Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial

Completed · Not applicable

Conditions studied: Chronic Kidney Disease, End Stage Renal Disease

In brief

Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise and fatigue. The current accepted practice is often to administer erythropoietin-stimulating agents (ESAs), which act like the body's natural hormones to stimulate the production of red blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests that they are not as safe as previously thought. In this study, we seek to test a decision aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of the decision aid is to reduce patient confusion, improve their satisfaction with their care, improve their knowledge of kidney disease, and ultimately bring more clarity to patients about a controversial but ubiquitous drug. The decision aid will be about 1 page long and will include questions and information that might help the patient be more active and informed regarding the choice of a course of ESA therapy. We will ask patients to answer questions before and after their clinic visits regarding their satisfaction and confidence in their treatment and their knowledge of kidney disease; we will ask some of the same questions 3 months after the clinic visit. We will compare patients who are counseled using the decision aid to patients who are not. We anticipate total experiment running time to be approximately 5 months to recruit and follow up on all patients.

Key facts

Study ID

NCT01992926

Run by

Vanderbilt University

People needed

109

Starts

2013-11-01

Expected to finish

2014-08-01

Last updated by the study team

2015-01-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has Chronic Kidney Disease or End Stage Renal Disease
• Over 18, under 80 years of age
• Currently receiving care in the Vanderbilt Nephrology or Dialysis Clinics
• Receiving ESAs for anemia
• Speaks and can read English (no previous use of interpreter services)
• No significant visual impairment documented in medical record

You may not qualify if…

• Diagnosed cognitive disability
• Stated inability to converse and read fluently in English, or prior use of translation services
• Poor visual acuity

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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