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Not yet recruiting NCT07322172

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

No phase Interventional Kidney Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient Navigation.
Who it may be relevant to
Registry conditions: Kidney Stones. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 institutiona

Primary outcome measures

  • 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 outcome measures (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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • UCSF — San Francisco

Publications

  • 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
  • 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

Identifiers

NCT: NCT07322172 · 25-45298 · 1K23DK141906-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