Expanding and Promoting Alternative Care and kNowledge in Decision-making Trial
NCT ID: NCT06243068
Last Updated: 2025-07-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ENROLLING_BY_INVITATION
Clinical Phase
NA
Total Enrollment
3000 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-11-13
Study Completion Date
2028-06-01
Brief Summary
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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, clinic administrators, clinical providers, and staff will complete pre- and post-test surveys at the beginning and end of each training.
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, clinic administrators, clinical providers, and staff will complete pre- and post-test surveys at the beginning and end of each training.
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Detailed Description
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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), 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. 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 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. 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.
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. 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, Knowledge Assessment Scale, and patient experience of shared decision-making using SDM-Q-9, CollaboRATE, 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 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
• Clinic administrators, clinicians, and staff are invited to participate in pre-and post-test surveys at beginning and end of training.
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), 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. 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 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. 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.
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. 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, Knowledge Assessment Scale, and patient experience of shared decision-making using SDM-Q-9, CollaboRATE, 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 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
• Clinic administrators, clinicians, and staff are invited to participate in pre-and post-test surveys at beginning and end of training.
Conditions
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Chronic Kidney Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
We will use a repeated cross-sectional stepped wedge design with randomization at the practice level.
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Educate and Engage
Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 1.
Group Type
EXPERIMENTAL
Educate and Engage
Intervention Type
BEHAVIORAL
Nephrology practices implement a bundle in which they 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.
Educate and Engage Plus Kidney Supportive Care Program
Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 2.
Group Type
EXPERIMENTAL
Educate and Engage Plus Kidney Supportive Care Program
Intervention Type
BEHAVIORAL
In addition to bundle described under "Educate and Engage," nephrology practices 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.
Interventions
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Educate and Engage
Nephrology practices implement a bundle in which they 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.
Intervention Type
BEHAVIORAL
Educate and Engage Plus Kidney Supportive Care Program
In addition to bundle described under "Educate and Engage," nephrology practices 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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Age 65 years or older
* Most recent eGFR \<30 at time of screening AND meets practice site criteria for KDE referral
* Treatment naïve (no dialysis or kidney transplant prior to enrollment)
* Family member or caregiver of Population 1 patient who has chosen alternative treatment plan
* 18+ years old
* English or Spanish speaking
* Cognitively able to participate in surveys/interviews
Study Population 3: Administrator, clinical provider, or staff at participating chronic kidney disease clinic
\- Currently practicing or employed at participating clinic
* Most recent eGFR \<30 at time of screening AND meets practice site criteria for KDE referral
* Treatment naïve (no dialysis or kidney transplant prior to enrollment)
* Family member or caregiver of Population 1 patient who has chosen alternative treatment plan
* 18+ years old
* English or Spanish speaking
* Cognitively able to participate in surveys/interviews
Study Population 3: Administrator, clinical provider, or staff at participating chronic kidney disease clinic
\- Currently practicing or employed at participating clinic
Exclusion Criteria
* The patient is a transplant candidate.
* The current decrease in eGFR is thought to be due to an acute event.
* Education and initiation of shared decision-making process are not yet indicated for the patient, (per practice protocol and/or provider's judgment).
\- Insufficient decision making capacity (Outcomes for this group will be described separately.)
* Insufficient decision making capacity
* Non-English and non-Spanish speaking
* Treating nephrologist/APP opts patient out (for example, if contraindicated for patient's health)
Study Population 2: Family member or caregiver of patient in Study Population 1
* The current decrease in eGFR is thought to be due to an acute event.
* Education and initiation of shared decision-making process are not yet indicated for the patient, (per practice protocol and/or provider's judgment).
\- Insufficient decision making capacity (Outcomes for this group will be described separately.)
* Insufficient decision making capacity
* Non-English and non-Spanish speaking
* Treating nephrologist/APP opts patient out (for example, if contraindicated for patient's health)
Study Population 2: Family member or caregiver of patient in Study Population 1
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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West Virginia University Research Corporation
UNKNOWN
Sponsor Role
collaborator
University of Bristol
OTHER
Sponsor Role
collaborator
Patient-Centered Outcomes Research Institute
OTHER
Sponsor Role
collaborator
George Washington University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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UCSF/Zuckerberg San Francisco General Hospital and Trauma Center-Nephrology
San Francisco, California, United States
Site Status
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Site Status
Southeast Kidney Associates
Canton, Georgia, United States
Site Status
Southeast Kidney Associates
East Point, Georgia, United States
Site Status
St. Clair Nephrology
Shelby, Michigan, United States
Site Status
The Rogosin Institute Manhattan Eat Dialysis
New York, New York, United States
Site Status
Clinical Renal Associates
Exton, Pennsylvania, United States
Site Status
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Site Status
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Site Status
Renal Disease Research Institute
Dallas, Texas, United States
Site Status
Renal Disease Research Institute
Fort Worth, Texas, United States
Site Status
Renal Disease Research Institute
Garland, Texas, United States
Site Status
Renal Disease Research Institute
Irving, Texas, United States
Site Status
North Texas Kidney Disease Associates
Lewisville, Texas, United States
Site Status
Renal Disease Research Institute
McKinney, Texas, United States
Site Status
Renal Disease Research Institute
McKinney, Texas, United States
Site Status
Renal Disease Research Institute
Mesquite, Texas, United States
Site Status
North Texas Kidney Disease Associates
North Richland Hills, Texas, United States
Site Status
North Texas Kidney Disease Associates
Plano, Texas, United States
Site Status
Renal Disease Research Institute
Plano, Texas, United States
Site Status
Virginia Nephrology Group
Alexandria, Virginia, United States
Site Status
Virginia Nephrology Group
Arlington, Virginia, United States
Site Status
Virginia Nephrology Group
Fairfax, Virginia, United States
Site Status
West Virginia University Medicine
Fairmont, West Virginia, United States
Site Status
West Virginia University Medicine
Morgantown, West Virginia, United States
Site Status
Countries
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United States
References
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
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Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IHS-2022C2-27678
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NCR235148
Identifier Type: -
Identifier Source: org_study_id
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