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Completed

NCT Number: NCT06835439

Development of STEPPT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Health Centers of San Diego

San Diego, California, 92102, United States

About this study

STEPPT is a health system, quality improvement intervention for Hispanic patients with spine pain including the following components: (1) education of providers and staff on disparities in referrals and the benefits of physical therapy for spine pain, (2) modifications to the EHR to automate physical therapy referral and delivery of culturally tailored patient education materials, and (3) enhanced patient health navigation to educate patients and address barriers to attending physical therapy for Hispanic patients with spine pain. This pilot study aims to test the feasibility and acceptability of a prototype intervention developed using patient feedback, focus groups, and collaboration with Family Health Centers of San Diego (FHCSD) administrators and staff. The primary outcome is change in relative rates of referral and adherence to physical therapy between Hispanic and Non-Hispanic White patients with spine pain before and after implementation of the STEPPT intervention within one pilot clinic in the health system. The study will collect data on physical therapy referrals and adherence from electronic health records (EHR) before (3-month usual care control phase) and after (3-month intervention phase) implementing STEPPT. A process evaluation will be conducted through monthly audits and structured observations of clinic workflow. Ongoing interactions with clinic staff will facilitate implementation of the intervention and solicit suggestions for improving feasibility. Post-intervention interviews with a subset of Hispanic patients will assess acceptability of the intervention. Interviews will focus on patient experiences with education materials and enhanced healthcare navigation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STEPPT Pilot

Behavioral

The pilot STEPPT intervention, which includes (1) education of providers and staff on disparities in referrals and the benefits of physical therapy for spine pain, (2) modifications to the EHR to automate physical therapy referral and delivery of culturally tailored patient education materials related to the physical therapy referral, and (3) enhanced patient health navigation to educate patients on physical therapy and address barriers to attending physical therapy for Hispanic patients with spine pain. Patient education materials were developed using evidence-based guidelines and were culturally and linguistically adapted for Hispanic patients with spine pain.

Standard care (control)

Behavioral

Usual care (3-month baseline) includes no provider education, physician-initiated referrals and delivery of standard educational materials, and scheduling for physical therapy by the clinic referrals specialists using standard processes.

Primary outcomes

  1. Ethnic Disparity in Rate of Physician Referral to Physical Therapy

    Time frame: 3-month before the intervention and 3 month during intervention period.

    Ethnic disparity (Hispanic vs. Non-Hispanic White) in rate of physician referral of patients with spine pain (low back or neck pain) to physical therapy, as documented in the electronic health record (EHR).

  2. Ethnic Disparity in Rate of Patient Adherence to Physical Therapy Referral

    Time frame: 3-month before the intervention and 3 month during intervention period.

    Ethnic disparity (Hispanic vs. Non-Hispanic White) in rate of attendance of first physical therapy visit after being referred, as documented in the electronic health record (EHR).

Secondary outcomes

  1. Involvement Rating Score

    Time frame: 3-month pilot intervention period.

    This outcome is a clinic-level composite implementation score assessed once for a single clinic. Because only one clinic was evaluated, a measure of dispersion cannot be calculated, and the reported value reflects the single observed score. The total score ranges from 0 to 11 points and is categorized as unsatisfactory (0-3), moderate (4-7), and satisfactory (8-11) involvement of FHCSD providers and staff in STEPPT training. The score is composed of five components: Provider Orientation (0-3), Audit and Feedback (0-2), Enhanced Care Navigation Outreach (0-2), Enhanced Care Navigation Delivery (0-2), and Video Views (0-2).

  2. Patient Interviews

    Time frame: Up to 3-months post-intervention

    Qualitative interviews to assess acceptability and potential impact of the STEPPT intervention on Hispanic patients with spine pain.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • Family Health Centers of San Diego
  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Improving Access and Engagement in Spine Pain Rehabilitation - STEPPT Mixed Methods Pilot Study

Acronym: STEPPT PILOT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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