Chronic Kidney Disease
Conditions
Keywords
shared decision making, patient education, decision aids
Brief summary
This study evaluates the effectiveness of patient educational materials (a book and DVD) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the educational materials and half will receive usual care from their doctors.
Detailed description
The investigators will study the effectiveness of patient educational materials (a book and DVD, called the PREPARED materials) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the PREPARED materials and half will receive usual care from their doctors. PREPARED materials feature patients and their families discussing the pros and cons of different treatment options for kidney failure. The investigators will randomly assign patients already under the care of a nephrologist to receive the video and book or to receive their usual nephrology care. They will measure the degree to which patients in either study arm are prepared for kidney failure treatment at follow up.
Interventions
BEHAVIORALPREPARED Decision Support
The PREPARED DVD presents patient and health care provider testimonials that characterize the pros and cons of different kidney replacement treatment options, including in-center hemodialysis, home hemodialysis, peritoneal dialysis, kidney transplant, and conservative management (i.e., no dialysis or transplant). The PREPARED book reinforces differences between the treatments by showing (in lay language) summaries of scientific evidence on treatment outcomes associated with each kidney replacement option.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * English speaking * Advanced kidney disease defined as an eGFR \< 20 mL/min/1.73m2 at their last clinical appointment with their nephrologist * Have not initiated a Renal Replacement Therapy
Exclusion criteria
* Cannot speak English * Have initiated Renal Replacement Therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure control at RRT initiation | 90 days after randomization | Proportion of patients achieving blood pressure control (systolic blood pressure \<130mmHg and diastolic blood pressure \<80mmHg) at each visit prior to RRT initiation or completion of study follow up. |
| Anemia management | 90 days after randomization | Proportion of patients with anemia treated to recommended levels (hemoglobin 10g/dl to 12g/dl) at each visit prior to RRT initiation or completion of study follow up. |
| Initiation of self-care dialysis or receipt of transplant | 90 days after randomization | Among the participants initiating renal replacement therapy (RRT) during follow up, the proportion who initiate self-care dialysis (peritoneal dialysis or home hemodialysis) or receive a transplant. |
| Use of permanent vascular access | 90 days after randomization | Proportion of patients achieving initiation of RRT with a permanent vascular access. |
| Emergent dialysis initiation | 90 days after randomization | Proportion of patients initiating dialysis urgently in the Emergency Room (versus planned initiation). |
| Transplant evaluations, waiting list placement | 90 days after randomization | Proportion of patients achieving receipt of transplant evaluations, or placement on the kidney transplant waiting list prior to initiation. |
Countries
United States
Outcome results
None listed