Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial
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|ClinicalTrials.gov Identifier: NCT01992926|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : January 22, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease End Stage Renal Disease||Behavioral: interactive educational intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Active Comparator: interactive educational intervention
Physicians will use an interactive educational worksheet during the standard-of-care clinic visit.
Behavioral: interactive educational intervention
Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.
No Intervention: control group
Physicians will conduct the standard-of-care clinic visit as usual.
- change in patient understanding of anemia and treatment options [ Time Frame: baseline and 3 months ]
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992926
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Kerri Cavanaugh, MD||Vanderbilt University|