Improving Shared Decision-Making and Access to Non-Dialytic Treatment for People With Kidney Disease (The ExPAND Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 3,000
- 试验地点
- 37
- 主要终点
- Decisional Conflict Scale score
研究概览
简要总结
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, surveys, and interviews with patients and care partners. For Aim 3, clinic administrators, clinical providers, and staff will complete pre- and post-test surveys at the beginning and end of each training.
详细描述
Detailed Description
Background: Over 130,000 patients with kidney failure start dialysis annually. Older patients constitute the fastest growing segment. Those who are frail or have other serious medical conditions may not live any longer with dialysis than without it. US healthcare policy has created a powerful "dialysis default," where virtually all patients with kidney failure who do not receive a transplant are treated with a standard dialysis regimen in a dialysis center regardless of whether it will help them live any longer or better. About 20% of patients regret the decision to start dialysis, yet non-dialysis alternatives are rarely offered to them. Most patients report they were unaware they had a choice about kidney failure treatment. Many older patients with kidney disease value independence over staying alive longer. Not aware of their patients' values, most nephrologists do not offer alternatives to standard dialysis such as active medical care without dialysis (AMCWD), a time-limited trial of dialysis (TLT), and palliative dialysis.
Similarly, these options, which the investigators have collectively labeled alternative treatment plans (ATPs), are rarely included in kidney disease education (KDE) sessions for patients funded by Medicare. Other countries-notably Australia, Canada, and the United Kingdom-have found that about 15% of older patients with kidney failure prefer AMCWD. These countries have created programs within their healthcare systems that integrate primary palliative care into care for patients who choose an ATP. These programs report excellent outcomes in terms of patient quality of life, care according to patient's wishes, and patient survival on average for over a year. These programs have shown it is possible to avoid complications at the end of life such as patients who wanted AMCWD being started on dialysis because their symptoms were not well managed. These programs provide an extra layer of support and prepare patients and families for when the patient's kidney failure worsens.
Shared decision-making (SDM) is recognized as the preferred approach to implementing patient-centered care and assuring that patients receive treatment that matches their goals. For over a decade, SDM has been recommended by nephrology professional societies before initiating dialysis. Despite the recommendation and preference for SDM of people with advanced chronic kidney disease (CKD), it remains poorly implemented, and observers have noted a powerful dialysis default with few perceived alternatives. There is an urgent need for strategies to increase adoption and implementation of SDM in nephrology practices and elsewhere in healthcare systems where CKD patients receive care.
Objective: The goal of this clinical trial is to compare two health system-based approaches (interventions) for offering kidney failure treatment options to older patients with kidney failure. Specifically, the goal is to ensure patients with kidney failure are actively involved in a SDM process covering a full range of treatment choices and have meaningful access to that full range of choices. These include standard in-center or home dialysis as well as alternative treatment plans: active medical management without dialysis (AMCWD), time-limited trial of dialysis (TLT), and palliative dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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 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 care partner of patient in Study Population 1
- •Inclusion Criteria:
- •Family member or care partner 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
研究组 & 干预措施
Educate and Engage
Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 1.
干预措施: Educate and Engage (Behavioral)
Educate and Engage Plus Kidney Supportive Care Program
Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 2.
干预措施: Educate and Engage Plus Kidney Supportive Care Program (Behavioral)
结局指标
主要结局
Decisional Conflict Scale score
时间窗: Month 4 after enrollment.
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).
Proportion of patients choosing Alternative Treatment Plans (ATP)
时间窗: Month 4 after enrollment.
Numerator: number of patients choosing an alternative treatment plan. Denominator: enrolled patients with decision-making capacity.
Decisional Conflict Scale score
时间窗: Month 4 after enrollment.
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).
次要结局
- For ATP patients, advance care planning (ACP) documentation at time of death.(Time of death. Collected 3 months after patient death.)
- Proportion of eligible clinicians who increase the proportion of patients choosing ATP(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)(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(Reported monthly by site manager in monthly progress reports, assessed from start to end of study, up to 40 months)
- Rating of CKD Knowledge Among Older Adults (Know-CKD) score(Four months after enrollment.)
- CollaboRATE score(Month 4 after enrollment.)
- Patient reported decision regret(Month 9 after enrollment.)
- Advance care planning (ACP) documentation(Month 4 after enrollment.)
- Proportion of Active Medical Care Without Dialysis (AMCWD) patients who change to dialysis at any time(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(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(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(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.(Time of death. Collected 3 months after patient death.)
- Proportion of eligible clinicians who engage patients in Shared Decision Making (SDM)(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(Reported monthly by site manager in monthly progress reports, assessed from start to end of study, up to 40 months)
- Rating of CKD Knowledge Among Older Adults (Know-CKD) score(Four months after enrollment.)
- Patient reported decision regret(Month 9 after enrollment.)
- Advance care planning (ACP) documentation(Month 4 after enrollment.)
- Shared Decision Making Questionnaire (SDM-Q-9) score(Month 4 after enrollment.)
- Proportion of eligible practice sites that offer Kidney Disease Education (KDE)(Reported monthly by site manager in monthly progress reports, assessed from start to end of study, up to 40 months)
- CollaboRATE score(Month 4 after enrollment.)
- Proportion of Active Medical Care Without Dialysis (AMCWD) patients who change to dialysis at any time(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(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(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(Final 30 days of life, (60 days and 90 days for sensitivity analysis). Assessed 3 months after patient death.)
- Proportion of eligible practice sites that offer Kidney Supportive Care (KSC) program(Reported monthly by site manager in monthly progress reports, assessed from start to end of study, up to 40 months)