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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PREPARED Decision Support
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring shared decision making, patient education, decision aids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

PREPARED Decision Support

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Use of permanent vascular access
Proportion of patients achieving initiation of RRT with a permanent vascular access.
Emergent dialysis initiation
Proportion of patients initiating dialysis urgently in the Emergency Room (versus planned initiation).
Transplant evaluations, waiting list placement
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2015
Last Updated
February 26, 2019
Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02428569
Brief Title
Providing Resources to Enhance Patients' Readiness to Make Decisions About Kidney Disease: The PREPARE NOW Study
Acronym
PREPARE NOW
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 Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
shared decision making, patient education, decision aids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants randomized to this arm of the study will receive usual care from their physician.
Arm Title
PREPARED Decision Support
Arm Type
Experimental
Arm Description
Participants randomized to this arm of the study will receive the PREPARED educational book and video.
Intervention Type
Behavioral
Intervention Name(s)
PREPARED Decision Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Initiation of self-care dialysis or receipt of transplant
Description
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.
Time Frame
90 days after randomization
Title
Use of permanent vascular access
Description
Proportion of patients achieving initiation of RRT with a permanent vascular access.
Time Frame
90 days after randomization
Title
Emergent dialysis initiation
Description
Proportion of patients initiating dialysis urgently in the Emergency Room (versus planned initiation).
Time Frame
90 days after randomization
Title
Transplant evaluations, waiting list placement
Description
Proportion of patients achieving receipt of transplant evaluations, or placement on the kidney transplant waiting list prior to initiation.
Time Frame
90 days after randomization
Title
Blood pressure control at RRT initiation
Description
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.
Time Frame
90 days after randomization
Title
Anemia management
Description
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.
Time Frame
90 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh E. Boulware, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University / Nephrology Center Of Maryland / Good Samaritan Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23317336
Citation
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.
Results Reference
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PubMed Identifier
23198793
Citation
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.
Results Reference
background
PubMed Identifier
22645225
Citation
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.
Results Reference
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Providing Resources to Enhance Patients' Readiness to Make Decisions About Kidney Disease: The PREPARE NOW Study

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