Putting Patients at the Center of Kidney Care Transitions (PREPARE NOW)
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|ClinicalTrials.gov Identifier: NCT02722382|
Recruitment Status : Enrolling by invitation
First Posted : March 30, 2016
Last Update Posted : February 27, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Other: Patient-Centered Kidney Transitions Care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Putting Patients at the Center of Kidney Care Transitions|
|Actual Study Start Date :||January 31, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2020|
No Intervention: Usual Nephrology Care
Nephrology care at Geisinger Health System.
Active Comparator: Patient-Centered Kidney Transitions Care
Health system intervention which will implement informatics tools (including a disease registry, predictive modeling, and advance directives) and a disease specific care manager who will provide services and navigate patients through kidney disease transitions.
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.
Other Name: PREPARE NOW
- Change in % patients feeling in control of their decision-making [ Time Frame: Baseline, 36 months ]Change in % patients feeling in control of their decision-making
- Change in number of Hospitalizations [ Time Frame: Baseline, 36 months ]Change in number of Hospitalizations
- Change in % patients with advance directives for kidney care [ Time Frame: Baseline, 36 months ]Change in % patients with advance directives for kidney care
- Change in % self-care patients with biomedical care plans [ Time Frame: Baseline, 36 months ]Change in % self-care patients with biomedical care plans
- Change in % patients with values aligned care [ Time Frame: Baseline, 36 months ]Change in % patients with values aligned care
- Change in % patients with preferences for renal replacement therapy documented [ Time Frame: Baseline, 36 months ]Change in % patients with preferences for renal replacement therapy
- Change in % patients with emergency dialysis initiation [ Time Frame: Baseline, 36 months ]Change in % patients with emergency dialysis initiation
- Change in months to kidney failure [ Time Frame: Baseline, 36 months ]Change in months to kidney failure
- Change in % patients with vascular access (e.g., fistula) in place at dialysis initiation [ Time Frame: 36 months ]Change in % patients with vascular access (e.g., fistula) in place at dialysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722382
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21210|
|Principal Investigator:||Leigh E Boulware, MD||Duke University|