Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Chronic kidney disease, or CKD, is a health problem in which the kidneys do not remove waste from the blood well. Some people with CKD have kidney failure, which means that they lose most of their kidney function. Treatment options for CKD include kidney transplant or dialysis, a treatment where a machine cleans the blood. Another option is supportive care, which focuses on managing symptoms and maintaining quality of life without transplant or dialysis. But patients with CKD may not know about their options for treatment or the benefits and harms of each choice. Learning about CKD treatment options can help patients and their care partners choose the treatment that best matches their goals for care.

In this study, the research team is comparing two ways to help patients with CKD and their care partners learn about and decide on a treatment. The first way is education from a doctor as usual plus a booklet on CKD treatment. The second way is education from a doctor, the booklet, and a web-based, interactive decision aid called Decision Aid for Renal Therapy, or DART. Decision aids help people choose between two or more healthcare options based on what is most important to them.

Who can this research help?

Clinicians such as doctors and nurses can use results from this study when considering how to help patients with CKD and their care partners make informed choices about their treatment options.

What is the research team doing?

The research team is working with clinical research centers in four states to enroll 400 patients 70 years and older with CKD. Patients invite a care partner to take part in the study with them. The team assigns patient-caregiver pairs to one of two groups by chance. Patients and care partners in the first group receive education on CKD treatment at their doctor visit, as usual. This group also receives a booklet called Choosing a Treatment for Kidney Failure published by the National Kidney Foundation.

Patients and care partners in the second group receive education on CKD treatment from their doctor as usual, the booklet, and DART. DART presents information about CKD treatment in plain language that is easy to understand. DART prompts patients and care partners to think about their preferences for care. Patients and care partners view DART within three months of their doctor visit at home or in the clinic. They can also use DART to record questions they would like to ask at their next doctor visit.

The research team is surveying patients and care partners at the start of the study and at 3- to 6-month intervals for up to 18 months. The team is asking patients and care partners how confident they feel about making CKD treatment decisions and how satisfied they are with care. Also, the team is looking to see how closely care partner and patient goals align. Finally, the team is recording whether patients complete an advance directive. Advance directives are written statements that describe a patient’s wishes for care if they become so ill that they aren’t able to communicate. The team is comparing these outcomes between the group that receives education as usual plus the booklet, with the group that receives education, the booklet, and DART.

The research team is also conducting interviews with patients, care partners, and clinicians to understand

  • How patients and caregivers make decisions together
  • How patients and caregivers use DART
  • DART’s effect on decision-making experiences and study results
  • Clinicians’ perspectives

Patients with CKD, care partners, clinicians, kidney societies, dialysis companies, and social workers help with this study. They help design, plan, and recruit for the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 400 adults ages 70 and older with stage 4 or 5 CKD who do not have an established dialysis start or transplant date within 3 months of study start
Interventions/
Comparators
  • In-person education (usual care) plus the Choosing a Treatment for Kidney Failure educational booklet published by the National Kidney Foundation
  • In-person education (usual care), the Choosing a Treatment for Kidney Failure educational booklet, plus the Decision Aid for Renal Therapy (DART)
Outcomes

Primary: decisional conflict (at 3 months)

Secondary: decisional conflict (at 18 months), advance directive completion, patient satisfaction with care, caregiver satisfaction with care, dialysis initiation, patient-caregiver concordance

Timeframe 3-month follow-up for primary outcome

Project Information

Keren Ladin, PhD, MS
Daniel E Weiner, MD, MS
Tufts University
$2,169,297
Promoting Autonomy and Improving Shared Decision Making for Older Adults with Advanced Kidney Disease

Key Dates

November 2017
April 2023
2017

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022