Detailed Description
Background: Over 130,000 patients with kidney failure start dialysis annually. Older
patients constitute the fastest growing segment. Those who are frail or have other
serious medical conditions may not live any longer with dialysis than without it. US
healthcare policy has created a powerful "dialysis default," where virtually all patients
with kidney failure who do not receive a transplant are treated with a standard dialysis
regimen in a dialysis center regardless of whether it will help them live any longer or
better. About 20% of patients regret the decision to start dialysis, yet non-dialysis
alternatives are rarely offered to them. Most patients report they were unaware they had
a choice about kidney failure treatment. Many older patients with kidney disease value
independence over staying alive longer. Not aware of their patients' values, most
nephrologists do not offer alternatives to standard dialysis such as active medical care
without dialysis (AMCWD), a time-limited trial of dialysis (TLT), and palliative
dialysis.
Similarly, these options, which the investigators have collectively labeled alternative
treatment plans (ATPs), are rarely included in kidney disease education (KDE) sessions
for patients funded by Medicare. Other countries-notably Australia, Canada, and the
United Kingdom-have found that about 15% of older patients with kidney failure prefer
AMCWD. These countries have created programs within their healthcare systems that
integrate primary palliative care into care for patients who choose an ATP. These
programs report excellent outcomes in terms of patient quality of life, care according to
patient's wishes, and patient survival on average for over a year. These programs have
shown it is possible to avoid complications at the end of life such as patients who
wanted AMCWD being started on dialysis because their symptoms were not well managed.
These programs provide an extra layer of support and prepare patients and families for
when the patient's kidney failure worsens.
Shared decision-making (SDM) is recognized as the preferred approach to implementing
patient-centered care and assuring that patients receive treatment that matches their
goals. For over a decade, SDM has been recommended by nephrology professional societies
before initiating dialysis. Despite the recommendation and preference for SDM of people
with advanced chronic kidney disease (CKD), it remains poorly implemented, and observers
have noted a powerful dialysis default with few perceived alternatives. There is an
urgent need for strategies to increase adoption and implementation of SDM in nephrology
practices and elsewhere in healthcare systems where CKD patients receive care.
Objective: The goal of this clinical trial is to compare two health system-based
approaches (interventions) for offering kidney failure treatment options to older
patients with kidney failure. Specifically, the goal is to ensure patients with kidney
failure are actively involved in a SDM process covering a full range of treatment choices
and have meaningful access to that full range of choices. These include standard
in-center or home dialysis as well as alternative treatment plans: active medical
management without dialysis (AMCWD), time-limited trial of dialysis (TLT), and palliative
dialysis.
Interventions - Approach 1: Educate and Engage:
In this approach, nephrology practices implement a bundle in which the participants will
encourage their patients to a) participate in a kidney disease education program
providing a balanced presentation of all options including ATPs, b) use evidence-based
patient decision aids that include ATPs, and c) engage in shared decision-making with
staff who have been trained in communication skills and best practices.
Interventions - Approach 2: Educate and Engage Plus Kidney Supportive Care Program:
In this approach, nephrology practices continue to implement the Educate and Engage
bundle and additionally, offer a systematic program integrating primary palliative care
to support patients and their families who choose any ATP. The program closely follows
patients and their families on ATP with care coordination, symptom management, advance
care planning, and psychosocial support to supplement usual care from their nephrologist.
Study Design: To compare the two approaches, the investigators will conduct a repeated,
cross-sectional stepped wedge cluster randomized trial (SW-CRT) involving 14 chronic
kidney disease clinics at 7 practice organizations around the United States.
Participating clinical sites will be randomly placed into one of three sequences. Each
sequence consists of four 10-month time periods during which patients are accrued and
followed for study outcomes. All practices begin by implementing Approach 1 (Educate and
Engage). Practices then add Approach 2 (Kidney Supportive Care Program) at the assigned
period based on their sequence. To minimize contamination in the primary analysis, we
will exclude patients recruited during the 4 months before each sequence moves to
Approach 2. These patients will be included in a sensitivity analysis. In the 4th study
period, accrual of new patients will stop during a 4-month follow-up period (to collect
primary outcomes) at the end of the study. Patients will receive the intervention based
on the approach (condition) in which the site is enrolled at the time of accrual. When a
practice site begins implementation of Approach 2, referral to the kidney supportive care
program for patients considering ATPs will become standard care at that site. All
patients still alive who chose ATPs in prior periods will be offered the option of
receiving care from the newly organized supportive care program.
In addition to the primary SW-CRT comparing the two intervention approaches, the
investigators will do a pre-post comparison of primary outcomes, comparing clinic
practices at baseline with each of the interventions.
Research Aims:
Aim 1: Compare the effectiveness of two approaches: 1) improved kidney disease education
(KDE) and SDM or 2) improved KDE and SDM plus the creation of a kidney supportive care
program in increasing proportion of patients choosing ATP and explore comparative
effectiveness on patient reported outcomes of decisional conflict and shared
decision-making as well as health care utilization and advance care planning.
Aim 2: Compare the patient and family experience of an ATP between Approach 1 and
Approach 2 in terms of quality of life, services used, and end of life (EOL) experience
through medical record review and interviews with a sample of patients, family members,
and care partners. Aim 2a will focus on experience while patients are receiving an ATP
(several months to several years). Aim 2b will describe the EOL experience.
Aim 3: Evaluate implementation of each intervention (Approaches 1 and 2) through a
mixed-methods design based on the expanded RE-AIM framework, which integrates the
Implementation Outcomes Framework by positing that the implementation outcomes
acceptability (whether interventions are agreeable and satisfactory), appropriateness
(perceived fit, relevance, and compatibility), and feasibility (extent to which
interventions can be used successfully) are predictors of successful adoption,
implementation, and maintenance. The ExPAND research team will cooperate with a separate
tandem evaluation conducted by an independent evaluation team based at NORC.
Study Activities and Data Collection for Aim 1
Patients 65 years of age or older will be enrolled when their eGFR drops below 30.
Patients are invited to take a series of three surveys that include the Decision
Conflict Scale and other assessments. The baseline survey (DCS-1) is taken at the
time of enrollment. Follow-up surveys are conducted at Month 4 and Month 9 after
enrollment.
The research coordinator (RC) conducts a chart audit to look for advance care
planning documentation and current treatment preference 4 months after enrollment.
Study Activities and Data Collection for Aim 2 - Patients who choose an AMCWD
The RC conducts a quarterly chart audit for each patient who chooses active medical
care without dialysis. The audit assesses the number of clinic visits,
hospitalizations, changes in treatment plans, and unplanned dialysis starts.
A small open cohort of AMCWD patients and their family members/care partners are
invited to participate in a longitudinal series of interviews about their experience
of care under an AMCWD, starting at the time of treatment decision and continuing
every 4 months until the end of the study or death of the patient.
For AMCWD patients who die, the RC conducts a chart review to assess EOL service
utilization and advance care planning.
A purposeful sample of family members/care partners of AMCWD patients are invited to
participate in bereavement interviews 4 months after patient death.
Study Activities and Data Collection for Aim 3
• Clinic administrators, clinicians, and staff are invited to participate in pre-and
post-test surveys at beginning and end of training.
