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

NCT01992926 | Completed DMC

• 1 other identifier: 130784
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; End Stage Renal Disease

Keywords

health literacy; health numeracy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

interactive educational intervention

ACTIVE COMPARATOR

Physicians will use an interactive educational worksheet during the standard-of-care clinic visit.

Behavioral: interactive educational intervention

control group

NO INTERVENTION

Physicians will conduct the standard-of-care clinic visit as usual.

Interventions

interactive educational intervention BEHAVIORAL

Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.

interactive educational intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 27430294 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerri Cavanaugh, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 22, 2015

Record last verified: 2015-01

Locations

US (1)