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Completed

NCT Number: NCT04466865

A Communication Tool to Assist Older Adults Facing Dialysis Choices

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.

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Key information

Conditions

Palliative Care Behavior Chronic Disease Communication Death Decision Aid Decision Making Decision Support Techniques Dialysis Disease Attributes End of Life End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Late-Stage Renal Disease Life-Supporting Treatments Male Urogenital Diseases Nephrologists Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Dialysis Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Denver, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: from enrollment up to 12 months, data collected up to 2 years

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

Secondary outcomes

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

    Time frame: From enrollment for up to 2 years

    Number of patients with receipt of any palliative care as determined by chart review or patient or caregiver report during 2-year follow up.

  2. Patient-reported health-related quality of life

    Time frame: Every 3 months for up to 2 years after enrollment

    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.

  3. Patient-reported health-related quality of life

    Time frame: Every 3 months for up to 2 years after enrollment

    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.

  4. Patient-reported health-related quality of life

    Time frame: Every 3 months for up to 2 years after enrollment

    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.

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

    Time frame: 48 hours after enrollment

    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.

  6. Patient-reported general quality of communication (QOC) received from study nephrologist

    Time frame: 48 hours after enrollment

    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.

  7. Patient-reported quality of end-of-life communication (QOC) received from study nephrologist

    Time frame: 48 hours after enrollment

    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.

  8. Hospice enrollment during 2-year follow up as determined by chart review or report by patient or caregiver

    Time frame: From enrollment for up to 2 years

    Number of patients with documentation of hospice enrollment as determined by chart review and patient or caregiver report during 2-year follow up.

  9. Documentation of new advance care planning during 2-year follow up as determined by chart review or report by patient or caregiver

    Time frame: From enrollment for up to 2 years

    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.

  10. Treatment intensity at the end of life review as determined by chart review or report by patient or caregiver

    Time frame: Within 30 days of death

    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.

  11. Surgical treatment intensity at the end of life as determined by chart review or report by patient or caregiver

    Time frame: Within 30 days of death

    Number of patients who had one or more surgical procedure within 30 day as determined by chart review or patient or caregiver report.

  12. Initiation of dialysis as determined by chart review or report by patient or caregiver

    Time frame: From enrollment for up to 2 years

    Number of patients initiating dialysis as determined by chart review or patient or caregiver report.

  13. Time to on-study death

    Time frame: From enrollment for up to 2 years

    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.

  14. Caregiver-reported quality of dying and death

    Time frame: 3 months after 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.

  15. Caregiver-reported health related quality of life

    Time frame: Every 3 months for up to 2 years after enrollment

    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.

  16. Caregiver-reported general quality of communication (QOC) received from study nephrologist

    Time frame: Within 48 hours after enrollment

    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.

  17. Caregiver-reported quality of end-of-life communication (QOC) received from study nephrologist

    Time frame: Within 48 hours after enrollment

    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.

  18. Treatment intensity at the end of life as determined by chart review or report by patient or caregiver

    Time frame: Within 30 days before death

    Number of patients with 1 or more ICU admission within 30 days of death.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2020
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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