Communication Tool Training for Kidney Failure

Not currently recruiting at 11 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Currently on dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for discussing treatment choices with older adults who have end-stage kidney disease. It focuses on a communication tool called "Best Case/Worst Case" to facilitate discussions between patients and doctors about options like palliative care and treatment intensity at the end of life. The trial aims to determine if this tool enhances quality of life and communication. It suits individuals with severe kidney problems who are not currently on dialysis and may have other serious health issues. Participants' nephrologists will either receive training to use this tool or continue with usual care conversations. As an unphased trial, this study provides a unique opportunity to improve communication strategies for end-of-life care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on communication training rather than medication changes.

What prior data suggests that the Best Case/Worst Case communication tool is safe for use with patients with end-stage renal disease?

Research has shown that the "Best Case/Worst Case" (BC/WC) tool helps doctors and patients communicate clearly about treatment options. It has been tested with patients in other areas, such as surgery, without any safety issues, confirming its safe use.

The tool focuses on training doctors to communicate better, posing no direct risks to patients. It aims to enhance understanding between doctors and patients when discussing treatment choices. Studies have not reported any harmful effects from using the BC/WC tool. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Best Case/Worst Case communication tool for kidney failure because it introduces a new way of discussing treatment options. Unlike traditional conversations that often focus solely on dialysis logistics, this tool encourages nephrologists to discuss a broader range of possibilities, including conservative management or the option of "no dialysis." By providing a structured way to talk about the best and worst outcomes, it aims to empower patients to make more informed decisions about their care.

What evidence suggests that the Best Case/Worst Case communication tool is effective for improving care for patients with end-stage renal disease?

Research shows that the Best Case/Worst Case (BC/WC) tool, tested in this trial, helps doctors discuss treatment options with patients. This tool uses different scenarios to aid decision-making. Studies have found that it enhances collaborative decision-making between patients and doctors, especially for those considering dialysis. Early results suggest that this tool improves communication and decision-making. It helps patients understand their options, leading to more personalized and effective care. Participants in this trial will either receive usual care or have their nephrologists use the BC/WC tool during consultations. ^{1 3 6 7 8}

Who Is on the Research Team?

Jean Kutner, MD

Principal Investigator

University of Colorado, Denver

Alvin Moss, MD

Principal Investigator

West Virginia University

Margaret L Schwarze, MD, MPP, FACS

Principal Investigator

University of Wisconsin, Madison

Amar Bansal, MD

Principal Investigator

University of Pittsburgh

Katharine Cheung, MD, PhD

Principal Investigator

University of Vermont

Deidra Crews, MD

Principal Investigator

Johns Hopkins University

Katie Colborn, PhD

Principal Investigator

University of Colorado, Denver

Daniel Lam, MD

Principal Investigator

University of Washington

Maya Rao, MD

Principal Investigator

Columbia University

Dawn Wolfgram, MD

Principal Investigator

Medical College of Wisconsin

Jeniann Yi, MD

Principal Investigator

University of Colorado, Denver

Tamara Isakova, MD

Principal Investigator

Northwestern University

Holly Koncicki, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for older adults with severe kidney disease (eGFR ≤ 24) who are not on dialysis but may have had it before or have the access in place. They must be over 80, have other serious illnesses, or their doctor wouldn't be surprised if they passed away within a year. Participants should speak English and be able to make decisions.

Inclusion Criteria

Your kidney function, as measured by eGFR, is very low.

I am over 80, have a serious health condition, or my doctor wouldn't be surprised if I passed away within a year.

I am not currently undergoing dialysis.

Exclusion Criteria

I am currently receiving dialysis.

I am unable to make my own medical decisions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Nephrologists receive training on the Best Case/Worst Case communication tool, and participants receive care based on whether their nephrologist has been trained or not.

Duration not specified

Follow-up

Participants are monitored for quality of life, quality of communication, and receipt of palliative care through surveys and chart reviews.

Up to 2 years

End-of-life assessment

Assessment of treatment intensity and quality of dying and death through chart reviews and caregiver reports.

Within 30 days of death

What Are the Treatments Tested in This Trial?

