Patient Navigation for Kidney Stones

Overseen By David Bayne, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Under 18, Non-English-speaking, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with kidney stones adhere to follow-up care after emergency room visits. The study uses patient navigators, trained to guide and support patients in making and attending urology appointments. The aim is to determine if this support can improve health outcomes by reducing the risk of pain, infection, or surgery from missed appointments. It suits individuals who visited the emergency room for kidney stones, were referred to a urologist, and may face challenges like low income or language barriers that hinder follow-up care. As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions that could benefit many patients in the future.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on helping you attend follow-up appointments rather than changing your medication.

What prior data suggests that this patient navigation program is safe for patients with kidney stones?

Research has shown that patient navigation programs can help individuals with kidney stones receive necessary follow-up care. Studies reveal that nearly 40% of those with kidney stones do not receive follow-up care after visiting the emergency room. Without this care, they may face more kidney stones or other health problems.

Patient navigation pairs patients with a trained guide who assists with tasks like scheduling appointments and understanding medical advice. As a supportive program rather than a medical treatment, patient navigation poses no specific safety concerns. It is low-risk and generally well-received. The program aims to help patients attend their appointments, potentially preventing future health issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Navigation treatment for kidney stones because it offers a personalized approach to managing the condition. Unlike traditional treatments, which typically involve medications, shock wave therapy, or surgery, Patient Navigation focuses on guiding patients through the healthcare system to improve their outcomes. This approach aims to enhance patient education, adherence to treatment plans, and timely follow-ups, potentially reducing the recurrence of kidney stones and improving overall patient well-being.

What evidence suggests that this patient navigation program is effective for improving follow-up care for kidney stones?

Research has shown that a patient navigator can improve follow-up care for people with kidney stones. Studies found that nearly 40% of individuals with kidney stones don't see a doctor after an emergency room visit, and about 80% never consult a specialist. Lack of follow-up can lead to more pain, infections, or even surgery. In this trial, participants will receive the Patient Navigation Intervention, where a patient navigator guides them in tasks like making appointments or finding transportation to doctor visits. This approach aims to ensure patients attend their follow-up appointments, potentially improving their health. Early results suggest that this method could effectively manage care for people with kidney stones. ^{1 2 3 4 6}

Who Is on the Research Team?

David Bayne, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 who went to the ER for kidney stones and are at high risk of missing their follow-up urology appointments. It's especially aimed at helping those with social or economic challenges.

Inclusion Criteria

Identified as high risk for loss to follow-up based on the study's screening process

I am 18 years old or older.

I went to the ER for kidney stones.

Exclusion Criteria

Non-English-speaking

No outpatient urology referral placed from the Emergency Department

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Patient Navigation Intervention

Participants are paired with a trained patient navigator who assesses barriers to care, provides support, and maintains contact

12 weeks

Follow-up

Participants are monitored for outcomes and feasibility of the navigation intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation

Trial Overview

The study tests a patient navigation program where participants get personalized help from a navigator to overcome barriers and make it to their urology appointments after an ER visit.

How Is the Trial Designed?

Group I: Patient Navigation Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07322172

Pilot Study of Patient Navigation for Kidney Stone ...

The goal of this study is to evaluate the outcomes and feasibility of this navigation intervention. Findings will help determine whether a ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S009042952500634X

Care Navigation in the Management of Urinary Stone ...

Nearly 40% of individuals with kidney stones presenting for care to the emergency department (ED) do not receive any physician follow-up and almost 80% never ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40581223/

Care Navigation in the Management of Urinary Stone ...

Nearly 40% of individuals with kidney stones presenting for care to the emergency department (ED) do not receive any physician follow-up and ...

4.

auajournals.org

auajournals.org/doi/10.1097/JU.0000000000004242

A Patient-Prioritized Research Agenda for Clinical Trials in ...

Patients and caregivers valued comparative effectiveness kidney stone research that focused on individualized care, shared decision-making, and ...

5.

news.vumc.org

news.vumc.org/2023/08/08/vise-team-works-to-develop-3d-navigation-system-to-better-treat-kidney-stones/

VISE team works to develop 3D navigation system ...

A multidisciplinary team at Vanderbilt is working to create a real-time navigational system to decrease residual stone fragments left behind after kidney stone ...

6.

withpower.com

withpower.com/trial/phase-kidney-calculi-2026-7401b

Patient Navigation for Kidney Stones · Info for Participants

Missing follow-up appointments can lead to worse outcomes, including recurrent pain, infection, or surgery. Research shows that patients who are ...