A Communication Tool to Assist Older Adults Facing Dialysis Choices

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04466865
• Other study ID #: 2022-0193
• Secondary ID: 1R01AG065365-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 407
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Department of Medicine, University of Vermont	Burlington	Vermont
United States	Northwestern University	Chicago	Illinois
United States	University of Colorado, Denver	Denver	Colorado
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	West Virginia University	Morgantown	West Virginia
United States	Columbia University	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (13)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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