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Clinical Trials/NCT07322172
NCT07322172
Not yet recruiting
Not Applicable

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

University of California, San Francisco1 site in 1 country31 target enrollmentStarted: January 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
31
Locations
1
Primary Endpoint
Completion of an outpatient urology follow-up visit within 12 weeks of emergency department discharge, assessed through review of the electronic health record.

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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