Pilot Study of Patient Navigation for Kidney Stone Patients After ED Visits

NCT ID: NCT07322172

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-07-31

Brief Summary

Patients who visit the emergency department for kidney stones are sometimes referred to urology for follow-up care but never complete that visit. Missing follow-up appointments can lead to worse outcomes, including recurrent pain, infection, or surgery. Research shows that patients who are socially or economically at risk (such as those with public insurance, lower income, or limited English proficiency) are more likely to experience these care gaps.

This study will pilot a patient navigation program designed to help patients with urinary stone disease (USD) attend their scheduled urology appointments after being seen in the Emergency Department. Using an electronic health record (EHR) based prediction model developed in earlier research, patients at higher risk for being lost to follow-up will be identified and invited to participate. Each participant will be paired with a trained patient navigator who will assess barriers to care, provide support, and maintain contact for about 12 weeks.

The goal of this study is to evaluate the outcomes and feasibility of this navigation intervention. Findings will help determine whether a larger study should test if this approach improves access to care and health outcomes for patients with kidney stones.

Conditions

Kidney Stones

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient Navigation Intervention

Group Type: EXPERIMENTAL

Patient Navigation

Intervention Type: OTHER

The intervention consists of a patient navigation program delivered by a patient navigator over approximately 12 weeks. Participants identified as high risk for loss to follow-up after an emergency department visit for kidney stone disease will receive individualized navigation support focused on identifying and addressing barriers to urology follow-up. Navigation activities may include care coordination support, appointment scheduling guidance, health education, linkage to existing institutional or community resources (transportation assistance or insurance enrollment support), and motivational support. The patient navigator will maintain regular contact with participants through in-person, phone, or virtual encounters, and navigation activities will be documented in a secure research database. The intervention is designed to support access to recommended care and does not alter clinical treatment decisions.

Interventions

Patient Navigation

The intervention consists of a patient navigation program delivered by a patient navigator over approximately 12 weeks. Participants identified as high risk for loss to follow-up after an emergency department visit for kidney stone disease will receive individualized navigation support focused on identifying and addressing barriers to urology follow-up. Navigation activities may include care coordination support, appointment scheduling guidance, health education, linkage to existing institutional or community resources (transportation assistance or insurance enrollment support), and motivational support. The patient navigator will maintain regular contact with participants through in-person, phone, or virtual encounters, and navigation activities will be documented in a secure research database. The intervention is designed to support access to recommended care and does not alter clinical treatment decisions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Presentation to the Emergency Department with urinary stone disease
• Placement of an outpatient urology referral from the Emergency Department
• Identified as high risk for loss to follow-up based on the study's screening process

Exclusion Criteria

• Age < 18 years
• Unable to provide informed consent
• Non-English-speaking
• No outpatient urology referral placed from the Emergency Department

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Bayne, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF

San Francisco, California, United States

Countries

United States

Central Contacts

David Bayne, MD

Role: CONTACT

david.bayne@ucsf.edu

617-571-5870

Facility Contacts

David Bayne, MD

Role: primary

david.bayne@ucsf.edu

617-571-5870

Amanda Fragoso

Role: backup

amanda.fragoso@ucsf.edu

References

Srirangapatanam S, Suarez P, Chi T, Neuhaus J, Stoller M, Scales S, Bayne D. EMR data enhances prediction accuracy for care delays compared to standard demographic data. Presented at: AUA 2024, San Antonio, Texas, May 3-6. Abstract MP40-08

Reference Type: BACKGROUND

Suarez PA, Srirangapatanam S, Leng L, Momodu MM, Neuhaus J, Bayne DB. Enhancing surgical efficiency: predicting same-day cancellations in urologic procedures. World J Urol. 2025 Dec 17;44(1):48. doi: 10.1007/s00345-025-06155-6.

Reference Type: BACKGROUND

PMID: 41405624 (View on PubMed)

Other Identifiers

1K23DK141906-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-45298

Identifier Type: -

Identifier Source: org_study_id