Home-Based Care for Advanced Kidney Disease

Overseen By Rachel R Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Maintenance dialysis, HBPC program, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 3 4 7 8}

Research Team

Susan Wong, MD MS

Principal Investigator

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

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

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

Treatment Details

Interventions

• CC Program

Trial Overview 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.

Participant Groups

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)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A systematic review of 22 cohort studies involving 21,344 patients found that those who chose dialysis had a significantly lower risk of mortality compared to those who opted for non-dialytic conservative care (CC), with a pooled adjusted hazard ratio of 0.47.

Patients selecting dialysis were generally younger and healthier than those choosing CC, which may influence survival outcomes; however, the high risk of bias in the studies limits the ability to draw definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival of patients who opt for dialysis versus conservative care: a systematic review and meta-analysis. Voorend, CGN., van Oevelen, M., Verberne, WR., et al.[2022]

A prediction tool was developed to estimate 2-year mortality risk for older patients (≥70 years) with advanced chronic kidney disease (CKD) considering both conservative care (CC) and dialysis, based on data from 366 patients.

The tool showed moderate discrimination in predicting outcomes, with C-statistics ranging from 0.675 to 0.750, and good calibration, indicating it could help inform treatment decisions by providing individualized prognosis estimates for patients.

NCBI (Pubmed)

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. Ramspek, CL., Verberne, WR., van Buren, M., et al.[2022]

Patients opting for comprehensive conservative care (CCC) in kidney failure are generally more frail and have higher co-morbidities compared to those starting dialysis, indicating that CCC may be suitable for more vulnerable patients.

Clinicians reported low confidence in discussing CCC with patients, highlighting a need for better training and tools to facilitate these important treatment conversations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterising patients and clinician experiences in comprehensive conservative care for kidney failure in Northern Queensland. Al Maraee, G., Vangaveti, V., Mallett, A.[2023]

A systematic review of 11 observational studies involving 1718 patients suggests that non-dialytic conservative care (CC) may provide similar health-related quality of life (HRQoL) outcomes compared to dialysis for selected older patients with end-stage kidney disease (ESKD).

Patients who chose CC generally reported worse physical health outcomes and symptoms compared to those who had not yet started dialysis, but similar outcomes to those already on dialysis, indicating that CC could be a viable alternative for certain patients.

NCBI (Pubmed)

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. Verberne, WR., van den Wittenboer, ID., Voorend, CGN., et al.[2021]

In patients with end-stage kidney disease (ESKD), dialysis may not always be the best option, and comprehensive conservative care can be a viable alternative that focuses on improving quality of life rather than just survival.

Comprehensive conservative care involves managing symptoms and health issues like fluid balance, anemia, and dietary needs, and requires collaboration between nephrology and palliative care to effectively support patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Conservative Care in End-Stage Kidney Disease. Palat, G., Shenoy, SV., Shetty, L., et al.[2021]

Many patients with kidney failure are unaware that conservative care (CC) is a treatment option, highlighting the need for better education about treatment choices.

Patients generally feel supported by family in their decision-making for CC, but some report feeling pressured by healthcare professionals to choose dialysis; ultimately, most patients express satisfaction with their choice of CC, valuing quality of life over the burdens of dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choosing Conservative Care in Advanced Chronic Kidney Disease - Patients' Perspectives. Jongejan, M., de Lange, S., Bos, WJW., et al.[2023]

Comprehensive conservative care for stage 5 chronic kidney disease focuses on managing the condition without dialysis, particularly for elderly and frail patients, emphasizing quality of life and informed decision-making by patients and caregivers.

This approach requires a multidisciplinary team to effectively slow disease progression, prevent complications, and support patients and caregivers, while also addressing barriers to accessing this type of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive conservative care for the management of advanced chronic kidney disease Hamroun, A., Glowacki, F.[2023]

A program initiated in 2011 allowed 76 patients with advanced chronic kidney disease (ACKD) to receive home-based care from Primary Care Teams, significantly reducing the need for emergency department visits (51%) and hospitalizations (58%).

The program demonstrated that with proper support from Palliative Care and Nephrology, ACKD patients not eligible for dialysis could be effectively monitored at home, with 50% of patients dying at home, indicating a preference for home-based end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Palliative Care for Patients with Advanced Chronic Kidney Disease: Preliminary Results. Teruel, JL., Rexach, L., Burguera, V., et al.[2023]

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]

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]

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

Characterising patients and clinician experiences in comprehensive conservative care for kidney failure in Northern Queensland. [2023]

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]

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

Comprehensive Conservative Care in End-Stage Kidney Disease. [2021]

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

Choosing Conservative Care in Advanced Chronic Kidney Disease - Patients' Perspectives. [2023]

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

Comprehensive conservative care for the management of advanced chronic kidney disease [2023]

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

Home Palliative Care for Patients with Advanced Chronic Kidney Disease: Preliminary Results. [2023]