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. In the meantime, results have been published in peer-reviewed journals, as listed below.
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 |
|
| 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 |
Journal Citations
Results of This Project
Related Journal Citations
Project Information
Key Dates
Study Registration Information
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