~244 spots leftby Nov 2027

Community Health Interventions for Renal Disease

(INSPIRE Trial)

Recruiting in Palo Alto (17 mi)
+2 other locations
LC
Overseen byLili Chan
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a cluster randomized controlled clinical trial evaluating the effect of community health workers (CHWs) and provider education on kidney transplant (KTx) waitlisting compared to usual care (waitlist control). CKD/HD providers will be randomized to intervention or control, and all patients with the same providers will be in the same randomization group. CHWs will address unmet social needs and patient symptoms through evaluations and linkage to clinical and community services. Intervention providers will receive education, which will include training on working with CHWs, reducing bias in clinical decision-making, and increasing affirming/reducing stigmatizing language in electronic health records (EHRs).

Research Team

LC

Lili Chan

Principal Investigator

Ichan School of Medicine at Mount Sinai Hospital

Eligibility Criteria

This trial is for patients with renal disease who are under the care of CKD/HD providers. Participants will be grouped based on their provider's random assignment to either the intervention or control group. The study aims to help those facing social challenges that affect their health.

Inclusion Criteria

I speak English or Spanish.
Patient must receive kidney care at Mount Sinai, Einstein, Bellevue Hospital, NYU, or hemodialysis at a participating HD Center
Patient must be community dwelling (not in a nursing home or currently incarcerated)
See 6 more

Exclusion Criteria

Provider must be planning to leave their respective institutions in the next 1 year
Patient must have been previously evaluated by KTx and not listed for specific medical reasons
Patient must already be listed for KTx
See 4 more

Treatment Details

Interventions

  • Community Health Worker Assistance (Behavioural Intervention)
  • Intervention Providers (Behavioural Intervention)
Trial OverviewThe trial is testing if support from community health workers and additional education for kidney transplant providers can increase the number of patients getting on a transplant waitlist, compared to usual care without this extra support.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment3 Interventions
Participants will receive usual care and at the end of the study will receive education, and work with CHWs in a more limited capacity. Control clinicians will receive the education intervention.
Group II: Community Health Worker and Intervention Providers-Assisted Kidney Transplant SupportExperimental Treatment2 Interventions
Participants will receive assignment to a community health worker who will educate them on the kidney transplant process, assist them through the kidney transplant process and connect them with any necessary social services.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+
Dr. Brendan Carr profile image

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin profile image

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

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

Collaborator

Trials
2,513
Recruited
4,366,000+
Dr. Griffin P. Rodgers profile image

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers profile image

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.