Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease

Abstract

Background: Erythropoiesis-stimulating agents (ESAs) are commonly used for the treatment of anemia due to chronic kidney disease (CKD) and end stage renal disease (ESRD). Patients often lack an understanding of the potential risks and benefits of ESAs, despite government mandated education on this topic. Decision aids are tools commonly used to discuss important information in health care settings. To address this knowledge gap, we designed this study to evaluate the effectiveness of a novel ESA decision aid at promoting informed shared decision making (ISDM) between patients and providers related to ESA use for CKD- and ESRD-related anemia.

Methods: Using the principles of informed shared decision making theory, we designed and piloted an ESA decision aid intended to increase CKD and ESRD patient understanding of the potential risks and benefits of ESAs. Informed by the findings during development, the ESA decision aid was modified and finalized for testing. We will perform a randomized clinical trial to assess if administration of the ESA decision aid improves patient understanding of the risks and benefits of ESA use compared to control patients receiving standard care. Participants with either CKD or ESRD and who are receiving ESAs will be eligible for participation. The primary outcome is patients' score on the Patient Anemia Knowledge in Kidney Disease (PAKKD) survey assessed at enrollment and 3 months after. Secondary outcomes include decisional conflict related to ESAs, and patient satisfaction with provider communication.

Discussion: The Anemia Risk Communication for patients with Kidney Disease (ARC-KD) study will assess the effectiveness of a novel ESA decision aid to improve patient understanding of ESA use to manage CKD- and ESRD-related anemia. This decision aid is the first resource targeted to improve patient understanding of anemia management in the kidney health context. With the increasing options available for anemia management, this will serve as an important foundation to evolve in the future to optimize anemia-related shared decision making.

Trial registration: ClinicalTrials.gov, number NCT01992926 . Registered 11/14/2013.

Keywords: Anemia; Chronic kidney disease; Decision aid; Dialysis; End stage renal disease; Erythropoietin stimulating agent; IPDAS; Patient provider communication; Shared decision making.

Fig. 1

ARC-KD Study Planning Diagram. Phase 1 (left side). Development of the ESA decision aid. Phase 2 (right side) randomized clinical trial to evaluate effect of ESA decision aid

Fig. 2

Draft ESA Decision Aid. The draft ESA decision aid contains 6 sections organized to be delivered to patients from right to left, then top to bottom. The “Men” and “Women” bars in Sections 1 and 2 represent the hemoglobin levels of individuals without kidney disease, while the “too high” and “too low” bars represent the high and low ranges of hemoglobin levels for individuals with kidney disease, respectively. Section 3 includes information to educate patients about the impact of anemia on patient health and wellness. Section 4 presents the potential health risks of using ESAs to manage anemia, while Section 5 presents the potential benefits. Section 6 contains checkboxes to assist patients with planning their future ESA use

Fig. 3

Revised ESA Decision Aid. The revised ESA decision aid contains 6 sections organized to be delivered to patients from top to bottom. Section 1 explains the mechanism for how and why ESAs are used to treat anemia in kidney disease patients. Section 2 raises patient awareness of their current hemoglobin level and encourages them to set a new goal hemoglobin level with their providers. Section 3 presents the benefits of ESAs, while Section 4 presents the risks. Section 5 contains additional information to help patients understand the impact of their decision to use ESAs on downstream treatment options related to broader kidney health outcomes. Section 6 includes checkboxes to assist patients with planning their future ESA use