Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07322172

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Bayne, MD

CONTACT

[email protected]

617-571-5870

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.