Palliative CareNCT04466865
A Communication Tool to Assist Older Adults Facing Dialysis Choices
A study testing Best Case/Worst Case communication tool training in people with Palliative Care and Kidney Failure, Chronic, run by University of Wisconsin, Madison at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Palliative Care, Kidney Failure, Chronic, Decision Making
- What is being tested?
- Best Case/Worst Case communication tool training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 11 sitesUnited States
- Study dates
- 2 Nov 2020to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Currently on dialysis
- Lack decision-making capacity
- Do not speak English
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan
Ann Arbor, Michigan, 48105
Johns Hopkins University
Baltimore, Maryland, 21287
Department of Medicine, University of Vermont
Burlington, Vermont, 05405
Northwestern University
Chicago, Illinois, 60611
University of Colorado, Denver
Denver, Colorado, 173364
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
West Virginia University
Morgantown, West Virginia, 26506
Columbia University
New York, New York, 10027
Mount Sinai School of Medicine
New York, New York, 10029
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
University of Washington
Seattle, Washington, 98195
About this study
Official title: 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.
Read the 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.
- Conditions
- Palliative Care, Kidney Failure, Chronic, Decision Making, Decision Support Techniques, Renal Dialysis, Dialysis
- Being tested
- Best Case/Worst Case communication tool training
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases, Death, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Case/Worst Case communication tool trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Number of patients with receipt of any palliative care as determined by chart review or patient or caregiver report during 2-year follow up.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 days before death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start2 Nov 2020
- Primary completion10 Nov 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Pittsburgh, University of Vermont, Johns Hopkins University, University of Colorado, Denver, Icahn School of Medicine at Mount Sinai, University of Washington, West Virginia University, Columbia University, Medical College of Wisconsin, Palliative Care Research Cooperative Group, Northwestern University
- Responsible party
- Sponsor
- Investigators
- Margaret L Schwarze, MD, MPP, FACS, Principal investigator, University of Wisconsin, MadisonAmar Bansal, MD, Principal investigator, University of PittsburghKatharine Cheung, MD, PhD, Principal investigator, University of VermontDeidra Crews, MD, Principal investigator, Johns Hopkins UniversityKatie Colborn, PhD, Principal investigator, University of Colorado, DenverHolly Koncicki, MD, Principal investigator, Icahn School of Medicine at Mount SinaiJean Kutner, MD, Principal investigator, University of Colorado, DenverDaniel Lam, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466865
- Sponsor's protocol ID
- 2022-0193
- Other IDs
- 1R01AG065365-01, A539750, SMPH/SURGERY, Protocol Version 1/23/2025, 2019-1074
- Status last verified
- Apr 2026
- First submitted
- 7 Jul 2020
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
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.
PubMed 22221483Ladin 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.
PubMed 27576590Stalter LN, Hanlon BM, Bushaw KJ, Nitkowski J, Buffington A, Cheung KL, Zelenski AB, Kwekkeboom K, Bansal AD, Candice Crews D, Koncicki HM, Lam D, Moss AH, Rao MK, Felicity Wolfgram D, Yi J, Brill C, Isakova T, Schwarze ML. Best Case/Worst Case: A Multisite Randomized Trial of Scenario Planning for Patients With Late-Stage Kidney Disease. J Am Geriatr Soc. 2026 Sep 5. doi: 10.1111/jgs.70695. Online ahead of print.
PubMed 42698358Haug 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.
PubMed 36328383
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Case/Worst Case: A Multisite Randomized Clinical Trial of Scenario Planning for Patients With End-Stage Kidney Disease
- ClinicalTrials.gov ID
- NCT04466865
- Acronym / sponsor ID
- 2022-0193
- Conditions
- Palliative Care, Kidney Failure, Chronic, Decision Making, Decision Support Techniques, Renal Dialysis, Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Pittsburgh, University of Vermont, Johns Hopkins University, University of Colorado, Denver, Icahn School of Medicine at Mount Sinai, University of Washington, West Virginia University, Columbia University, Medical College of Wisconsin, Palliative Care Research Cooperative Group, Northwestern University
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Case/Worst Case communication tool | Experimental | Other: Best Case/Worst Case communication tool trainingThe 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. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Currently on dialysis
- Lack decision-making capacity
- Do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Case/Worst Case communication tool trainingThe 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. | Other | Best Case/Worst Case communication tool |
Primary outcome
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.
18 secondary outcomes
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
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
Time frame: Every 3 months for up to 2 years after enrollment
Patient-reported health-related 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
Time frame: 48 hours after enrollment
Patient-reported general quality of communication (QOC) received from study nephrologist
Time frame: 48 hours after enrollment
Patient-reported quality of end-of-life communication (QOC) received from study nephrologist
Time frame: 48 hours after enrollment
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
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
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
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
Initiation of dialysis as determined by chart review or report by patient or caregiver
Time frame: From enrollment for up to 2 years
Time to on-study death
Time frame: From enrollment for up to 2 years
Caregiver-reported quality of dying and death
Time frame: 3 months after death
Caregiver-reported health related quality of life
Time frame: Every 3 months for up to 2 years after enrollment
Caregiver-reported general quality of communication (QOC) received from study nephrologist
Time frame: Within 48 hours after enrollment
Caregiver-reported quality of end-of-life communication (QOC) received from study nephrologist
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
Time frame: Within 30 days before death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 22221483Schell 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.
- Background: PubMed 27576590Ladin 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.
- Derived from this study: PubMed 42698358Stalter LN, Hanlon BM, Bushaw KJ, Nitkowski J, Buffington A, Cheung KL, Zelenski AB, Kwekkeboom K, Bansal AD, Candice Crews D, Koncicki HM, Lam D, Moss AH, Rao MK, Felicity Wolfgram D, Yi J, Brill C, Isakova T, Schwarze ML. Best Case/Worst Case: A Multisite Randomized Trial of Scenario Planning for Patients With Late-Stage Kidney Disease. J Am Geriatr Soc. 2026 Sep 5. doi: 10.1111/jgs.70695. Online ahead of print.
- Derived from this study: PubMed 36328383Haug 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.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret L Schwarze, MD, MPP, FACS principal investigator
University of Wisconsin, Madison
Amar Bansal, MD principal investigator
University of Pittsburgh
Katharine Cheung, MD, PhD principal investigator
University of Vermont
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Case/Worst Case communication tool training in people with Palliative Care and Kidney Failure, Chronic, run by University of Wisconsin, Madison at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04466865, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.