Clinical trial NCT04466865: A Communication Tool to Assist Older Adults Facing Dialysis Choices
Official title: Best Case/Worst Case: A Multisite Randomized Clinical Trial of Scenario Planning for Patients With End-Stage Kidney Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of Pittsburgh
name: University of Vermont
name: Johns Hopkins University
name: University of Colorado, Denver
name: Icahn School of Medicine at Mount Sinai
name: University of Washington
name: West Virginia University
name: Columbia University
name: Medical College of Wisconsin
name: The Palliative Care Research Cooperative Group
name: Northwestern University
First posted: 2020-07-10
Enrollment: 407
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Receipt of palliative care consult within 12 months of study enrollment, as determined by chart review or report by patient or caregiver
timeFrame: from enrollment up to 12 months, data collected up to 2 years
Secondary outcomes:
measure: Receipt of palliative care during 2-year follow up as determined by chart review or report by patient or caregiver
timeFrame: From enrollment for up to 2 years
measure: Patient-reported health-related quality of life
timeFrame: Every 3 months for up to 2 years after enrollment
measure: Patient-reported health-related quality of life
timeFrame: Every 3 months for up to 2 years after enrollment
measure: Patient-reported health-related quality of life
timeFrame: Every 3 months for up to 2 years after enrollment
measure: Patient-reported quality of communication (QOC) received from study nephrologist
timeFrame: 48 hours after enrollment
measure: Patient-reported general quality of communication (QOC) received from study nephrologist
timeFrame: 48 hours after enrollment
measure: Patient-reported quality of end-of-life communication (QOC) received from study nephrologist
timeFrame: 48 hours after enrollment
measure: Hospice enrollment during 2-year follow up as determined by chart review or report by patient or caregiver
timeFrame: From enrollment for up to 2 years
measure: Documentation of new advance care planning during 2-year follow up as determined by chart review or report by patient or caregiver
timeFrame: From enrollment for up to 2 years
measure: Treatment intensity at the end of life review as determined by chart review or report by patient or caregiver
timeFrame: Within 30 days of death
measure: Surgical treatment intensity at the end of life as determined by chart review or report by patient or caregiver
timeFrame: Within 30 days of death
measure: Initiation of dialysis as determined by chart review or report by patient or caregiver
timeFrame: From enrollment for up to 2 years
measure: Time to on-study death
timeFrame: From enrollment for up to 2 years
measure: Caregiver-reported quality of dying and death
timeFrame: 3 months after death
measure: Caregiver-reported health related quality of life
timeFrame: Every 3 months for up to 2 years after enrollment
measure: Caregiver-reported general quality of communication (QOC) received from study nephrologist
timeFrame: Within 48 hours after enrollment
measure: Caregiver-reported quality of end-of-life communication (QOC) received from study nephrologist
timeFrame: Within 48 hours after enrollment
measure: Treatment intensity at the end of life as determined by chart review or report by patient or caregiver
timeFrame: Within 30 days before death
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Burlington
country: United States
facility: Department of Medicine, University of Vermont
state: Vermont
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Margaret L Schwarze, MD, MPP, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Amar Bansal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Katharine Cheung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Deidra Crews, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Katie Colborn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Holly Koncicki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Jean Kutner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Daniel Lam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University
name: Alvin Moss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Maya Rao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Dawn Wolfgram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Jeniann Yi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Tamara Isakova, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Haug 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.