ClinicalTrials.gg
Not yet recruitingNCT07322172Updated Sep 15, 2026

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

An interventional study of Patient Navigation in Kidney Stones, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 193 studies in Kidney Calculi with a site in United States — 42 open to participants now, 58 under way, none of them phase 3. Kidney Calculi · United States.

Planned enrollment
99th of 165
31 · median 47
Started
2026
with 13 others
No phase
113 of 193
29 open now
Primary completion
2027-07
later than 34 of 57 live
Registered
184th of 193
by date
Lead sponsor
6 of 193
University of California, San Francisco

Among the 193 studies in Kidney Calculi with a site in United States, this one is the 99th largest by planned enrollment of the 165 interventional ones, is one of 14 that started in 2026, is one of 113 with no phase, reaches primary completion later than 34 of the 57 other live ones, and was the 184th registered.

By phase

193 studies; the count open now beside each. This study's row is marked.

No phasethis study113 · 29 open
Observational28 · 5 open
Phase 216 · 1 open
Phase 413 · 1 open
Phase 18 · 5 open
Phase 38 · 0 open
Phase 1/26 · 1 open
Phase 2/31 · 0 open

By the year they started

First in 1998; this study’s year is marked. 14 started in 2026.

Size and results

Median enrollment 47 across the 165 interventional studies, 122 across the 28 observational. Of the 116 that completed or were terminated, 51 (44%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 193 studies in Kidney Calculi with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Kidney Stones

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age \< 18 years
  • Unable to provide
  • Non-English-speaking
  • No outpatient urology referral placed from the Emergency Department
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (estimated)

Study arms

  • Experimental
    Patient Navigation Intervention

    Other: Patient Navigation

Interventions

  • OtherPatient 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.

06

What researchers measure

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)

    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.

    Time frame: From enrollment to the end of treatment at 12 weeks

07

Study locations

1 site
08

References and documents

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. PubMed 41405624 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jul 2027, 7 months later.

Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 7 months is below that.

Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2026
First posted
Jan 7, 2026
StartEst.
Dec 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07322172
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

David Bayne, MD
Contact
david.bayne@ucsf.edu
617-571-5870
David Bayne, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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