Home-Based Care for Advanced Kidney Disease

Recruiting in Palo Alto (17 mi)

Overseen by Susan Wong, MD MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Maintenance dialysis, HBPC program, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a randomized pilot study to test the feasibility and acceptability of a novel conservative care (CC) pathway among patients with advanced chronic kidney disease (CKD) who have chosen to forgo initiation of maintenance dialysis, their caregivers and providers.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Comprehensive Conservative Care for advanced kidney disease?

Research suggests that Comprehensive Conservative Care (CCC) can be a valid alternative to dialysis for certain patients with advanced kidney disease, particularly older individuals. Studies indicate that CCC may offer similar survival outcomes and potentially better quality of life compared to dialysis, focusing on symptom management and supportive care.

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Is home-based care for advanced kidney disease safe for humans?

The research on conservative care for kidney disease, which includes home-based care, suggests it is a viable and safe alternative to dialysis for some patients, particularly older ones, with advanced kidney disease.

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How is the Home-Based Care for Advanced Kidney Disease treatment different from other treatments?

This treatment, known as Comprehensive Conservative Care, is unique because it focuses on managing advanced kidney disease without dialysis, emphasizing quality of life and home-based care. It involves a holistic approach with a multidisciplinary team to support patients and caregivers, aiming to slow disease progression and prevent complications.

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Eligibility Criteria

This trial is for patients with advanced chronic kidney disease who have decided not to start maintenance dialysis. It's a pilot study to see if a new conservative care pathway works well and is accepted by patients, their caregivers, and healthcare providers.

Inclusion Criteria

Patients with agreement from their VA primary +/- nephrology care provider to participate in the study

I am unsure or do not want to start long-term dialysis.

I have chosen a caregiver who agrees to be part of the study with me.

Exclusion Criteria

Patients currently enrolled in the HBPC Program

Caregivers unable to complete the 'teach-back' method of informed consent

Patients unable to complete the 'teach-back' method of informed consent

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Kidney Care at Home Program through the existing HBPC infrastructure, involving multidisciplinary care and regular assessments.

12 months

Quarterly clinical encounters, monthly MDC meetings

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including interviews and surveys to assess quality of life and care satisfaction.

12 months

Participant Groups

The intervention being tested is a novel conservative care (CC) program designed as an alternative to regular dialysis treatment for those with severe kidney issues. The study randomly assigns participants to receive this CC program at home.

Group I: CC Program Received Intervention Experimental Treatment 1 Intervention

The CC Program will be delivered through the existing HBPC infrastructure at VA Puget Sound Health Care System. Each HBPC team is comprised on a lead physician or nurse practitioner, nurse, pharmacist, nutritionist, social worker, psychologist, therapist, and chaplain. At a minimum, subsequent clinical encounters and assessments for each Veteran will be scheduled no less than on a quarterly basis and more often as needed based on the HBPC team's clinical judgment. On a monthly basis, the entire HBPC team will conduct MDC meetings to review each Veteran's medical plan. The Program aims to provide patient-centered, whole-person and team-based care, shared decision-making, active symptom management, advance care planning and end-of-life care.

Group II: Usual Care Active Control 1 Intervention

Does not receive intervention.

CC Program is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Conservative Care for:

• Advanced Chronic Kidney Disease (CKD)
• End-Stage Renal Disease (ESRD)

🇺🇸 Approved in United States as Conservative Care for:

• Advanced Chronic Kidney Disease (CKD)
• End-Stage Renal Disease (ESRD)

🇨🇦 Approved in Canada as Conservative Care for:

• Advanced Chronic Kidney Disease (CKD)
• End-Stage Renal Disease (ESRD)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle, WA

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Survival of patients who opt for dialysis versus conservative care: a systematic review and meta-analysis. [2022] Non-dialytic conservative care (CC) has been proposed as a treatment option for patients with kidney failure. This systematic review and meta-analysis aims at comparing survival outcomes between dialysis and CC in studies where patients made an explicit treatment choice.

2. England pubmed.ncbi.nlm.nih.gov

Predicting mortality risk on dialysis and conservative care: development and internal validation of a prediction tool for older patients with advanced chronic kidney disease. [2022] Conservative care (CC) may be a valid alternative to dialysis for certain older patients with advanced chronic kidney disease (CKD). A model that predicts patient prognosis on both treatment pathways could be of value in shared decision-making. Therefore, the aim is to develop a prediction tool that predicts the mortality risk for the same patient for both dialysis and CC from the time of treatment decision.

