An interventional study of Best Case/Worst Case communication tool training in Palliative Care, Kidney Failure, Chronic and Decision Making, sponsored by University of Wisconsin, Madison. Completed at 11 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research
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.
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 261 are open to participants now.
This study's enrollment of 407 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
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.
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.
Time frame: from enrollment up to 12 months, data collected up to 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 30 days before death
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — A de-identified data set from this project will be stored in the Palliative Care Research Cooperative Group (PCRC) De-identified Data Repository (DiDR).
Supporting information: Study protocol, Sap, Icf, Analytic code
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University of Wisconsin, Madison