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

NCT07322172 | Not Yet Recruiting

• 2 other identifiers: 25-452981K23DK141906-01A1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Completion of an outpatient urology follow-up visit within 12 weeks of emergency department discharge, assessed through review of the electronic health record.

  From enrollment to the end of intervention at 12 weeks

Secondary Outcomes (1)

• Acceptability of the Patient Navigation Intervention Measured by the Patient Navigation Process and Outcomes Measure (PNPOM)

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

Patient Navigation Intervention

EXPERIMENTAL

Other: Patient Navigation

Interventions

Patient Navigation 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.

Patient Navigation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCSF

San Francisco, California, 94110, United States

Location

Related Publications (2)

• 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

  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.

  PMID: 41405624 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• David Bayne, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Bayne, MD

CONTACT

617-571-5870; david.bayne@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 7, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)