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

April 6, 2026 updated by: University of California, San Francisco

Pilot Study of Patient Navigation Intervention to Improve Follow-up Care for Patients With Urinary Stone Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Navigation Intervention
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion of an outpatient urology follow-up visit within 12 weeks of emergency department discharge, assessed through review of the electronic health record.
Time Frame: From enrollment to the end of intervention at 12 weeks
From enrollment to the end of intervention at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the Patient Navigation Intervention Measured by the Patient Navigation Process and Outcomes Measure (PNPOM)
Time Frame: From enrollment to the end of treatment at 12 weeks
Acceptability will be assessed using the Patient Navigation Process and Outcomes Measure (PNPOM), a validated questionnaire administered to patient participants at the completion of the intervention. The PNPOM evaluates participants' perceptions of the navigation experience, including satisfaction, perceived usefulness, and support received. Responses are scored on a Likert-type scale, with higher scores indicating greater acceptability of the navigation intervention. The total score will be summarized descriptively to assess overall intervention acceptability.
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

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

Investigators

  • Principal Investigator: David Bayne, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-45298
  • 1K23DK141906-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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