Development of STEPPT

NCT ID: NCT06835439

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-02
• Study Completion Date: 2025-11-30

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

STEPPT Intervention

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.

Group Type: EXPERIMENTAL

STEPPT Pilot

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Standard Care (Control)

Intervention Type: 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.

Interventions

STEPPT Pilot

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.

Intervention Type: BEHAVIORAL

Standard Care (Control)

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Family Health Centers of San Diego

OTHER

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katrina Monroe, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Sara Gombatto, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

Family Health Centers of San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

R01MD018937

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-24-0391

Identifier Type: -

Identifier Source: org_study_id