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

NCT02428569 | Completed DMC

• 2 other identifiers: Pro000518121R34DK094116-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

shared decision making; patient education; decision aids

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Usual Care

NO INTERVENTION

Participants randomized to this arm of the study will receive usual care from their physician.

PREPARED Decision Support

EXPERIMENTAL

Participants randomized to this arm of the study will receive the PREPARED educational book and video.

Behavioral: PREPARED Decision Support

Interventions

PREPARED Decision Support BEHAVIORAL

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.

PREPARED Decision Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cannot speak English
• Have initiated Renal Replacement Therapy

Sponsors & Collaborators

• Duke University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

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

Baltimore, Maryland, 21239, United States

Location

Related Publications (3)

• 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.

  PMID: 23317336 BACKGROUND

• 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.

  PMID: 23198793 BACKGROUND

• 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.

  PMID: 22645225 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Leigh E. Boulware, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: April 29, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

US (1)