About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years
Unable to provide informed consent
Non-English-speaking
No outpatient urology referral placed from the Emergency Department
Trial design
Single group
Treatments tested in this trial
Patient Navigation
Other interventionThe 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.
Treatment groups
Trial 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.
Secondary outcomes
Acceptability of the Patient Navigation Intervention Measured by the Patient Navigation Process and Outcomes Measure (PNPOM)
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: