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Clinical Trials/NCT02428569
NCT02428569
Completed
N/A

Providing Resources to Enhance Patients' Readiness to Make Decisions About Kidney Disease: Partnering to Break the News, Review All Options, Weigh Pros and Cons (PREPARE NOW)

Duke University1 site in 1 country24 target enrollmentMay 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
Duke University
Enrollment
24
Locations
1
Primary Endpoint
Initiation of self-care dialysis or receipt of transplant
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
April 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Initiation of self-care dialysis or receipt of transplant

Time Frame: 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

Time Frame: 90 days after randomization

Proportion of patients achieving initiation of RRT with a permanent vascular access.

Emergent dialysis initiation

Time Frame: 90 days after randomization

Proportion of patients initiating dialysis urgently in the Emergency Room (versus planned initiation).

Transplant evaluations, waiting list placement

Time Frame: 90 days after randomization

Proportion of patients achieving receipt of transplant evaluations, or placement on the kidney transplant waiting list prior to initiation.

Blood pressure control at RRT initiation

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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