Development of STEPPT (NCT06835439) | Clinical Trial Compass
CompletedNot Applicable
Development of STEPPT
United States144 participantsStarted 2024-11-02
Plain-language summary
This 6-month pilot study aims to assess the feasibility, acceptability, and estimate effect sizes of the pilot STEPPT intervention for addressing ethnic disparities in physical therapy referrals and adherence between Hispanic and Non-Hispanic White patients with spine pain. Feasibility and acceptability will be assessed based on the extent to which the pilot clinic implements all components of the intervention appropriately, feedback from clinic staff during implementation of the intervention, and feedback from patients during post-intervention interviews. The investigators anticipate that the intervention will be both feasible and acceptable. Feedback from patients and clinic staff will be used to inform intervention modifications for a larger clinical trial. Effect sizes for the pilot STEPPT intervention (intervention) in comparison to standard care (control) will be assessed by evaluating changes in ethnic disparities (Hispanic vs. Non-Hispanic White) in physician referral to physical therapy and patient adherence to physical therapy referral for the treatment of spine pain before and after implementation of the pilot STEPPT intervention. In comparison to standard care, the investigators expect STEPPT to reduce ethnic disparities in referral and adherence outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18 years or older.
* Patients seeking care within the designated Federally Qualified Health System Adult or Adult Walk-in primary care clinic
* Ethnicity/Race: Participants must identify as either Hispanic or Non-Hispanic White ethnicity/race.
* Consent: Participants must have signed a broad consent for the use of de-identified health information for research.
* Spine Pain: Participants must meet one of the following:
* New Spine Pain Problem: A new ICD code for neck or back pain added to the problem list during a visit with a primary care physician.
* Existing Spine Pain Diagnosis: 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.
Exclusion Criteria:
* Non-Musculoskeletal Spine Pain: Participants with spine pain due to a non-musculoskeletal etiology (e.g., infection, cancer, urological disorders, pregnancy) are excluded.
* Urgent Medical Conditions: Patients requiring urgent medical intervention (e.g., fracture, cauda equina syndrome) are excluded.
* Patients with a physical therapy referral external to the healthcare system are excluded from the analysis of physical therapy adherence
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ethnic Disparity in Rate of Physician Referral to Physical Therapy
Timeframe: 3-month before the intervention and 3 month during intervention period.
2
Ethnic Disparity in Rate of Patient Adherence to Physical Therapy Referral
Timeframe: 3-month before the intervention and 3 month during intervention period.