Interventions

• Best Case/Worst Case communication tool training

Trial Overview The study tests a 'Best Case/Worst Case' communication tool training for doctors at nephrology clinics. It aims to see if this improves end-of-life care quality and decision-making for patients with end-stage renal disease by comparing trained doctors to those waiting for training.

How Is the Trial Designed?

Group I: Best Case/Worst Case communication tool Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

The Palliative Care Research Cooperative Group

Collaborator

Trials

1

Recruited

410+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

University of Vermont

Collaborator

Trials

283

Recruited

3,747,000+

Published Research Related to This Trial

A study of 377 Texas pharmacists revealed that 67.9% had never reported adverse drug events (ADEs) to the FDA, indicating a significant gap in reporting practices.

Most pharmacists (65.7%) felt they lacked adequate knowledge about ADE reporting, highlighting the need for improved education and training on how to report ADEs effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Texas pharmacists' knowledge of reporting serious adverse drug events to the Food and Drug Administration. Gavaza, P., Brown, CM., Lawson, KA., et al.[2015]

About 63% of long-term care facilities in the Czech Republic have some form of adverse event reporting process, but many of these systems are underdeveloped and rely mainly on paper records.

Interviews revealed that while staff recognize the importance of reporting adverse events, there is a significant gap in knowledge and skills needed to create effective reporting systems, indicating a need for better training and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in Czech long-term care facilities. Hěib, Z., Vychytil, P., Marx, D.[2016]

A survey of 228 pharmacy students revealed that most believe the FDA is more proactive than pharmaceutical companies in addressing adverse events, indicating a gap in understanding the roles of these entities.

Many students had misconceptions about how adverse event reports are processed and the impact of HIPAA regulations, highlighting the need for improved education on adverse event reporting before they enter practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacy student perceptions of adverse event reporting. Kalari, S., Dormarunno, M., Zvenigorodsky, O., et al.[2023]

The study identified three types of adverse events in communication skills training (CST) for physicians, including emotional trauma from personal experiences, lack of empathetic feedback, and referrals for remedial training as a risk management strategy.

To enhance the safety and effectiveness of CST, it is crucial for facilitators to recognize emotional cues and risk factors early, and to master specific feedback techniques that can prevent potential adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Averting adverse events in communication skills training: a case series. Levin, T., Horner, J., Bylund, C., et al.[2010]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9639110/

Best Case/Worst Case: protocol for a multisite randomised ... This article describes the protocol for a multisite, cluster randomised trial to test the effect of training nephrologists to use the BC/WC communication tool.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36328383/

protocol for a multisite randomised clinical trial of a scenario ... Best Case/Worst Case (BC/WC) is a communication tool that uses scenario planning to support patients' decision making.

3. liebertpub.com liebertpub.com/doi/full/10.1089/jpm.2019.0340

Opportunities to Improve Shared Decision Making in ... Objective: To train nephrologists to use the best case/worst case (BC/WC) communication tool to improve shared decision making about dialysis ...

4. withpower.com withpower.com/trial/phase-renal-insufficiency-10-2020-75060

Communication Tool Training for Kidney Failure 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 ...

5. database.clin-star.org database.clin-star.org/display/project-5R01AG06536505

A Multisite Randomized Clinical Trial of Scenario Planning ... We aim to test the effect of the Best Case/Worst Case intervention on receipt of palliative care and intensity of treatment at the end of life (Aim 1), quality ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/65/NCT04466865/SAP_001.pdf

NCT04466865 SAP Version Date: 3/29/22 Best Case/Worst We expect that use of the Best Case/Worst Case communication tool will help nephrologists and patients identify the need for palliative care ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772628224000086

Ensuring competency and fidelity This analysis describes the outcomes of training nephrology clinicians to use the Best Case/Worst Case Communication intervention during an RCT to ensure ...

8. patientpreferences.org patientpreferences.org/bcwc-nephrology/

Best Case/Worst Case: Nephrology Best Case/Worst Case uses narrative and a hand-written graphic aid to illustrate a choice between treatments and engage patients in deliberation.