Clinical trial NCT01992926: Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial
Official title: Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
End Stage Renal Disease
Keywords: health literacy
health numeracy
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: change in patient understanding of anemia and treatment options
timeFrame: baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Kerri Cavanaugh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beach LB, Wild M, Ramachandran G, Ikizler HO, Cavanaugh KL. Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease. BMC Nephrol. 2016 Jul 18;17(1):86. doi: 10.1186/s12882-016-0301-z.