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A Communication Tool to Assist Older Adults Facing Dialysis Choices

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ClinicalTrials.gov Identifier: NCT04466865
Recruitment Status : Enrolling by invitation
First Posted : July 10, 2020
Last Update Posted : December 28, 2020
Sponsor:
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
The Palliative Care Research Cooperative Group
Information provided by (Responsible Party):
University of Wisconsin, Madison

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 eight 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.


Condition or disease Intervention/treatment Phase
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 Other: Best Case/Worst Case communication tool training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Best Case/Worst Case: A Multisite Randomized Clinical Trial of Scenario Planning for Patients With End-Stage Kidney Disease
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Best Case/Worst Case communication tool
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

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.


No Intervention: Usual Care
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.



Primary Outcome Measures :
  1. 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 ]
    Number of patients with 1 or more palliative care consults within 12 months of study enrollment.

  2. 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 ]
    Number of patients with 1 or more ICU admission within 30 days of death.


Secondary Outcome Measures :
  1. 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 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 change (slope) in health-related quality of life over time. Possible scores range from 0-184. Higher scores indicate better quality of life.

  2. Patient-reported general quality of communication (QOC) received from study nephrologist [ Time Frame: 48 hours after enrollment ]
    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.

  3. Patient-reported quality of end-of-life communication (QOC) received from study nephrologist [ Time Frame: 48 hours after enrollment ]
    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.

  4. 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 ]
    Number of patients with receipt of any palliative care as determined by chart review or patient or caregiver report during 2-year follow up.

  5. 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 ]
    Number of patients with documentation of hospice enrollment as determined by chart review and patient or caregiver report during 2-year follow up.

  6. 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 ]
    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.

  7. 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 ]
    Number 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.

  8. 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 ]
    Number of patients who had one or more surgical procedure within 30 day as determined by chart review or patient or caregiver report.

  9. Initiation of dialysis as determined by chart review or report by patient or caregiver [ Time Frame: From enrollment for up to 2 years ]
    Number of patients initiating dialysis as determined by chart review or patient or caregiver report.

  10. Withdrawal of dialysis as determined by chart review or report by patient or caregiver [ Time Frame: From enrollment for up to 2 years ]
    Number of patients withdrawing from dialysis treatment as determined by chart review or patient or caregiver report.

  11. Time to on-study death [ Time Frame: From enrollment for up to 2 years ]
    Time, in months, from study start to on-study death. 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.

  12. Caregiver-reported quality of dying and death [ Time Frame: 3 months after 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.

  13. Caregiver-reported health related quality of life [ Time Frame: Every 3 months for up to 2 years after enrollment ]
    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.

  14. Caregiver-reported general quality of communication (QOC) received from study nephrologist [ Time Frame: Within 48 hours after enrollment ]
    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.

  15. Caregiver-reported quality of end-of-life communication (QOC) received from study nephrologist [ Time Frame: Within 48 hours after enrollment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) of less than 20
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466865


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, New York
Columbia University
New York, New York, United States, 10027
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Pennsylvania
University of Pittsburg
Pittsburgh, Pennsylvania, United States, 15260
United States, Vermont
Department of Medicine, University of Vermont
Burlington, Vermont, United States, 05405
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Wisconsin, Madison
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
The Palliative Care Research Cooperative Group
Investigators
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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
Publications:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04466865    
Other Study ID Numbers: 2019-1074
1R01AG065365-01 ( U.S. NIH Grant/Contract )
A539750 ( Other Identifier: UW, Madison )
SMPH/SURGERY ( Other Identifier: UW, Madison )
Protocol Version 12/16/2019 ( Other Identifier: UW Madison )
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A de-identified data set from this project will be stored in the Palliative Care Research Cooperative Group (PCRC) De-identified Data Repository (DiDR).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: One year after study completion or two months after initial manuscript has been accepted for publication (whichever comes first), UW will securely transfer a de-identified dataset to the PCRC Data Repository.
Access Criteria: Investigators may request access to de-identified study data for secondary analyses using the PCRC Data Repository webform. Requests must include a summary of the following: research questions, objectives, hypotheses, statistical analysis plan, and project timeline. Requestors must provide a list of specific variables they would like included in the secondary data set. Each request must also include a data security plan and explanation of how the data will be stored and who will have access to it. The PCRC staff and UW PI will review all requests assessing the scientific integrity, feasibility and analytic rigor.
URL: https://palliativecareresearch.org/corescenters/data-informatics-statistics-core-disc/pcrc-de-identified-data-repository-didr

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic