A Communication Tool to Assist Older Adults Facing Dialysis Choices
NCT ID: NCT04466865
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
407 participants
INTERVENTIONAL
2020-11-02
2025-11-10
Brief Summary
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The intervention will be tested with 320 older adults who have end-stage renal disease (ESRD) and are receiving care from a nephrologist enrolled in the study. Randomly assigned nephrologists within each site will receive the intervention (training to use the BC/WC tool) or to be in the waitlist control, meaning that they will not be offered BC/WC training until the end of the study, when all participants have been enrolled. Participants will be on follow up with surveys and chart review for up to two years after study enrollment. Caregivers will also be invited to participate and complete surveys.
Detailed Description
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Aim 1: To test the effect of the Best Case/Worst Case intervention on (1) receipt of palliative care and (2) intensity of treatment at the end of life for older patients with ESRD. Chart reviews will be used to determine whether participants have received at least one outpatient or inpatient palliative care consultation within 12 months of enrollment in the study. These consultations must be clearly marked as palliative care, provided by a clinician with palliative care training and have documented discussion of goals clarification, advance care planning, symptom management, coping, spiritual needs, or end-of-life care. To measure intensity of treatment received at the end of life, it will be determined whether participants have had an ICU admission within 30 days of death as a primary outcome and ICU admission, emergency room (ER) visit, or hospital admission within 30 days of death as a composite secondary outcome.
Aim 2: To test the effect of the Best Case/Worst Case intervention on quality of life. The primary outcome for Aim 2 is quality of life as measured by the Functional Assessment of Chronic Illness Therapy -Palliative Care (FACIT-Pal Version 4) at baseline, and every three months for up to 2 years after study enrollment. The hypothesis is that the overall quality of life will decline over time as participants become more infirm. The average change in health-related quality of life over time which has been shown to decline less with the receipt of concurrent palliative care will be compared.
Aim 3: To test the effect of the Best Case/Worst Case intervention on the quality of communication. To evaluate participant's assessment of nephrologist communication, the Quality of Communication (QOC) scale developed by Randy Curtis will be used. Unlike other measurements of physician communication that have high ceiling effects and limited ability to measure change, the QOC includes 7 items specific to end-of-life communication, which, if not performed by the clinician, are scored as zero. This will allow us to discriminate between quality of communication attributable to participant satisfaction (with high ceiling effects) versus content.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Best Case/Worst Case communication tool
The participant's enrolled nephrologist will have completed training on the Best Case/Worst Case communication tool and will be encouraged to use it with the participant.
Best Case/Worst Case communication tool training
The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of kidney disease. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning the intervention is designed to lead to a discussion of participants preferences and consideration of outcomes.
The nephrologist verbally describes the "best case," "worst case," and "most likely" outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The nephrologist also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences.
Usual Care
Usual care conversations are typically focused on mode and timing of dialysis, management of electrolytes and scheduling of laboratory testing. Conservative management or a treatment option of "no dialysis" is rarely mentioned.
No interventions assigned to this group
Interventions
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Best Case/Worst Case communication tool training
The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of kidney disease. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning the intervention is designed to lead to a discussion of participants preferences and consideration of outcomes.
The nephrologist verbally describes the "best case," "worst case," and "most likely" outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The nephrologist also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences.
Eligibility Criteria
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Inclusion Criteria
* Not currently on dialysis (participants are eligible if they have had intermittent dialysis in the past or have dialysis access in place but are not currently on dialysis)
* Participants must meet one or more of the following criteria: age greater than 80, evidence from the medical record that the patient has comorbid illness such that the modified Charlson score is 4 or greater, or a negative response to the standard "Surprise Question" ("Would you be surprised if this patient died in the next year?") from the participant's nephrologist.
Exclusion Criteria
* Lack decision-making capacity
* Do not speak English
60 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of Pittsburgh
OTHER
University of Vermont
OTHER
Johns Hopkins University
OTHER
University of Colorado, Denver
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
University of Washington
OTHER
West Virginia University
OTHER
Columbia University
OTHER
Medical College of Wisconsin
OTHER
The Palliative Care Research Cooperative Group
UNKNOWN
Northwestern University
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Margaret L Schwarze, MD, MPP, FACS
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Amar Bansal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Katharine Cheung, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Deidra Crews, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Katie Colborn, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Holly Koncicki, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Jean Kutner, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Daniel Lam, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Alvin Moss, MD
Role: PRINCIPAL_INVESTIGATOR
West Virginia University
Maya Rao, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Dawn Wolfgram, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Jeniann Yi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Tamara Isakova, MD, MMSc
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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University of Colorado, Denver
Denver, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Columbia University
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Department of Medicine, University of Vermont
Burlington, Vermont, United States
University of Washington
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Schell JO, Patel UD, Steinhauser KE, Ammarell N, Tulsky JA. Discussions of the kidney disease trajectory by elderly patients and nephrologists: a qualitative study. Am J Kidney Dis. 2012 Apr;59(4):495-503. doi: 10.1053/j.ajkd.2011.11.023. Epub 2012 Jan 4.
Ladin K, Lin N, Hahn E, Zhang G, Koch-Weser S, Weiner DE. Engagement in decision-making and patient satisfaction: a qualitative study of older patients' perceptions of dialysis initiation and modality decisions. Nephrol Dial Transplant. 2017 Aug 1;32(8):1394-1401. doi: 10.1093/ndt/gfw307.
Haug K, Buffington A, Zelenski A, Hanlon BM, Stalter L, Kwekkeboom KL, Rathouz P, Bansal AD, Cheung K, Crews D, Frazier R, Koncicki H, Lam D, Moss A, Rao M, Wolfgram DF, Yi J, Brill C, Kendrick R, Campbell TC, Jhagroo R, Schwarze M. Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure. BMJ Open. 2022 Nov 3;12(11):e067258. doi: 10.1136/bmjopen-2022-067258.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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A539750
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/SURGERY
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 1/23/2025
Identifier Type: OTHER
Identifier Source: secondary_id
2019-1074
Identifier Type: OTHER
Identifier Source: secondary_id
2022-0193
Identifier Type: -
Identifier Source: org_study_id