Putting Patients at the Center of Kidney Care Transitions (PREPARE NOW)
NCT02722382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1572
Last updated 2024-03-25
Summary
Objective: The investigators will change the health system to improve care patients receive as they transition through earlier stages of kidney disease toward kidney failure. They will study whether these changes lead to patients' improved health and well-being.
Methods: The investigators will conduct this study in Geisinger Health System kidney specialty clinics. The study will implement 'Patient Centered Kidney Transitions Care' which will (1) give doctors tools to help them recognize when patients should prepare for kidney failure and help them support patients' early and informed treatment decisions; and (2) add a 'Kidney Transitions Specialist' to the health care team to help patients learn about kidney disease, learn self-care skills, make informed decisions, get psychosocial support, and coordinate their care. Four (4) clinics will be randomly assigned to provide Patient Centered Kidney Transitions Care, and four (4) to provide their usual care. The investigators will study differences in patients' outcomes among those treated in clinics providing Patient Centered Kidney Transitions Care compared to those treated in clinics providing usual care.
Patient Outcomes: Patients have told us they want to have 'control' over their disease transitions and to have the best quality of life possible. The investigators will measure patients' empowerment, confidence with their self-care, their decisions to start self-care treatments for kidney failure, and their hospitalizations. They will also measure whether doctors record patients' treatment preferences in the medical record before patients develop kidney failure.
Patient and Stakeholder Engagement: This study responds to reports from hundreds of patients and caregivers who want better care. Patients and caregivers from around the US are part of our investigative team, and they will participate in all aspects of our study. The investigators are also engaging key stakeholders in the kidney community, including patients, providers, payers, and regulators.
Anticipated Impact: If effective, Patient Centered Kidney Transitions Care will provide a model of care can improve the lives of patients and families with kidney disease across the US.
Conditions
Interventions
- OTHER
-
Patient-Centered Kidney Transitions Care
In a multi-faceted pragmatic approach, the intervention will 1) implement new electronic health information tools to help providers recognize patents in need of Kidney Transitions Care and focus their attention on patients' values and treatment preferences; and 2) implement a Kidney Transitions Specialist who will provide and facilitate integrated delivery of patient support programs that provide patients with knowledge, skills, and assistance to manage their disease, make high-quality treatment decisions, obtain needed psychosocial support, and navigate complex treatment plans.
Sponsors & Collaborators
-
Geisinger Clinic
collaborator OTHER - collaborator OTHER
-
University of South Carolina
collaborator OTHER - lead OTHER
Principal Investigators
-
Leigh E Boulware, MD · Duke University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-31
- Primary Completion
- 2020-10-30
- Completion
- 2020-10-31
Countries
- United States
Study Locations
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