Development of STEPPT

NCT06835439 | Active Not Recruiting

• 2 other identifiers: IRB-24-0391R01MD018937
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Back Pain; Low Back Pain; Chronic Pain; Neck Pain

Keywords

Physical therapy; Rehabilitation; Hispanic; Health disparities; Health services; Healthcare utilization

Outcome Measures

Primary Outcomes (2)

• Ethnic Disparity in Rate of Physician Referral to Physical Therapy

  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).

  3-month before the intervention and 3 month during intervention period.

• Ethnic Disparity in Rate of Patient Adherence to Physical Therapy Referral

  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).

  3-month before the intervention and 3 month during intervention period.

Secondary Outcomes (2)

• Involvement Rating Score

  3-month pilot intervention period.

• Patient Interviews

  Up to 3-months post-intervention

Study Arms (2)

STEPPT Intervention

EXPERIMENTAL

Participants in this arm will receive 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, and (3) enhanced patient health navigation to educate patients and address barriers to attending physical therapy for Hispanic patients with spine pain. The goal is to reduce ethnic disparities by improving physical therapy referral and adherence rates for Hispanic patients with spine pain.

Behavioral: STEPPT Pilot

Standard Care (Control)

ACTIVE COMPARATOR

Standard care during the 3-month baseline period, prior to implementing the STEPPT intervention, will be the active comparator arm. Ethnic disparities in referral and adherence rates will be compared between the 3-month baseline period and the 3-month intervention period to estimate the effect size of the pilot STEPPT intervention for reducing ethnic disparities in physical therapy referral and adherence outcomes.

Behavioral: Standard Care (Control)

Interventions

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.

STEPPT Intervention

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.

Standard Care (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Family Health Centers of San Diego: collaborator

Study Sites (1)

Family Health Centers of San Diego

San Diego, California, 92102, United States

Location

MeSH Terms

Conditions

Pain; Back Pain; Low Back Pain; Chronic Pain; Neck Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Katrina Monroe, PT, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Sara Gombatto, PT, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 19, 2025
• Study Start: November 2, 2024
• Primary Completion: April 30, 2025
• Study Completion: November 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)