3. Australia pubmed.ncbi.nlm.nih.gov

Characterising patients and clinician experiences in comprehensive conservative care for kidney failure in Northern Queensland. [2023] Comprehensive conservative care (CCC) is an emerging treatment option in kidney failure (KF), but its implementation has been restricted by a limited understanding of KF populations, outcomes and clinician experiences.

4. England pubmed.ncbi.nlm.nih.gov

Health-related quality of life and symptoms of conservative care versus dialysis in patients with end-stage kidney disease: a systematic review. [2021] Non-dialytic conservative care (CC) has been proposed as a viable alternative to maintenance dialysis for selected older patients to treat end-stage kidney disease (ESKD). This systematic review compares both treatment pathways on health-related quality of life (HRQoL) and symptoms, which are major outcomes for patients and clinicians when deciding on preferred treatment.

5. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Conservative Care in End-Stage Kidney Disease. [2021] In patients with end-stage kidney disease (ESKD), when there maybe situations where dialysis does not offer benefits in terms of survival or health-related quality of life, dialysis should not be viewed as the default therapy. Such patients can be offered comprehensive conservative care as an alternative to dialysis. Conservative (nondialytic) management of ESKD includes careful attention to fluid balance, treatment of anemia, correction of acidosis and hyperkalemia, blood pressure, and calcium/phosphorus metabolism management and dietary modification. Individualized symptom management and supportive care are crucial to maximize the quality of life. We propose that model of comprehensive conservative care in ESKD should manage both diseases as well as provide supportive care. Facilitating implementation of comprehensive conservative care requires coordination between nephrology and palliative care at patient, professional, administrative, and social levels to maximize benefit with the motto to improve the overall quality of life.

6. England pubmed.ncbi.nlm.nih.gov

Choosing Conservative Care in Advanced Chronic Kidney Disease - Patients' Perspectives. [2023] Conservative care (CC) is a viable treatment option for some patients with kidney failure. Choosing between dialysis and CC can be a complex decision, in which involvement of patients is desirable. Gaining insight into the experiences and preferences of patients regarding this decision-making process is an important initial step to improve care. We aimed to identify what is known about the perspective of patients regarding decision-making when considering CC.

7. France pubmed.ncbi.nlm.nih.gov

Comprehensive conservative care for the management of advanced chronic kidney disease [2023] Comprehensive “conservative care” is defined as any active therapeutic procedure for the management of stage 5 chronic kidney disease without recourse to dialysis. This therapeutic option is discussed in elderly, frail patients whose anticipated life expectancy is reduced with dialysis. The decision for conservative management primarily relies on an informed choice by the patient and his caregivers. This holistic approach, focused on quality of life, requires a multidisciplinary approach. The goals are to slow the progression of kidney disease, prevent complications, anticipate the risks of decompensation, provide support for the patient and his caregivers to maintain the best possible quality of life at home. This article describes the principles of conservative management, highlights various barriers to this care pathway, and proposes potential solutions.

8. Switzerland pubmed.ncbi.nlm.nih.gov

Home Palliative Care for Patients with Advanced Chronic Kidney Disease: Preliminary Results. [2023] Healthcare for patients with advanced chronic kidney disease (ACKD) on conservative treatment very often poses healthcare problems that are difficult to solve. At the end of 2011, we began a program based on the care and monitoring of these patients by Primary Care Teams. ACKD patients who opted for conservative treatment were offered the chance to be cared for mainly at home by the Primary Care doctor and nurse, under the coordination of the Palliative Care Unit and the Nephrology Department. During 2012, 2013, and 2014, 76 patients received treatment in this program (mean age: 81 years; mean Charlson age-comorbidity index: 10, and mean glomerular filtration rate: 12.4 mL/min/1.73 m²). The median patient follow-up time (until death or until 31 December 2014) was 165 days. During this period, 51% of patients did not have to visit the hospital's emergency department and 58% did not require hospitalization. Forty-eight of the 76 patients died after a median time of 135 days in the program; 24 (50%) died at home. Our experience indicates that with the support of the Palliative Care Unit and the Nephrology Department, ACKD patients who are not dialysis candidates may be monitored at home by Primary Care Teams.