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

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Behavioral: PREPARED Decision Support

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21239
      • Johns Hopkins University / Nephrology Center Of Maryland / Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Leigh E. Boulware, MD, MPH, Duke University

Publications and helpful links

General Publications

• DePasquale N, Ephraim PL, Ameling J, Lewis-Boyer L, Crews DC, Greer RC, Rabb H, Powe NR, Jaar BG, Gimenez L, Auguste P, Jenckes M, Boulware LE. Selecting renal replacement therapies: what do African American and non-African American patients and their families think others should know? A mixed methods study. BMC Nephrol. 2013 Jan 14;14:9. doi: 10.1186/1471-2369-14-9.
• Ameling JM, Auguste P, Ephraim PL, Lewis-Boyer L, DePasquale N, Greer RC, Crews DC, Powe NR, Rabb H, Boulware LE. Development of a decision aid to inform patients' and families' renal replacement therapy selection decisions. BMC Med Inform Decis Mak. 2012 Dec 1;12:140. doi: 10.1186/1472-6947-12-140.
• Sheu J, Ephraim PL, Powe NR, Rabb H, Senga M, Evans KE, Jaar BG, Crews DC, Greer RC, Boulware LE. African American and non-African American patients' and families' decision making about renal replacement therapies. Qual Health Res. 2012 Jul;22(7):997-1006. doi: 10.1177/1049732312443427.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: patient education; shared decision making; decision aids
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: Pro00051812; 1R34DK094116-01 (U.S. NIH Grant/Contract)