Expanding and Promoting Alternative Care and kNowledge in Decision-making Trial (ExPAND)

Improving Shared Decision-Making and Access to Non-Dialytic Treatment for People With Kidney Disease (The ExPAND 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, and palliative dialysis.

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 14 chronic kidney disease clinics at 7 practice organizations around the United States.

Aim 1: Compare the effectiveness of Approaches 1 and 2 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 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Behavioral: Educate and Engage; Behavioral: Educate and Engage Plus Kidney Supportive Care Program

Detailed Description

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 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.

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 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 AMCWD

• The RC conducts a monthly 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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • UCSF/Zuckerberg San Francisco General Hospital and Trauma Center-Nephrology
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Georgia
    • Canton, Georgia, United States, 30114
      • Southeast Kidney Associates
    • East Point, Georgia, United States, 30344
      • Southeast Kidney Associates
  • Michigan
    • Shelby, Michigan, United States, 48315
      • St. Clair Nephrology
  • New York
    • New York, New York, United States, 10021
      • The Rogosin Institute Manhattan Eat Dialysis
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Clinical Renal Associates
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman Center for Advanced Medicine
  • Texas
    • Dallas, Texas, United States, 75246
      • Renal Disease Research Institute
    • Fort Worth, Texas, United States, 76104
      • Renal Disease Research Institute
    • Garland, Texas, United States, 75044
      • Renal Disease Research Institute
    • Irving, Texas, United States, 75061
      • Renal Disease Research Institute
    • Lewisville, Texas, United States, 75057
      • North Texas Kidney Disease Associates
    • McKinney, Texas, United States, 75069
      • Renal Disease Research Institute
    • McKinney, Texas, United States, 75071
      • Renal Disease Research Institute
    • Mesquite, Texas, United States, 75150
      • Renal Disease Research Institute
    • North Richland Hills, Texas, United States, 76180
      • North Texas Kidney Disease Associates
    • Plano, Texas, United States, 75093
      • North Texas Kidney Disease Associates
    • Plano, Texas, United States, 75093
      • Renal Disease Research Institute
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Virginia Nephrology Group
    • Arlington, Virginia, United States, 22205
      • Virginia Nephrology Group
    • Fairfax, Virginia, United States, 22030
      • Virginia Nephrology Group
  • West Virginia
    • Fairmont, West Virginia, United States, 26554
      • West Virginia University Medicine
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Study Population 1: Person with CKD, cared for at participating clinic

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)

Exclusion Criteria:

• 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).

Exclusion Criteria for primary analysis:

- Insufficient decision making capacity (Outcomes for this group will be described separately.)

Exclusion Criteria for surveys and interviews:

• 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

Inclusion Criteria:

• Family member or caregiver of Population 1 patient who has chosen active medical care without dialysis and consented to decisional conflict surveys
• 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

Inclusion Criteria:

- Currently practicing or employed at participating clinic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educate and Engage; Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 1.	Behavioral: 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.
Experimental: Educate and Engage Plus Kidney Supportive Care Program; Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 2.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients choosing Alternative Treatment Plans (ATP)	Numerator: number of patients choosing an alternative treatment plan. Denominator: enrolled patients with decision-making capacity.	Month 4 after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional Conflict Scale score	Decisional Conflict Scale (O'Connor, 1995) score at month 4 survey, adjusted for baseline score. Score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict).	Month 4 after enrollment.
Rating of CKD Knowledge Among Older Adults (Know-CKD) score	Rating of CKD Knowledge Among Older Adults (Know-CKD) 4 months after initiation of treatment decision-making process. Decision-Aid for Renal Therapy (DART) Knowledge Assessment (Ladin et al., 2023). The DART survey contains 10 items scored on a 3 point scale, with 0 points given for an answer of yes, 2 for an answer of unsure, and 4 for an answer of no. The total score is the sum of the 10 items, multiplied by 2.5. The minimum score possible is 0 (no decisional conflict) and the maximum score possible is 100 (extremely high decisional conflict) (Month three score, adjusted for baseline score)	Four months after enrollment.
Shared Decision Making Questionnaire (SDM-Q-9) score	9-Item Shared Decision Making Questionnaire (SDM-Q-9) score (Scholl, 2010). Score ranges from 0 (least SDM) to 45 (most SDM).	Month 4 after enrollment.
CollaboRATE score	CollaboRATE score (Elwyn et al., 2013). Scores range from 0 (least SDM) to 9 (most SDM).	Month 4 after enrollment.
Advance care planning (ACP) documentation	Complete ACP measure (Three elements present in chart: a surrogate, a goals of care discussion, and either an accessible advance directive or medical order such as POLST or DNR.)	Month 4 after enrollment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Active Medical Care Without Dialysis (AMCWD) patients who change to dialysis at any time	Proportion of patients who initially choose AMCWD who subsequently switch to dialysis (standard in-center hemodialysis, home dialysis, time-limited trial, or palliative).	From date of initial treatment decision to date of changed treatment decision, start of dialysis, patient death or end of study, whichever came first, assessed up to 40 months.
Proportion of ATP patients who have an unplanned transition into dialysis	Proportion of patients who initially choose an ATP who subsequently have an unplanned dialysis start: defined as starting dialysis urgently in the hospital during an unscheduled admission.	From date of initial treatment decision to date of changed treatment decision, start of dialysis, patient death or end of study, whichever came first, assessed up to 40 months.
End of Life intensity scale	Modified scale adapted from Wong et al, 2012, based on health services received during the last month of life (dialysis, emergency department, hospital, ICU), and death in hospital. Scores range from 0-6 with a higher score indicating more intensive end-of-life care.	Final 30 days of life, (60 days and 90 days for sensitivity analysis). Assessed 3 months after patient death.
AMCWD & DND patients who initiate dialysis in the last month of life	Of AMCWD & DND patients die during the study, proportion who used dialysis in last 30 days of life.	Final 30 days of life, (60 days and 90 days for sensitivity analysis). Assessed 3 months after patient death.
For ATP patients, advance care planning (ACP) documentation at time of death.	Complete ACP measure (Three elements present in chart: a surrogate, a goals of care discussion, and either an accessible advance directive or medical order such as POLST or DNR.)	Time of death. Collected 3 months after patient death.
Proportion of eligible clinicians who engage patients in Shared Decision Making (SDM)	Proportion of eligible clinicians who engage patients in SDM. Demographic representativeness will be also be described.	Reported monthly by site manager in monthly progress reports, assessed from start to end of study, up to 40 months
Proportion of eligible clinicians who increase the proportion of patients choosing ATP	Proportion of eligible clinicians who increase the proportion of patients choosing ATP. Demographic representativeness will be also be described.	Reported monthly by site manager in monthly progress reports, assessed from start to end of study, up to 40 months
Proportion of eligible practice sites that offer Kidney Disease Education (KDE)	Proportion of eligible practice sites that offer KDE. Demographic representativeness will be also be described.	Reported monthly by site manager in monthly progress reports, assessed from start to end of study, up to 40 months
Proportion of eligible practice sites that offer Kidney Supportive Care (KSC) program	Proportion of eligible practice sites that offer KSC. Demographic representativeness will be also be described.	Reported monthly by site manager in monthly progress reports, assessed from start to end of study, up to 40 months
ATP patient reports of experience of ATP care (qualitative)	Responses to open-ended questions about the experience of receiving care under an alternative treatment plan. Reported by a convenience sample of patients who choose an ATP and participate in a longitudinal series of interviews.	Starts after consent to participate in longitudinal interviews. Repeats every 4 months until first of project completion or patient death, assessed up to 40 months.]
Caregiver reports of caregiving experience (qualitative)	Responses to open-ended questions of experience caring for patients who have selected ATP. Reported by a convenience sample of caregivers who have consented to participate in a longitudinal series of interviews.	Starts after consent to participate in longitudinal interviews. Repeats every 4 months until first of project completion or patient death, assessed up to 40 months.
Hospice use by ATP patients	Among ATP patients, proportion of deaths with hospice care, length of use of hospice.	End of life. Collected by chart review 3 months after death.
Proportion of eligible patients who enroll in the Kidney Supportive Care Program	Proportion of eligible patients (patients who choose an ATP under Approach 2) who enroll in the Kidney Supportive Care Program. Demographic representativeness will be also be described.	Reported monthly by site manager in monthly progress reports, assessed from start to end of study, up to 40 months
Patient reported decision regret	Modification of dialysis decision regret (Saeed et al., 2020) : Do you regret your treatment decision? 5-point Likert scale from 1 to 5, with 1 being "no regret at all" and 5 begin "a lot of regret".	Month 9 after enrollment.
McGill Quality of Life Part A Score	McGill Quality of Life score (Cohen et al., 1997). Based on responses to Part A, scores range from 0 (very bad) to 10 (excellent). Repeated measure, reported by a convenience sample of patients and care partners who choose an ATP and participate in a longitudinal series of interviews.	Starts after consent to participate in longitudinal interviews. Repeats every 4 months until first of project completion or patient death, assessed up to 40 months.
Caregiver reports of their experience of end-of-life care (qualitative)	Responses to open-ended questions of experience caring for patients who have selected ATP and have died. Reported by a convenience sample of caregivers who have consented to participate in a longitudinal series of interviews.	End of life. Bereavement interview conducted 4 months after patient death.
Decisional conflict scale subscale scores	Decisional Conflict Survey subscale (O'Connor, 1995) scores at month 4 survey, adjusted for baseline score. Score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict).	Month 4 after enrollment.

