Expanding and Promoting Alternative Care and kNowledge in Decision-making Trial

The goal of this clinical trial is to compare two health system-based approaches for offering kidney failure treatment options to older patients with kidney failure, specifically, to ensure patients are actively involved in a shared decision making (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 (ATPs): active medical care without dialysis, time-limited trial of dialysis, palliative dialysis, and deciding not to decide.

Approach 1 - Educate and Engage:

Nephrology practices 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 SDM with staff trained in communication skills and best practices.

Approach 2 - Educate and Engage Plus Kidney Supportive Care Program:

Nephrology practices add a primary palliative care program to support patients who choose ATPs and their families. The program provides care coordination, symptom management, advance care planning, and psychosocial support to supplement usual care from their nephrologist.

To compare the two approaches, the investigators will conduct a repeated, cross-sectional stepped wedge cluster randomized trial involving 20-25 chronic kidney disease clinics at 8 practice organizations around the United States.

Aim 1: Compare the effectiveness of Approaches 1 and 2 in a) increasing proportion of patients choosing ATP and b) reducing patient-reported decisional conflict about treatment.

Aim 2: Compare the patient and family experience of ATP care between Approaches 1 and 2 in terms of quality of life, services used, and end of life (EOL) experience. Aim 2a will focus on experience while patients are receiving an ATP. Aim 2b will describe the EOL experience.

Aim 3: Evaluate implementation of each approach through a mixed-methods design based on the expanded RE-AIM framework.

For Aims 1 and 2, researchers will collect information by chart review and surveys with patients and caregivers. For Aim 3, information will be reported by site managers as part of monthly progress reports. Clinic administrators, clinical providers, and staff will complete surveys before and after implementation of each approach.

Detailed Description

Background: Over 130,000 patients with kidney failure start dialysis annually (USRDS, 2018). Older patients constitute the fastest growing segment (USRDS, 2018). Those who are frail or have other serious medical conditions may not live any longer with dialysis than without it (Chandna et al, 2011). 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 (Saeed et al, 2020). 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), palliative dialysis, or deciding not to decide (DND) until a later date.

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 (Murtagh et al., 2016). 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 (Renal Physicians Association, 2010). Despite the recommendation and preference for SDM of people with advanced chronic kidney disease (CKD) (Davison, S.N., 2010; Morton et al., 2010), it remains poorly implemented, and observers have noted a powerful dialysis default with few perceived alternatives (Wong et al., 2018). 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 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), palliative dialysis, and deciding not to decide (DND).

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 20-25 chronic kidney disease clinics at 8 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. Accrual of new patients stops during a 4-month follow-up period (to collect primary outcomes) before each sequence moves to Approach 2 and 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.

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 a) increasing proportion of patients choosing ATP and b) reducing patient-reported decisional conflict.

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 caregivers. 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.

Study Activities and Data Collection for Aim 1

• Patients 65 years of age or older will be enrolled when their eGFR drops below 20.
• Patients are invited to take a series of three surveys that include the Decision Conflict Scale (OConnor, et al, 1995), Knowledge Assessment Scale (Ladin et al., 2023), and patient experience of shared decision-making using SDM-Q-9 (Scholl et al, 2010), CollaboRATE(Elwyn et al., 2013) , 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 4 months after enrollment.

Study Activities and Data Collection for Aim 2 - Patients who choose an ATP

• The RC conducts a monthly chart audit for each patient who chooses an alternative treatment plan. The audit assesses the number of clinic visits, hospitalizations, changes in treatment plans, and unplanned dialysis starts.
• A small open cohort of ATP patients and their family members/care partners are invited to participate in a longitudinal series of interviews about their experience of care under an ATP, starting at the time of treatment decision and continuing every 4 months until the end of the study or death of the patient.
• For ATP 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 ATP patients are invited to participate in bereavement interviews 4 months after patient death.

Study Activities and Data Collection for Aim 3

• The clinical site manager remains in frequent communication with local principal investigators and other project champions and submits monthly reports summarizing the adoption, reach, and fidelity of implementation at each clinic site
• Clinic administrators, clinicians, and staff are invited to participate in surveys and interviews before and after the implementation of each intervention approach.