Communication Tool Training for Kidney Failure

Recruiting at 10 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

407 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Best Case/Worst Case communication tool training for kidney failure?

Research shows that using communication tools, like those in the NephroTalk framework, can help doctors have better conversations with patients about serious health issues, which can improve decision-making and patient satisfaction. This suggests that similar tools, like the Best Case/Worst Case communication tool, could be effective in enhancing communication for kidney failure treatment. ^{1 2 3 4 5}

Is the Best Case/Worst Case communication tool training safe for humans?

There is no specific safety data available for the Best Case/Worst Case communication tool training in humans, but communication skills training in general has been studied for potential adverse events, suggesting that risks are considered and strategies to reduce them are explored. ^{6 7 8 9 10}

How does the Best Case/Worst Case communication tool training differ from other treatments for kidney failure?

The Best Case/Worst Case communication tool training is unique because it focuses on improving shared decision-making between nephrologists and patients with kidney failure, particularly for older adults with limited life expectancy. Unlike traditional treatments that focus on medical interventions, this approach enhances communication skills to help patients understand their options, including the choice between starting dialysis or opting for palliative care. ^{2 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

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

Jean Kutner, MD

Principal Investigator

University of Colorado, Denver

Daniel Lam, MD

Principal Investigator

University of Washington

Alvin Moss, MD

Principal Investigator

West Virginia University

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pilot study of a physician-delivered education tool to increase patient knowledge about CKD. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

NephroTalk: communication tools to enhance patient-centered care. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

A Nephrology Fellows' Communication Skills Course: An Educational Quality Improvement Report. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

How the Routine Use of Patient-Reported Outcome Measures for Hemodialysis Care Influences Patient-Clinician Communication: A Mixed-Methods Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The outcomes of ESRD and its treatment. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Averting adverse events in communication skills training: a case series. [2010]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse drug reactions: when the risk becomes a reality for patients. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Texas pharmacists' knowledge of reporting serious adverse drug events to the Food and Drug Administration. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacy student perceptions of adverse event reporting. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting in Czech long-term care facilities. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Opportunities to Improve Shared Decision Making in Dialysis Decisions for Older Adults with Life-Limiting Kidney Disease: A Pilot Study. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Communication skills training for dialysis decision-making and end-of-life care in nephrology. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Improving Communication Skills within the Nephrology Unit. [2019]

14. France pubmed.ncbi.nlm.nih.gov

[Physician-patient communication in nephrology]. [2011]