CHOOSE Home Intervention for Dialysis

(CHOOSE Home Trial)

Overseen By Montserrat Chavez, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Active malignancy, Survival < 1 year, others

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

Compensation: Varies

Number of Visits: 6

106 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the CHOOSE Home Intervention treatment for dialysis?

Research shows that home dialysis, which is part of the CHOOSE Home Intervention, is linked to better clinical outcomes, greater patient convenience, and lower costs compared to in-center dialysis. Additionally, home dialysis has been associated with similar survival rates to traditional in-center dialysis, suggesting it is an effective alternative. ^{1 2 3 4 5}

Is the CHOOSE Home Intervention for Dialysis safe for humans?

Home hemodialysis (HD) has an excellent safety record, but there are risks of serious adverse events (unwanted effects) when patients perform HD at home without supervision. These risks include issues with vascular access (the way blood is accessed for dialysis), water quality, and procedural problems, but systematic safety measures can help manage and prevent these events. ^{6 7 8 9 10}

How does the CHOOSE Home Intervention treatment for dialysis differ from other treatments?

The CHOOSE Home Intervention treatment for dialysis is unique because it focuses on home-based dialysis, which allows patients to perform dialysis at home, offering more independence and flexibility compared to traditional in-center dialysis. This approach can improve quality of life by reducing the need for frequent trips to a dialysis center and allowing patients to integrate treatment into their daily lives more seamlessly. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this clinical trial is to learn if this intervention (the CHOOSE Home intervention) is feasible and may lead to more home dialysis usage in a high-risk patient population. The main questions it aims to answer are: * Will there be an increase in home dialysis selection or initiation over study follow up? * Will there be a change in patient reported status of Health-Related Social Needs (HRSNs) and patient engagement at 1 year follow up? Researchers will compare the intervention group that will include interdisciplinary care (IDC) and the integration of a Community Health Worker (CHW) into the chronic kidney disease (CKD) care process to the IDC only control group. The research team will assess whether the intervention led to better social care navigation, enhanced patient engagement, and increased home dialysis use.

Research Team

Tanya S Johns, MD, MHS

Principal Investigator

Albert Einstein College of Medicine

Eligibility Criteria

This trial is for patients with chronic kidney disease (CKD) who are considering dialysis options. It's designed to see if adding a Community Health Worker to their care team helps them navigate social care, engage more in their health, and choose home dialysis.

Inclusion Criteria

Provide informed consent

Has at least one unmet social need amenable to CHW intervention

My kidney function is very low.

Exclusion Criteria

Anticipated survival is less than 1 year as determined by the patient's treating nephrologist

Plan to relocate outside of New York City within the next 12 months

I currently have cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive community health worker facilitated social care navigation and peer support as part of interdisciplinary care for CKD

1 year

Visits at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for changes in home dialysis selection, health-related social needs, and patient engagement

1 year

Treatment Details

Interventions

• CHOOSE Home Intervention

Trial Overview The study compares two groups: one receives usual interdisciplinary care (IDC), while the other gets IDC plus the CHOOSE Home intervention involving a Community Health Worker. The focus is on increasing home dialysis use and improving patient engagement.

Participant Groups

Group I: IDC alone Experimental Treatment 1 Intervention

Patients will receive IDC (Interdisciplinary Care) only. They will not receive CHW (Community Health Worker) facilitated peer support and social care navigation. Participants will complete surveys, questionnaires, or interviews at baseline, 6 months, and 12 months.

Group II: CHW facilitated social care navigation and peer support as part of IDC Experimental Treatment 1 Intervention

Patients will receive community health worker (CHW) facilitated social care navigation and peer support around kidney replacement therapy (KRT) decision-making as part of their interdisciplinary care (IDC) for CKD, up to 1 year. Participants will complete surveys, questionnaires, or interviews at baseline, 6 months, and 12 months.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

In a review of home hemodialysis (HD) programs involving 190 patients over approximately 500 patient-years, there was a low incidence of life-threatening adverse events, with a rate of 0.060 events per 1,000 dialysis treatments.

Most adverse events were linked to human error and protocol lapses, highlighting the importance of thorough patient training and safety monitoring to enhance the safety of home HD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedure-related serious adverse events among home hemodialysis patients: a quality assurance perspective. Wong, B., Zimmerman, D., Reintjes, F., et al.[2014]

The Home Dialysis Virtual Ward (HDVW) trial, involving 193 patients, effectively identified potential care gaps, particularly for those recently discharged from the hospital, indicating a need for enhanced support during transitional states.

Patient satisfaction with the HDVW was high, with a median rating of 8 out of 10, suggesting that this intervention positively impacted their overall health, understanding of treatment, and access to nephrology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Care Gaps in Home Dialysis: The Home Dialysis Virtual Ward Study. Nadeau-Fredette, AC., Chan, CT., Bargman, JM., et al.[2020]

References

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

A breakthrough series collaborative to increase patient participation with hemodialysis tasks: A stepped wedge cluster randomised controlled trial. [2021]

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

Survival Comparisons of Home Dialysis Versus In-Center Hemodialysis: A Narrative Review. [2022]

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

The resurgence of home dialysis therapies. [2007]

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

From Home Dialysis Access to Home Dialysis Quality. [2022]

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

Development of an instrument to assess self-management capacity of patients receiving peritoneal dialysis: CAPABLE. [2022]

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

Quality Assurance and Preventing Serious Adverse Events in the Home Hemodialysis Setting. [2021]

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

Procedure-related serious adverse events among home hemodialysis patients: a quality assurance perspective. [2014]

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

Adverse technical events in home hemodialysis. [2014]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Predictors of Care Gaps in Home Dialysis: The Home Dialysis Virtual Ward Study. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

Patient safety in home hemodialysis: quality assurance and serious adverse events in the home setting. [2015]

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

Contrasting Perceptions of Home Dialysis Therapies Among In-Center and Home Dialysis Staff. [2016]

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

Home hemodialysis--yes, it can be learned. [2019]

13. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Benefits and implementation of home hemodialysis: A narrative review. [2018]

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

Whatever happened to home hemodialysis? [2019]

15. Japan pubmed.ncbi.nlm.nih.gov

[A study of factors to be considered whether a patient to have a home dialysis service or not]. [2010]