Results Summary

What was the research about?

Chronic kidney disease, or CKD, occurs when the kidneys don’t work well to remove waste from the blood. Treatments include kidney transplant or dialysis, where a machine cleans the blood. Another option is supportive care, which focuses on managing symptoms without a transplant or dialysis.

In this study, the research team compared two ways to help patients and their care partners choose a treatment:

  • CKD education. Patients received printed and electronic copies of a CKD education pamphlet. They could also receive additional education on CKD in person or virtually. 
  • DART plus CKD education. Along with CKD education, patients received the Decision Aid for Renal Therapy, or DART. Decision aids help patients choose a treatment based on their preferences and goals for care. Within three months of their first visit, patients took 30–60 minutes to complete DART at home or in the clinic. DART had interactive videos about CKD, how to care for CKD, and making decisions about treatment. Patients entered their questions and care preferences into DART. Doctors received this information at patients’ next visits.

What were the results?

After three months, feelings of being conflicted about their treatment decision decreased more among patients who received DART than among patients who received CKD education alone.

The two groups didn’t differ in:

  • How much patients and care partners agreed on the goals of care
  • Patients’ skills and confidence to manage their CKD
  • How satisfied patients felt about their care

Patients and caregivers who received DART knew more about CKD than those who received CKD education alone. Patients who received DART were also more likely to be sure of their treatment preference than patients who received CKD education alone.

Who was in the study?

The study included 363 adults ages 70 and older with advanced CKD who were not on dialysis. All patients received care at one of four hospitals in the United States. Of these patients, 78 percent were White, 13 percent were Black or African American, 5 percent were Asian, and 4 percent were another race; 4 percent were Hispanic. The average age was 78, and 58 percent were men. The study also included 159 care partners. Of these, 62 percent were spouses and 20 percent were daughters of the patient.

What did the research team do?

The research team assigned patients by chance to receive either DART plus CKD education or CKD education alone.

At the start of the study and three months later, patients and their care partners completed surveys.

Patients with CKD, care partners of patients with CKD, health system representatives, doctors, and advocacy groups gave input throughout the study.

What were the limits of the study?

The study included patients who speak English. Results may differ for patients who don’t speak English.

Future research could test DART with more patients, including those who don’t speak English.

How can people use the results?

Clinics can use these results when considering ways to help older adults with CKD and their care partners make decisions about their care.

Final Research Report

This project's final research report is expected to be available by September 2024.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers asked for more information on the comparator condition, which was at times described as the control condition and other times as usual care. The researchers explained that the comparator condition was more than usual care since all participants in the study received an educational pamphlet from the National Kidney Foundation. They further revised the report to clarify that the care delivered in the comparative condition was dependent on the practices of the treating clinician in both study arms.
  • The reviewers noted that study participants may not have been representative of the population of older Medicare patients with severe chronic kidney disease (CKD). These concerns were raised because of the requirement for English fluency and the large number of patients who either declined to participate or whose clinicians did not recommend for the study. The researchers acknowledged these factors, but pointed out that their sample of patients closely matched the population of older adults with non-dialysis CKD stages 4-5 in several national databases, including Medicare.
  • The reviewers commented on the large number of study instruments completed by study participants and asked whether these instruments could have acted as an intervention on their own because of the focus on the importance of decision making. The researchers acknowledged this possibility but pointed out that if the study instruments did function as an intervention, that would have been true in both treatment conditions, which would bias the results so that the two conditions would be more similar. The researchers added this acknowledgement to their study limitations.

Conflict of Interest Disclosures

Project Information

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

Key Dates

November 2017
April 2023
2017
2023

Study Registration Information

^ © 2022 American College of Physicians. Used with permission. Access to this article is for personal reading only, and unauthorized reproduction or distribution of this article is prohibited.

Tags

Has Results
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: April 15, 2024