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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: PREPARED Decision Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants randomized to this arm of the study will receive usual care from their physician. | |
| Experimental: PREPARED Decision Support<br>Participants randomized to this arm of the study will receive the PREPARED educational book and video. | Behavioral: PREPARED Decision Support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of self-care dialysis or receipt of transplant | 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. | 90 days after randomization | 
| Use of permanent vascular access | Proportion of patients achieving initiation of RRT with a permanent vascular access. | 90 days after randomization | 
| Emergent dialysis initiation | Proportion of patients initiating dialysis urgently in the Emergency Room (versus planned initiation). | 90 days after randomization | 
| Transplant evaluations, waiting list placement | Proportion of patients achieving receipt of transplant evaluations, or placement on the kidney transplant waiting list prior to initiation. | 90 days after randomization | 
| Blood pressure control at RRT initiation | 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. | 90 days after randomization | 
| Anemia management | 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. | 90 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient education, decision aids, shared decision making