A Communication Tool to Assist Older Adults Facing Dialysis Choices

Best Case/Worst Case: A Multisite Randomized Clinical Trial of Scenario Planning for Patients With End-Stage Kidney Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Diseases; Kidney Failure, Chronic; Communication; End-Stage Renal Disease; Palliative Care; End of Life; Dialysis; Renal Dialysis; Decision Making; Decision Aid; Decision Support Techniques; Nephrologists; Late-Stage Renal Disease; Life-Supporting Treatments
• Intervention / Treatment: Other: Best Case/Worst Case communication tool training

Detailed Description

This study will test the effect of the Best Case/Worst Case intervention 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). This multi-site cluster randomized trial will enroll 320 participants who are making a dialysis initiation decision and receive care from a nephrologist trained to use the Best Case/Worst Case tool, or care from a nephrologist who has not been trained to use this tool (usual care). Randomly assigned nephrologists within each site will receive the intervention or waitlist control (upon study completion). Participants will be on follow up for up to two years after study enrollment via regular surveys and chart review. This study has three aims:

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.

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 173364
      • University of Colorado, Denver
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10027
      • Columbia University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh
  • Vermont
    • Burlington, Vermont, United States, 05405
      • Department of Medicine, University of Vermont
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of palliative care during 2-year follow up as determined by chart review or report by patient or caregiver	Number of patients with receipt of any palliative care as determined by chart review or patient or caregiver report during 2-year follow up.	From enrollment for up to 2 years
Patient-reported health-related quality of life	Patient-reported health related quality of life will be measured using the 46-item Functional Assessment of Chronic Illness Therapy-Palliative Care Version 4 (FACIT-Pal); the investigators will compare the average score and average change (slope) in health-related quality of life over time, using the total score at last follow up. Possible scores for the FACIT-Pal total score range from 0-184. Higher scores indicate better quality of life.	Every 3 months for up to 2 years after enrollment
Patient-reported health-related quality of life	Patient-reported health related quality of life will be measured using the 27-item Functional Assessment of Cancer Therapy - General (FACT-G) scale (used here in non-cancer patients as part of the FACIT-Pal instrument). Possible scores for the FACT-G total score range from 0-108. Higher scores indicate better quality of life.	Every 3 months for up to 2 years after enrollment
Patient-reported health-related quality of life	Patient-reported health related quality of life will be measured using the 19-item FACIT-Pal palliative care subscale (PalS). Possible scores for the PalS range from 0-76. Higher scores indicate better quality of life.	Every 3 months for up to 2 years after enrollment
Patient-reported quality of communication (QOC) received from study nephrologist	Patient-reported general quality of communication will be measured using the 19-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. The average composite score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.	48 hours after enrollment
Patient-reported general quality of communication (QOC) received from study nephrologist	Patient-reported general quality of communication will be measured using the 6-item general communication subscale of the 19-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. The average item score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.	48 hours after enrollment
Patient-reported quality of end-of-life communication (QOC) received from study nephrologist	Patient-reported quality of end-of-life communication will be measured using 7-item end-of-life communication subscale of the 19-item Quality of Communication scale. The QOC is a validated self-report instrument. The average item score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.	48 hours after enrollment
Hospice enrollment during 2-year follow up as determined by chart review or report by patient or caregiver	Number of patients with documentation of hospice enrollment as determined by chart review and patient or caregiver report during 2-year follow up.	From enrollment for up to 2 years
Documentation of new advance care planning during 2-year follow up as determined by chart review or report by patient or caregiver	Number of patients with new documentation of advance care planning as determined by chart review or patient or caregiver report during 2-year follow up.	From enrollment for up to 2 years
Treatment intensity at the end of life review as determined by chart review or report by patient or caregiver	Number of patients with one or more of the following within 30 days of death: ER visit, ICU stay or hospitalization as determined by chart review or patient or caregiver report.	Within 30 days of death
Surgical treatment intensity at the end of life as determined by chart review or report by patient or caregiver	Number of patients who had one or more surgical procedure within 30 day as determined by chart review or patient or caregiver report.	Within 30 days of death
Initiation of dialysis as determined by chart review or report by patient or caregiver	Number of patients initiating dialysis as determined by chart review or patient or caregiver report.	From enrollment for up to 2 years
Time to on-study death	Time, in six month intervals, from baseline to 2 years. The Kaplan-Meier estimate reports the percentage of participants who experience death within 2 years from randomization. Participant death will be ascertained through medical record review and caregiver report.	From enrollment for up to 2 years
Caregiver-reported quality of dying and death	Quality of dying and death as perceived by the patient's caregiver will be measured using the Quality of Death and Dying (QODD) survey that asks about the patient's final 30 days of life. Possible scores on this measure range from 0 to 100 and higher scores indicate higher quality of dying and death.	3 months after death
Caregiver-reported health related quality of life	Caregiver-reported health related quality of life will be measured using the Cambridge Palliative Audit Schedule (CAMPAS-R). Possible scores on this survey range from 0-100 and higher scores indicate greater symptomology.	Every 3 months for up to 2 years after enrollment
Caregiver-reported general quality of communication (QOC) received from study nephrologist	Caregiver-reported general quality of communication will be measured using the 6-item general communication subscale of the 19-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. Possible scores on this subscale range from 0-60. Higher scores indicate higher perceived quality of communication.	Within 48 hours after enrollment
Caregiver-reported quality of end-of-life communication (QOC) received from study nephrologist	Caregiver-reported quality of end-of-life communication will be measured using 7-item end-of-life communication subscale of the 19-item Quality of Communication scale. The QOC is a validated self-report instrument. Possible scores on this subscale range from 0-70. Higher scores indicate higher perceived quality of communication.	Within 48 hours after enrollment
Treatment intensity at the end of life as determined by chart review or report by patient or caregiver	Number of patients with 1 or more ICU admission within 30 days of death.	Within 30 days before death

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Johns Hopkins University; University of Colorado, Denver; Northwestern University; Columbia University; Icahn School of Medicine at Mount Sinai; University of Pittsburgh; National Institute on Aging (NIA); Medical College of Wisconsin; University of Washington; University of Vermont; West Virginia University; The Palliative Care Research Cooperative Group
• Investigators: Principal Investigator: Jean Kutner, MD, University of Colorado, Denver; Principal Investigator: 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: Daniel Lam, MD, University of Washington; Principal Investigator: Dawn Wolfgram, MD, Medical College Of Wisconsin; Principal Investigator: Jeniann Yi, MD, University of Colorado, Denver; Principal Investigator: Alvin Moss, MD, West Virginia University; Principal Investigator: Maya Rao, MD, Columbia University; Principal Investigator: Tamara Isakova, MD, MMSc, Northwestern University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Death; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 2022-0193; SMPH/SURGERY (Other Identifier: UW Madison); A539750 (Other Identifier: UW Madison); 1R01AG065365-01 (U.S. NIH Grant/Contract); Protocol Version 5/31/2022 (Other Identifier: UW Madison); 2019-1074 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified data set from this project will be stored in the Palliative Care Research Cooperative Group (PCRC) De-identified Data Repository (DiDR).
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No