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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Kidney Disease, End Stage Renal Disease

Intervention / Treatment
-----------------
* Behavioral: interactive educational intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: interactive educational intervention<br>Physicians will use an interactive educational worksheet during the standard-of-care clinic visit. | Behavioral: interactive educational intervention<br>* Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.<br>|
| No Intervention: control group<br>Physicians will conduct the standard-of-care clinic visit as usual. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in patient understanding of anemia and treatment options | Change from baseline in the following surveys/questionaires at 3 months: Anemia Knowledge Survey (PAKKD) Perceived Kidney Self-Management Scale (PKiSMS or PDiSMS for ESRD) Social Support Measure (MSPSS) Perceived Efficacy in Patient-Physician Interactions (PEPPI) | baseline and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
health literacy, health numeracy