Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02722382 |
Other study ID # |
Pro00074588 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 31, 2017 |
Est. completion date |
October 31, 2020 |
Study information
Verified date |
March 2024 |
Source |
Duke University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Background and Significance
Chronic kidney disease affects 20 million US adults who experience multifold excess morbidity
and mortality compared to the general public. Over 115,000 patients develop kidney failure
each year. For these patients, disease is often accompanied by unpredictable rapid rates of
kidney function decline in its later stages. Unpredictable declines in kidney function
commonly result in poorly planned transitions from seemingly stable chronic disease
management to urgent or emergent needs for kidney failure treatments. These sudden
transitions are often medically and psychologically traumatic for patients. Without advance
planning and support, most patients initiate dialysis emergently, and they are unprepared to
undergo substantial life changes and disability associated with treatments such as
thrice-weekly hemodialysis. They also miss important early opportunities to select treatments
(e.g., self care dialysis at home or kidney transplants) that could align with their values
and improve their health.
Since it is difficult to predict who will suddenly develop kidney failure, all patients with
later stage CKD should (a) be equipped to manage risks for disease progression and (b) learn
about treatment options for kidney failure with enough time to understand and plan for
possible treatments. Plans for some treatments, such as kidney transplant, are complex,
requiring multiple referrals, diagnostic tests, and medical visits. The loss of kidney
function is also, in some cases, accompanied by cognitive decline or by emotional
disturbances (including denial, fear, or depression). As a result, patients need time to
assimilate information and support to help them make informed decisions, coordinate their
care, and obtain psychosocial help.
Health system support for patients' kidney disease transitions is often inadequate. As a
result, patients have poor understanding of kidney disease treatments, feel care is not
patient centered, and are 'blind-sided' by the seemingly catastrophic initiation of
dialysis-- causing suffering and receipt of treatments they don't want. Efficacious
educational, psychosocial, and care management interventions exist, but they are implemented
in piecemeal fashion and are not readily accessible. Health system infrastructure and
resources enabling integrated delivery of efficacious interventions may be the crucial
missing link to ensuring patients' are supported through their to kidney failure and to
improving their health and well-being.
Study Aims
The investigators seek to improve health systems' capacities to provide comprehensive care
for patients as they transition from chronic kidney disease to kidney failure. Specifically,
they will:
1. Establish a Patient Centered Kidney Transitions Care infrastructure that (a) prioritizes
kidney patients' informed self-care and treatment decisions and (b) supports patients
through their transitions across kidney disease stages by providing education,
psychosocial support, and biomedical preparation
2. Study the effectiveness of the new Patient Centered Kidney Transitions Care
infrastructure to improve patients' values-aligned kidney care, empowerment, and
well-being
Study Description
The investigators will perform a cluster randomized controlled trial among 8 nephrology
clinics in Geisinger Health System. Clinics provide nephrology care for over 2.6 million
patients in 44 rural and suburban counties in eastern Pennsylvania. The study will target
adults (age >18 years) with estimated glomerular filtration rates of <30 ml/min/1.73m2 or
increased risk of disease progression. Practice populations are substantially rural with
moderate to low education and advanced age. Practices serve 997 patients, and we anticipate
498 patients in each arm (each arm comprised of 4 practices).
In four clinics, the investigators will implement 'Patient Centered Kidney Transitions Care'.
This intervention will implement two major health system changes, including (1) new
electronic health information tools to alert providers when patients need kidney transitions
care and to help them establish patients' preference aligned care; and (2) add a 'Kidney
Transitions Specialist' to the health care team plus resources to support patients'
transitions. Electronic health information tools will include (a) a disease registry and
personalized risk prediction tools to prompt physicians when patients need transitions
support and prepare patients for kidney failure when the time is right, and (b) a modular
computer application which will help patients enter their values and treatment preferences
into their own health records and help providers track their care. The Kidney Transitions
Specialist will (1) facilitate patients' education and engage in shared decision-making with
patients and caregivers; (2) empower patients to improve self-care through behavioral
training; (3) engage peer and professional social and emotional support; (4) navigate
patients through multi-step biomedical plans; and (5) advocate for aligning patients' care
with their values. We will compare outcomes in clinics implementing Patient Centered Kidney
Transitions Care to outcomes in four clinics that will proceed with routine nephrology care,
which does not include health information tools or changes to the health care team or
programs.
Primary outcomes will measure patients' empowerment, self-efficacy with self-care, decisions
to start self-care treatments, and hospitalizations. The investigators will also measure
documentation of patients' preferences in the electronic health record. These outcomes were
chosen because patients have told us they want to feel they have 'control' over their disease
and they want the best quality of life possible.
Long term, these findings will provide important information on how to improve the health and
well being of patients as they transition from chronic kidney disease to kidney failure. If
effective, this work will provide a model that can be replicated by health systems across the
US.