A Communication Tool to Assist Older Adults Facing Dialysis Choices

NCT04466865 | Completed DMC

• 6 other identifiers: 2022-01931R01AG065365-01A539750SMPH/SURGERYProtocol Version 1/23/20252019-1074
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to test the effect of the "Best Case/Worse Case" (BC/WC) communication tool on receipt of palliative care and intensity of treatment at the end of life, quality of life, and quality of communication for older patients with end-stage renal disease (ESRD) receiving outpatient care at ten nephrology clinics. The intervention was developed and tested with acute care surgical patients at the University of Wisconsin (UW) and is now being testing to see if the intervention will work in a different setting. 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.

Conditions

Kidney Failure, Chronic; Decision Making; Decision Support Techniques; Renal Dialysis; Kidney Diseases; Life-Supporting Treatments; Nephrologists; Decision Aid; End of Life; End-Stage Renal Disease; Late-Stage Renal Disease; Communication; Palliative Care; Dialysis

Outcome Measures

Primary Outcomes (1)

• Receipt of palliative care consult within 12 months of study enrollment, as determined by chart review or report by patient or caregiver

  Number of patients with 1 or more palliative care consults within 12 months of study enrollment.

  from enrollment up to 12 months, data collected up to 2 years

Secondary Outcomes (18)

• Receipt of palliative care during 2-year follow up as determined by chart review or report by patient or caregiver

  From enrollment for up to 2 years

• Patient-reported health-related quality of life

  Every 3 months for up to 2 years after enrollment

• Patient-reported health-related quality of life

  Every 3 months for up to 2 years after enrollment

• Patient-reported health-related quality of life

  Every 3 months for up to 2 years after enrollment

• Patient-reported quality of communication (QOC) received from study nephrologist

  48 hours after enrollment

Study Arms (2)

Best Case/Worst Case communication tool

EXPERIMENTAL

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.

Other: Best Case/Worst Case communication tool training

Usual Care

NO INTERVENTION

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.

Interventions

Best Case/Worst Case communication tool training OTHER

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.

Best Case/Worst Case communication tool

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Estimated glomerular filtration rate (eGFR) of less than or equal to 24
• 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.

You may not qualify if:

• Currently on dialysis
• Lack decision-making capacity
• Do not speak English

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator
• University of Pittsburgh: collaborator
• University of Vermont: collaborator
• Johns Hopkins University: collaborator
• University of Colorado, Denver: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• University of Washington: collaborator
• West Virginia University: collaborator
• Columbia University: collaborator
• Medical College of Wisconsin: collaborator
• The Palliative Care Research Cooperative Group: collaborator
• Northwestern University: collaborator

Study Sites (11)

University of Colorado, Denver

Denver, Colorado, 173364, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Department of Medicine, University of Vermont

Burlington, Vermont, 05405, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• 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.

  PMID: 22221483 BACKGROUND

• 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.

  PMID: 27576590 BACKGROUND

• 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.

  PMID: 36328383 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Kidney Diseases; Death; Communication

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Margaret L Schwarze, MD, MPP, FACS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Amar Bansal, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Katharine Cheung, MD, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

• Deidra Crews, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Katie Colborn, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Holly Koncicki, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Jean Kutner, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Daniel Lam, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Alvin Moss, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

• Maya Rao, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Dawn Wolfgram, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Jeniann Yi, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Tamara Isakova, MD, MMSc

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: November 2, 2020
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: One year after study completion or two months after initial manuscript has been accepted for publication (whichever comes first), UW will securely transfer a de-identified dataset to the PCRC Data Repository.
• Access Criteria: Investigators may request access to de-identified study data for secondary analyses using the PCRC Data Repository webform. Requests must include a summary of the following: research questions, objectives, hypotheses, statistical analysis plan, and project timeline. Requestors must provide a list of specific variables they would like included in the secondary data set. Each request must also include a data security plan and explanation of how the data will be stored and who will have access to it. The PCRC staff and UW PI will review all requests assessing the scientific integrity, feasibility and analytic rigor.

Locations

US (11)