NCT07290361 Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)
| NCT ID | NCT07290361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | San Diego State University |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 17,587 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 17,587 participants in total. It began in 2025-12-01 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if a health system intervention called "Stratified Targeted Engagement from Primary Care to Physical Therapy (STEPPT)" can improve how often doctors refer Hispanic patients with spine pain to physical therapy (referral rate) and how often patients attend physical therapy after being referred (adherence rate). The main questions this study aims to answer are 1) does STEPPT improve physical therapy referral and adherence rates compared to usual care for Hispanic patients with spine pain who seek care in a Federally Qualified Health Center (FQHC) serving low income communities, and 2) how consistently do FQHC providers and staff deliver STEPPT to patients who may benefit? STEPPT will train doctors and other health care providers to educate participants on the benefits of physical therapy for spine pain and participants will receive culturally tailored handouts and videos to teach them about their spine pain and what to expect in physical therapy. Patients will also receive personalized assistance to schedule their physical therapy appointment and address potential barriers for attending the appointment.
Eligibility Criteria
Inclusion Criteria * 18 years or older. * Identify as either Hispanic or Non-Hispanic ethnicity, inclusive of all races. * Seeking care for spine pain at an Adult or Adult Walk-in primary care clinic within the participating Federally Qualified Health Center (FQHC). * New or existing spine pain problem: A new spine pain problem is defined by a new ICD code for neck or back pain added to the problem list during a visit with a primary care physician. An existing spine pain problem is defined by an existing ICD code for neck or back pain on the problem list that is associated with a physician referral for any service during the visit related to the neck or back pain problem. * Signed a broad consent for the use of de-identified health information for research at the participating FQHC. Exclusion Criteria: * Spine pain associated with a non-musculoskeletal etiology (e.g., infection, cancer, urological disorders, pregnancy, etc.) * Patients requiring urgent medical intervention (e.g., fracture, cauda equina syndrome, etc) * Active physical therapy referral for spine pain at the time of the index encounter. * Previously referred to physical therapy through the STEPPT Care Pathway. * Physical therapy referrals external to the FQHC will be excluded from the analysis of physical therapy adherence
Contact & Investigator
Katrina Monroe, PT, PhD
PRINCIPAL INVESTIGATOR
San Diego State University
Frequently Asked Questions
Who can join the NCT07290361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07290361 currently recruiting?
Yes, NCT07290361 is actively recruiting participants. Contact the research team at creal2@sdsu.edu for enrollment information.
Where is the NCT07290361 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT07290361 clinical trial?
NCT07290361 is sponsored by San Diego State University. The principal investigator is Katrina Monroe, PT, PhD at San Diego State University. The trial plans to enroll 17,587 participants.