GoCC) that included using a note template in its national electronic medical record system. We describe implementation of the LST note based on documentation in the medical records of patients with advanced kidney disease, a group that has traditionally experienced highly intensive patterns of care. METHODS: We performed a qualitative analysis of documentation in the VA electronic medical record for a national random sample of 500 adults with advanced kidney disease for whom at least one LST note was completed between July 2018 and March 2019 to identify prominent themes pertaining to the content and context of LST notes. RESULTS: During the observation period, a total of 723 (mean 1.5, range 1-6) LST notes were completed for this cohort. Two themes emerged from the analysis: (1) Reactive approach: LST notes were largely completed in response to medical crises, in which they focused on short-term goals and preferences rather than patients' broader health and goals, or certain clinical encounters designated by the initiative as "triggering events" for LST note completion; (2) Practitioner-driven: Documentation suggested that practitioners would attempt to engage patients/surrogates in GoCC to lay out treatment options in order to move care forward, but patients/surrogates sometimes appeared reluctant to engage in GoCC and had difficulty communicating in ways that practitioners could understand. CONCLUSIONS: Standardized documentation of patients' treatment preferences and related GoCC was used to inform in-the-moment decision-making during acute illness and certain junctures in care. There is opportunity to expand standardized documentation practices and related GoCC to address patients'/surrogates' broader health concerns and goals and to enhance their engagement in these processes.

Long-term Outcomes Among Patients With Advanced Kidney Disease Who Forgo Maintenance Dialysis: A Systematic Review.

Importance: An understanding of the long-term outcomes of patients with advanced chronic kidney disease not treated with maintenance dialysis is needed to improve shared decision-making and care practices for this population. Objective: To evaluate survival, use of health care resources, changes in quality of life, and end-of-life care of patients with advanced kidney disease who forgo dialysis. Evidence Review: MEDLINE, Embase (Excerpta Medica Database), and CINAHL (Cumulative Index of Nursing and Allied Health Literature) were searched from inception through December 3, 2021, for all English language longitudinal studies of adults in whom there was an explicit decision not to pursue maintenance dialysis. Two investigators independently reviewed all studies and selected those reporting survival, use of health care resources, changes in quality of life, or end-of-life care during follow-up. Studies of patients who initiated and then discontinued maintenance dialysis and patients in whom it was not clear that there was an explicit decision to forgo dialysis were excluded. One author abstracted all study data, of which 12% was independently adjudicated by a second author (<1% error rate). Findings: Forty-one cohort studies comprising 5102 patients (range, 11-812 patients) were included in this systematic review (5%-99% men; mean age range, 60-87 years). Substantial heterogeneity in study designs and measures used to report outcomes limited comparability across studies. Median survival of cohorts ranged from 1 to 41 months as measured from a baseline mean estimated glomerular filtration rate ranging from 7 to 19 mL/min/1.73 m2. Patients generally experienced 1 to 2 hospital admissions, 6 to 16 in-hospital days, 7 to 8 clinic visits, and 2 emergency department visits per person-year. During an observation period of 8 to 24 months, mental well-being improved, and physical well-being and overall quality of life were largely stable until late in the illness course. Among patients who died during follow-up, 20% to 76% had enrolled in hospice, 27% to 68% died in a hospital setting and 12% to 71% died at home; 57% to 76% were hospitalized, and 4% to 47% received an invasive procedure during the final month of life. Conclusions and Relevance: Many patients who do not pursue dialysis survived several years and experienced sustained quality of life until late in the illness course. Nonetheless, use of acute care services was common and intensity of end-of-life care highly variable across cohorts. These findings suggest that consistent approaches to the study of conservative kidney management are needed to enhance the generalizability of findings and develop models of care that optimize outcomes among conservatively managed patients.

Perspectives on Conservative Care in Advanced Kidney Disease: A Qualitative Study of US Patients and Family Members.

RATIONALE & OBJECTIVE: Little is known about perceptions of conservative care among patients with advanced kidney disease in the United States. STUDY DESIGN: Qualitative study using cognitive interviewing about attitudes regarding conservative care using decision aids on treatments for advanced kidney disease developed outside the United States. SETTING & PARTICIPANTS: 14 patients 75 years or older with advanced kidney disease, defined as estimated glomerular filtration rate≤20mL/min/1.73m2 and not receiving maintenance dialysis, and 6 of their family members. ANALYTICAL APPROACH: Thematic analysis of participants' reactions to descriptions of conservative care taken from various clinical care decision aids. RESULTS: Participants were mostly White (n=15) and had at least some college education (n=16). Four themes emerged from analysis of interviews: (1) core elements of conservative care: aspects of conservative care that were appealing to participants included a whole-person, team-based, and structured approach to care that focused on symptom management, maintaining current lifestyle, and managing health setbacks; (2) importance of how conservative care is framed: participants were more receptive to conservative care when this was framed as an active rather than passive treatment approach and were receptive to statements of uncertainty about future course of illness and prognosis; (3) an explicit approach to shared decision making: participants believed decisions about conservative care and dialysis should address considerations about risk and benefits of treatment options, family and clinician perspectives, and patients' goals, values, and preferences; and (4) relationship between conservative care and dialysis: although conservative care models outside the United States are generally intended to serve as an alternative to dialysis, participants' comments implied that they did not see conservative care and dialysis as mutually exclusive. LIMITATIONS: Themes identified may not generalize to the broader population of US patients with advanced kidney disease and their family members. CONCLUSIONS: Participants were favorably disposed to a whole-person multidisciplinary approach to conservative care, especially when framed as an active treatment approach. Models of conservative care excluding the possibility of dialysis were less embraced, suggesting that current models will require adaptation to meet the needs of US patients and their families.

Adaptation of Lean Six Sigma Methodologies for the Evaluation of Veterans Choice Program at 3 Urban Veterans Affairs Medical Centers.

OBJECTIVE: The Veterans Health Administration (VHA) is adapting to meet the changing needs of our Veterans. VHA leaders are promoting quality improvement strategies including Lean Six Sigma (LSS). This study used LSS tools to evaluate the Veterans Choice Program (VCP), a program that aims to improve access to health care services for eligible Veterans by expanding health care options to non-VHA providers. RESEARCH DESIGN: LSS was utilized to assess the current process and efficiency patterns of the VCP at 3 VHA Medical Centers. LSS techniques were used to assess data obtained through semistructured interviews with Veterans, staff, and providers to describe and evaluate the VCP process by identifying wastes and defects. RESULTS: The LSS methodology facilitated the process of targeting priorities for improvement and constructing suggestions to close identified gaps and inefficiencies. Identified key process wastes included inefficient exchange of clinical information between stakeholders in and outside of the VHA; poor dissemination of VCP programmatic information; shortages of VCP-participating providers; duplication of appointments; declines in care coordination; and lack of program adaptability to local processes. Recommendations for improvement were formulated using LSS. CONCLUSIONS: This evaluation illustrates how LSS can be utilized to assess a nationally mandated health care program. By focusing on stakeholder, staff, and Veteran perspectives, process defects in the VCP were identified and improvement recommendations were made. However, the current LSS language used is not intuitive in health care and similar applications of LSS may consider using new language and goals adapted specifically for health care.