Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Putting Patients at the Center of Kidney Care Transitions (PREPARE NOW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02722382
Recruitment Status : Enrolling by invitation
First Posted : March 30, 2016
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Geisinger Clinic
Johns Hopkins University
University of South Carolina
Information provided by (Responsible Party):
Duke University

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Patient-Centered Kidney Transitions Care Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. Change in number of Hospitalizations [ Time Frame: Baseline, 36 months ]
    Change in number of Hospitalizations

  3. Change in % patients with advance directives for kidney care [ Time Frame: Baseline, 36 months ]
    Change in % patients with advance directives for kidney care


Secondary Outcome Measures :
  1. Change in % self-care patients with biomedical care plans [ Time Frame: Baseline, 36 months ]
    Change in % self-care patients with biomedical care plans

  2. Change in % patients with values aligned care [ Time Frame: Baseline, 36 months ]
    Change in % patients with values aligned care

  3. Change in % patients with preferences for renal replacement therapy documented [ Time Frame: Baseline, 36 months ]
    Change in % patients with preferences for renal replacement therapy

  4. Change in % patients with emergency dialysis initiation [ Time Frame: Baseline, 36 months ]
    Change in % patients with emergency dialysis initiation

  5. Change in months to kidney failure [ Time Frame: Baseline, 36 months ]
    Change in months to kidney failure

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently receiving care at Geisinger nephrology practices
  • Age 18 and older
  • Advanced Kidney disease (determined by estimated glomerular filtration rates (eGFR) or presence of albuminuria)

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21210
Sponsors and Collaborators
Duke University
Geisinger Clinic
Johns Hopkins University
University of South Carolina
Investigators
Layout table for investigator information
Principal Investigator: Leigh E Boulware, MD Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02722382     History of Changes
Other Study ID Numbers: Pro00074588
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Chronic Kidney Disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency