Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
  • Dialysis
  • Communication
  • Decision Aid
  • Decision Making
  • Decision Support Techniques
  • Palliative Care
  • End of Life
  • Renal Dialysis
  • End Stage Renal Disease
  • Nephrologists
  • Kidney Diseases
  • Kidney Failure Chronic
  • Late-Stage Renal Disease
  • Life-Supporting Treatments
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Other

Participation Requirements

Age
Between 60 years and 125 years
Gender
Both males and females

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 en...

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.

Tracking Information

NCT #
NCT04466865
Collaborators
  • Columbia University
  • 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
  • Medical College of Wisconsin
  • The Palliative Care Research Cooperative Group
Investigators
Principal Investigator: Margaret L Schwarze, MD, MPP, FACS University of Wisconsin, Madison Principal Investigator: Amar Bansal, MD University of Pittsburgh Principal Investigator: Katharine Cheung, MD, PhD University of Vermont Principal Investigator: Deidra Crews, MD Johns Hopkins University Principal Investigator: Katie Colborn, PhD University of Colorado, Denver Principal Investigator: Holly Koncicki, MD Icahn School of Medicine at Mount Sinai Principal Investigator: Jean Kutner, MD University of Colorado, Denver Principal Investigator: Daniel Lam, MD University of Washington Principal Investigator: Alvin Moss, MD West Virginia University Principal Investigator: Maya Rao, MD Columbia University Principal Investigator: Dawn Wolfgram, MD Medical College of Wisconsin