30 Participants Needed

Home-Based Care for Advanced Kidney Disease

SW
RR
Overseen ByRachel R Smith
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12346

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.13478

Research Team

SW

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.
See 3 more

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
See 3 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: CC Program Received InterventionExperimental Treatment1 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 CareActive Control1 Intervention
Does not receive intervention.

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

πŸ‡ͺπŸ‡Ί
Approved in European Union as Conservative Care for:
  • Advanced Chronic Kidney Disease (CKD)
  • End-Stage Renal Disease (ESRD)
πŸ‡ΊπŸ‡Έ
Approved in United States as Conservative Care for:
  • Advanced Chronic Kidney Disease (CKD)
  • End-Stage Renal Disease (ESRD)
πŸ‡¨πŸ‡¦
Approved in Canada as Conservative Care for:
  • Advanced Chronic Kidney Disease (CKD)
  • End-Stage Renal Disease (ESRD)

Find a Clinic Near You

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

References

Survival of patients who opt for dialysis versus conservative care: a systematic review and meta-analysis. [2022]
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]
Characterising patients and clinician experiences in comprehensive conservative care for kidney failure in Northern Queensland. [2023]
Health-related quality of life and symptoms of conservative care versus dialysis in patients with end-stage kidney disease: a systematic review. [2021]
Comprehensive Conservative Care in End-Stage Kidney Disease. [2021]
Choosing Conservative Care in Advanced Chronic Kidney Disease - Patients' Perspectives. [2023]
Comprehensive conservative care for the management of advanced chronic kidney disease [2023]
Home Palliative Care for Patients with Advanced Chronic Kidney Disease: Preliminary Results. [2023]
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