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

Primary Purpose

Chronic Kidney Disease, End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
interactive educational intervention
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease focused on measuring health literacy, health numeracy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

interactive educational intervention

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
November 14, 2013
Last Updated
January 21, 2015
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01992926
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End Stage Renal Disease
Keywords
health literacy, health numeracy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interactive educational intervention
Arm Type
Active Comparator
Arm Description
Physicians will use an interactive educational worksheet during the standard-of-care clinic visit.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Physicians will conduct the standard-of-care clinic visit as usual.
Intervention Type
Behavioral
Intervention Name(s)
interactive educational intervention
Intervention Description
Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.
Primary Outcome Measure Information:
Title
change in patient understanding of anemia and treatment options
Description
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)
Time Frame
baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Cavanaugh, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27430294
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.
Results Reference
derived

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

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