CHOOSE Home Intervention for Dialysis

(CHOOSE Home Trial)

Recruiting at 1 trial location

Overseen By Yaxkyn A Mejia, BS

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the CHOOSE Home Intervention can help more individuals with advanced chronic kidney disease (CKD) start or choose home dialysis. Researchers seek to assess whether adding a Community Health Worker (CHW) to the care team enhances social support and increases patient involvement. Participants will either receive additional assistance from a CHW or continue with their regular interdisciplinary care (IDC) for comparison. Those with advanced CKD who speak English or Spanish, visit a nephrologist regularly, and have unmet social needs may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies for CKD patients.

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 prior data suggests that the CHOOSE Home intervention is safe?

Research has shown that programs involving community health workers (CHWs), such as the CHOOSE Home program, are generally well-received. These programs have successfully helped people manage their health and reduced disparities in health outcomes among different groups. They have proven safe and effective in various situations. No specific evidence indicates serious side effects from using CHWs in this type of program. As this is not a new drug or medical treatment but a support method, the risks are considered low. The focus remains on improving care and support, not adding medical risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHOOSE Home Intervention for dialysis patients because it introduces community health worker (CHW) facilitated social care navigation and peer support into the interdisciplinary care (IDC) process for chronic kidney disease (CKD). Unlike traditional kidney replacement therapy (KRT) approaches that typically focus solely on the medical aspects, this intervention integrates social support and decision-making guidance, potentially improving patient engagement and outcomes. By addressing social determinants of health and providing personalized support, the trial aims to enhance patients' overall experience and effectiveness of their treatment pathway.

What evidence suggests that the CHOOSE Home intervention is effective for increasing home dialysis usage?

Research has shown that involving a Community Health Worker (CHW) in patient care can lead to better health outcomes. Studies have found that CHWs empower patients to manage their health and can reduce disparities in health outcomes among different groups. In this trial, the CHOOSE Home program, which includes CHW-facilitated social care navigation and peer support, aims to achieve similar results for people with chronic kidney disease (CKD) by guiding them in their care and helping them make informed choices about home dialysis. Early results suggest that this approach may encourage more patients to choose home dialysis, which can be more convenient and comfortable. By addressing social needs and engaging patients more effectively, the program aims to increase the use of home dialysis. Another arm of this trial will provide Interdisciplinary Care (IDC) alone, without additional CHW support, to compare outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Tanya S Johns, MD, MHS

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

New York University

Collaborator

Trials

249

Recruited

229,000+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/choose-home-intervention-for-dialysis-3dc3f

CHOOSE Home Intervention for Dialysis 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06925776

Study Details | NCT06925776 | Community Health Workers ... The investigator team hypothesizes that the CHOOSE Home intervention may lead to increased home dialysis utilization by more effectively addressing health- ...

3. reporter.nih.gov reporter.nih.gov/project-details/10972945

the CHOOSE Home trial - NIH RePORTER We hypothesize that the CHOOSE Home intervention is feasible and may lead to increased home dialysis utilization by more effectively addressing health-related ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925006540

Adaptation of Navigate-Kidney: A Community Health ... Community health worker (CHW) interventions have been effective in reducing health disparities and promoting self-management; however, they have ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2841228

Participant Experiences in a Kidney Failure Care Intervention Effect of community health worker support on clinical outcomes of low-income patients across primary care facilities: a randomized clinical ...

6. trialx.com trialx.com/clinical-trials/listings/325492/community-health-workers-in-an-interdisciplinary-outpatient-ckd-clinic-to-optimize-social-care-navigation-patient-engagement-and-home-dialysis-utilization/?&radius=10&place=Seoul,%20etc.&user_country=Korea,%20Republic%20of

Community Health Workers in an Interdisciplinary ... 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 ...