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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new home-based care program for individuals with advanced chronic kidney disease (CKD) who have opted not to begin regular dialysis treatments. The study aims to determine if the CC Program (Comprehensive Conservative Care), which provides personalized care from a team of medical professionals, is both feasible and well-received by patients and their caregivers. The program focuses on delivering comprehensive care and planning for future health needs. Suitable participants have advanced CKD, receive care from the VA Puget Sound Health Care System, and have chosen not to start dialysis. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions for CKD without requiring dialysis.

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 prior data suggests that the CC Program is safe for patients with advanced chronic kidney disease?

Research has shown that comprehensive conservative care (CC) for advanced kidney disease is generally well-tolerated by patients. This approach can slow disease progression and manage symptoms effectively.

For patients with advanced chronic kidney disease (CKD) who choose not to start dialysis, CC aims to improve quality of life. A team of healthcare providers, including doctors, nurses, and social workers, collaborates to offer personalized care, manage symptoms, and support decision-making.

Reports of negative side effects are limited, indicating general safety. However, as with any treatment, individual experiences may vary, so discussing personal health concerns with the healthcare team involved in the trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CC Program is unique because it offers a comprehensive, home-based approach to managing advanced kidney disease, unlike traditional treatments that often require frequent clinic visits or hospital stays. This program integrates a team of healthcare professionals, including doctors, nurses, pharmacists, and social workers, providing patient-centered and whole-person care right in the comfort of the patient's home. Researchers are excited about this method because it emphasizes shared decision-making and personalized care, which can significantly improve quality of life and potentially reduce the need for emergency interventions.

What evidence suggests that the CC Program might be an effective treatment for advanced CKD?

Research shows that conservative care (CC), which participants in this trial may receive, can be a good alternative to dialysis for people with advanced chronic kidney disease (CKD). Studies have found that CC aims to slow the progression of kidney disease and reduce complications. This care includes managing symptoms, assisting with decision-making, and planning for end-of-life care. Healthcare professionals consider kidney supportive care crucial for treating kidney failure, as it offers a comprehensive and patient-focused approach. Some studies suggest that for older patients, CC might even surpass dialysis in providing a more balanced quality of life. ^{1 4 6 7 8}

Who Is on the Research Team?

Ann M. O'Hare, MD MA

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5053791/

Comprehensive Conservative Care in End-Stage Kidney ... We provide a clear definition of comprehensive conservative care. This includes interventions to delay progression of kidney disease and minimize complications.

2. kidney-international.org kidney-international.org/article/S0085-2538(23)00683-X/fulltext

core components of integrated care for people with ... Conservative kidney management and kidney supportive care: core components of integrated care for people with kidney failure

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12255982/

Kidney supportive care in advanced chronic kidney disease This study systematically reviews and synthesizes healthcare professionals' perspectives on Kidney Supportive Care (KSC) to establish an ...

4. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-018-1004-4

Value-based evaluation of dialysis versus conservative care in ... Conservative care is argued to be a reasonable treatment alternative for dialysis in older patients with advanced chronic kidney disease (CKD).

5. ajkd.org ajkd.org/article/S0272-6386(20)31007-6/fulltext

A Qualitative Study of US Patients and Family Members Qualitative study using cognitive interviewing about attitudes regarding conservative care using decision aids on treatments for advanced kidney disease.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27510453/

Comprehensive Conservative Care in End-Stage Kidney ... We provide a clear definition of comprehensive conservative care. This includes interventions to delay progression of kidney disease and minimize complications.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2790050

Conservative Care for Kidney Failure—The Other Side of ... Outcomes Among Patients With Advanced Kidney Disease Who Forgo Maintenance Dialysis ... Population-level data on conservative kidney care ...

8. jrnjournal.org jrnjournal.org/article/S1051-2276(23)00022-5/fulltext

Caring for Patients With Advanced Chronic Kidney Disease Caring for patients with advanced chronic kidney disease: dietary options and conservative care instead of maintenance dialysis.