A Communication Tool to Assist Older Adults Facing Dialysis Choices

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Best Case/Worst Case communication tool training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Best Case/Worst Case communication tool<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>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?
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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 |