Clinical trial NCT06835439: Development of STEPPT
Official title: Improving Access and Engagement in Spine Pain Rehabilitation - STEPPT Mixed Methods Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain
Back Pain
Low Back Pain
Chronic Pain
Neck Pain
Keywords: Physical therapy
Rehabilitation
Hispanic
Health disparities
Health services
Healthcare utilization
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Family Health Centers of San Diego
First posted: 2025-02-19
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The primary purpose of this pilot study is to assess the feasibility, acceptability, and estimate effect size of the pilot STEPPT intervention for improving ethnic disparities in physical therapy referral and adherence between Hispanic and Non-Hispanic White patients with spine pain. The health services intervention design is a single site, mixed-methods pilot study using a non-randomized quasi-experimental pre-post design.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Ethnic Disparity in Rate of Physician Referral to Physical Therapy
timeFrame: 3-month before the intervention and 3 month during intervention period.
measure: Ethnic Disparity in Rate of Patient Adherence to Physical Therapy Referral
timeFrame: 3-month before the intervention and 3 month during intervention period.
Secondary outcomes:
measure: Involvement Rating Score
timeFrame: 3-month pilot intervention period.
measure: Patient Interviews
timeFrame: Up to 3-months post-intervention
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Family Health Centers of San Diego
state: California
Study officials:
affiliation: San Diego State University
name: Katrina Monroe, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Sara Gombatto, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: