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

Chronic Kidney Disease Clinical Trial

— ExPAND  

Official title:

Improving Shared Decision-Making and Access to Non-Dialytic Treatment for People With Kidney Disease (The ExPAND Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06243068
• Other study ID #: NCR235148
• Secondary ID: IHS-2022C2-27678
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: June 1, 2028

Study information

• Verified date: January 2024
• Source: George Washington University
• Contact: Joshua Mannix, MSc
• Phone: 5715530194
• Email: joshuajmannix[@]gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 28 chronic kidney disease clinics at 10 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.

Description:

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 AMMWD, a TLT, palliative dialysis, or DND until a later date.

Similarly, these options, which the investigators have collectively labeled ATPs, are rarely included in 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 AMMWD (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 AMMWD 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 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, shared decision-making (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 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 management without dialysis (AAMWD), 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.

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 10 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. 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. 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. 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.

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

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.

• Time 0 is when the kidney failure treatment decision process is initiated, (clinician begins SDM process and/or refers patient to KDE).

• Once the treatment decision process has been initiated (Time 0), patients are invited to take a series of three surveys that includes the Decision Conflict Scale (OConnor, et al, 1995) and Knowledge Assessment Scale (Ladin et al., 2023) . The baseline survey (DCS-0) is taken immediately. Follow-up surveys are conducted at Month 3 and Month 9 after Time 0.

• Patients are also invited to take a telephone survey, conducted by West Virginia University interviewers 4 months after Time 0. This survey measures patient experience of shared decision-making using SDM-Q-9 (Scholl et al, 2010), CollaboRATE(Elwyn et al., 2013) , and other assessments.

• The RA conducts a chart audit to look for advance care planning documentation 4 months after Time 0.

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

• The RA 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/caregivers 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 RA conducts a chart review to assess EOL service utilization and advance care planning.

• Caregivers of 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: June 1, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Inclusion Criteria:

• Age 65 years or older

• eGFR dropped below 20 at least once during past 12 months. (The patient is still eligible if there are some results just above this range, e.g., 20-25, at screening or during follow up.)

Exclusion Criteria:

• The eGFR measurement(s) below 20 are considered to be due to acute kidney injury by the clinical team.

• The patient is a candidate for kidney transplant

• KDE was initiated before screening. (The patient is still eligible if 1) KDE was initiated within the month before screening or 2) KDE occurred when eGFR >= 20.)

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)

• After eGFR < 20, KDE already attended (first survey only)

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 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

Inclusion Criteria:

• Currently practicing or employed at participating clinic

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Dallas Nephrology Associates	Dallas	Texas
United States	Ochsner Health	Jefferson	Louisiana
United States	West Virginia University Medicine	Morgantown	West Virginia
United States	The Rogosin Institute	New York	New York
United States	Renalcare Associate	Peoria	Illinois
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
George Washington University	Patient-Centered Outcomes Research Institute, University of Bristol, West Virginia University Research Corporation

Country where clinical trial is conducted

United States, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	McGill Quality of Life score	McGill Quality of Life score (Cohen et al., 1997). Based on responses to 16 items, scores range from 0 (worst quality of life) to 160 (best quality of life). Repeated measure, 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.
Other	Quality of Communication Questionnaire: general communication skills scale score	Engelberg Quality of Communication Questionnaire (Engelberg et al., 2006) 6-item general communications skills scale measures quality of doctor-patient communication. Scored as 0 (very worst possible) to 10 (very best possible). Repeated measure, 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.
Other	Quality of Communication Questionnaire: communication about end-of-life care scale score	Engelberg Quality of Communication Questionnaire (Engelberg et al., 2006) 7-item communication about end-of-life care scale measures quality of doctor-patient communication about end-of-life care. Scored as 0 (very worst possible) to 10 (very best possible). Repeated measure, 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.
Other	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.]
Other	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.
Other	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.
Other	Family rating of quality of care at end of life (EOL) and themes about it	Selected questions from Bereaved Family Survey (US Department of Veterans Affairs). Qualitative themes from interview.	End of life. Family members will be approached 4 months after death.
Other	Reach: Proportion of eligible patients who enroll in and complete KDE	Proportion of eligible patients who enroll in and complete 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
Other	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
Other	Implementation (fidelity)	Fidelity checklists	Assessed 3 times at each clinical site through study completion, once after initial training for approach 1, once during the month prior to starting approach 2, and once during the last month of the study
Other	Maintenance (Organizational)	Program sustainability assessment tool	Assessed 3 times at each clinical site through study completion, once after initial training for approach 1, once during the month prior to starting approach 2, and once during the last month of the study
Other	Acceptability (Organizational)	Acceptability of Intervention Measure and Semi-structured interviews	Assessed 3 times at each clinical site through study completion, once after initial training for approach 1, once during the month prior to starting approach 2, and once during the last month of the study
Other	Appropriateness (Organizational)	Intervention Appropriateness Measure and Semi-structured interviews	Assessed 3 times at each clinical site through study completion, once after initial training for approach 1, once during the month prior to starting approach 2, and once during the last month of the study
Other	Feasibility (Organizational)	Feasibility of Intervention Measure and Semi-structured interviews	Assessed 3 times at each clinical site through study completion, once after initial training for approach 1, once during the month prior to starting approach 2, and once during the last month of the study
Other	Inner Setting, Implementation Process, Individuals (Organizational)	Staff will be surveyed with questions like E.g., What types of additional support do you feel you most need to continue using shared decision- making? E.g., Are there people in your practice who are likely to champion the Kidney Supportive Care Program? E.g., How do you feel about the Kidney Disease Education being used in your clinic?	Assessed 2 times at each clinical site through study completion, once during the month prior to starting approach 2, and once during the last month of the study
Primary	Proportion of patients choosing Alternative Treatment Plans (ATP)	Numerator: number of patients choosing an alternative treatment plan. Denominator: enrolled patients with decision-making capacity.	From initiation of treatment decision-making process to four months later.
Primary	Decisional Conflict Scale score	Decisional Conflict Scale (O'Connor, 1995) score at month 3 survey, adjusted for baseline score. Score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict).	Month 3 after treatment decision-making process initiated.
Secondary	Rating of CKD Knowledge Among Older Adults (Know-CKD) score	Rating of CKD Knowledge Among Older Adults (Know-CKD) 3 months after initiation of treatment decision-making processDecision-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)	Three months after initiation of treatment decision-making process.
Secondary	Shared Decision Making Questionnaire (SDM-Q-9) score	9-Item Shared Decision Making Questionnaire (SDM-Q-9) score (Scholl, 2010) from telephone survey. Score ranges from 0 (least SDM) to 45 (most SDM).	Month 4 after treatment decision-making process initiated.
Secondary	CollaboRATE score	CollaboRATE score (Elwyn et al., 2013) from telephone survey. Scores range from 0 (least SDM) to 9 (most SDM).	Month 4 after treatment decision-making process initiated.
Secondary	Patient reported decision regret	Modification of dialysis decision regret (Saeed et al., 2020) : Do you regret your decision to start (treatment selected) elicited during telephone survey.	Month 4 after treatment decision-making process initiated.
Secondary	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 treatment decision-making process initiated.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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