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: Patient-Centered Outcomes Research Institute; University of Bristol; West Virginia University Research Corporation

Publications and helpful links

General Publications

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• Koch-Weser S, Kennefick K, Tighiouart H, Wong JB, Gordon EJ, Isakova T, Rifkin D, Rossi A, Weiner DE, Ladin K. Development and Validation of the Rating of CKD Knowledge Among Older Adults (Know-CKD) With Kidney Failure. Am J Kidney Dis. 2024 May;83(5):569-577. doi: 10.1053/j.ajkd.2023.09.024. Epub 2023 Dec 7.
• Buur LE, Madsen JK, Eidemak I, Krarup E, Lauridsen TG, Taasti LH, Finderup J. Does conservative kidney management offer a quantity or quality of life benefit compared to dialysis? A systematic review. BMC Nephrol. 2021 Sep 11;22(1):307. doi: 10.1186/s12882-021-02516-6.
• Korevaar E, Kasza J, Taljaard M, Hemming K, Haines T, Turner EL, Thompson JA, Hughes JP, Forbes AB. Intra-cluster correlations from the CLustered OUtcome Dataset bank to inform the design of longitudinal cluster trials. Clin Trials. 2021 Oct;18(5):529-540. doi: 10.1177/17407745211020852. Epub 2021 Jun 4.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: CKD; ESRD; Palliative Care; Shared-Decision Making; Kidney Disease Education; Alternative Treatment Plan; KDE; Active Medical Management without Dialysis; Kidney Supportive Care; AMCWD
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: NCR235148; IHS-2022C2-27678 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After completion of the study, the completely deidentified research data from this project will be deposited with the digital repository, the Patient-Centered Outcomes Data Repository (PCODR), of the Inter-university Consortium for Political and Social Research (ICPSR), University of Michigan to ensure that the research community has long-term access to the data. This is required by PCORI and included in consent forms.
• IPD Sharing Time Frame: Per PCORI guidelines
• IPD Sharing Access Criteria: Per PCORI guidelines
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No