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

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.