Providing Resources to Enhance Patients' Readiness to Make Decisions About Kidney Disease: The PREPARE NOW Study

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Behavioral: PREPARED Decision Support

• Registration Number: NCT02428569
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-29
• Study Start: 2015-05
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PREPARED Decision Support	PREPARED Decision Support	Participants randomized to this arm of the study will receive the PREPARED educational book and video.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Johns Hopkins University / Nephrology Center Of Maryland / Good Samaritan Hospital; 🇺🇸 Baltimore, Maryland, United States