title: Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov, number NCT01992926 . Registered 11/14/2013.
authors.affiliation: Division of Nephrology & Hypertension, Vanderbilt University Medical Center, 1161 21st Avenue South, S-3223 MCN, Nashville, TN, 37232, USA.|Vanderbilt Center for Kidney Disease, Nashville, TN, USA.
authors.forename: Lauren B
authors.initials: LB
authors.lastname: Beach
authors.affiliation: Division of Nephrology & Hypertension, Vanderbilt University Medical Center, 1161 21st Avenue South, S-3223 MCN, Nashville, TN, 37232, USA.|Vanderbilt Center for Kidney Disease, Nashville, TN, USA.
authors.forename: Marcus
authors.initials: M
authors.lastname: Wild
authors.affiliation: University of Toledo College of Medicine, Toledo, OH, USA.
authors.forename: Gowri
authors.initials: G
authors.lastname: Ramachandran
authors.affiliation: University of Vermont College of Medicine, Burlington, VT, USA.
authors.forename: H Omer
authors.initials: HO
authors.lastname: Ikizler
authors.affiliation: Division of Nephrology & Hypertension, Vanderbilt University Medical Center, 1161 21st Avenue South, S-3223 MCN, Nashville, TN, 37232, USA. kerri.cavanaugh@vanderbilt.edu.|Vanderbilt Center for Kidney Disease, Nashville, TN, USA. kerri.cavanaugh@vanderbilt.edu.
authors.forename: Kerri L
authors.identifier: 0000-0002-4031-1714
authors.initials: KL
authors.lastname: Cavanaugh
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D000066491:Clinical Decision-Making / Q000379:methods*; D004921:Erythropoietin / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D006397:Hematinics / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin
keywords: Anemia; Chronic kidney disease; Decision aid; Dialysis; End stage renal disease; Erythropoietin stimulating agent; IPDAS; Patient provider communication; Shared decision making