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

• ClinicalTrials.gov Identifier: NCT02428569
• Recruitment Status: Completed
• First Posted: April 29, 2015
• Last Update Posted: February 27, 2019
• Sponsor: Duke University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Disease	Behavioral: PREPARED Decision Support	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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)
• Study Start Date: May 2015
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: April 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Use of permanent vascular access [ Time Frame: 90 days after randomization ]
   Proportion of patients achieving initiation of RRT with a permanent vascular access.
3. Emergent dialysis initiation [ Time Frame: 90 days after randomization ]
   Proportion of patients initiating dialysis urgently in the Emergency Room (versus planned initiation).
4. 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.
5. 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.
6. 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University / Nephrology Center Of Maryland / Good Samaritan Hospital

Baltimore, Maryland, United States, 21239

Sponsors and Collaborators

Duke University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Leigh E. Boulware, MD, MPH; Duke University

More Information

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02428569
• Other Study ID Numbers: Pro00051812; 1R34DK094116-01 ( U.S. NIH Grant/Contract )
• First Posted: April 29, 2015
• Last Update Posted: February 27, 2019
• Last Verified: February 2019

Keywords provided by Duke University:

shared decision making; patient education; decision aids

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes