Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)

NCT07290361 | Recruiting

• 2 other identifiers: HS-2023-0122R01MD018937
• Study Type: interventional
• Target: 17,587
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a health system intervention called "Stratified Targeted Engagement from Primary Care to Physical Therapy (STEPPT)" can improve how often doctors refer Hispanic patients with spine pain to physical therapy (referral rate) and how often patients attend physical therapy after being referred (adherence rate). The main questions this study aims to answer are 1) does STEPPT improve physical therapy referral and adherence rates compared to usual care for Hispanic patients with spine pain who seek care in a Federally Qualified Health Center (FQHC) serving low income communities, and 2) how consistently do FQHC providers and staff deliver STEPPT to patients who may benefit? STEPPT will train doctors and other health care providers to educate participants on the benefits of physical therapy for spine pain and participants will receive culturally tailored handouts and videos to teach them about their spine pain and what to expect in physical therapy. Patients will also receive personalized assistance to schedule their physical therapy appointment and address potential barriers for attending the appointment.

Conditions

Low Back Pain; Neck Pain

Keywords

Physical therapy; Rehabilitation; Hispanic; Heatlh Services; Healthcare utilization; Federally Qualified Health Center

Outcome Measures

Primary Outcomes (2)

• Physical Therapy Referral

  Proportion of enrolled patients who receive an internal or external referral to physical therapy following Primary Care Provider (PCP) index encounter for a new or existing episode of spine pain.

  Patient level: 3-months after index PCP encounter; Clinic level: 6-, 12-, 18-, and 24-months after start of trial

• Physical Therapy Adherence

  Proportion of enrolled patients who complete a physical therapy evaluation at the Federally Qualified Health Center following an internal referral to physical therapy for a new or existing episode of spine pain.

  Patient level: 6-months after index physical therapy referral; Clinic level: 6-, 12-, 18-, and 24-months after start of trial

Secondary Outcomes (47)

• Maintenance Physical Therapy Referral

  Patient level: 3-months after index PCP encounter; Clinic level: 30-months after start of trial

• Maintenance Physical Therapy Adherence

  Patient level: 6-months after index physical therapy referral; Clinic level: 30-months after start of trial

• Patient age

  Upon enrollment

• Patient sex

  Upon enrollment

• Patient race

  Upon enrollment

Study Arms (2)

STEPPT Care Pathway

EXPERIMENTAL

The STEPPT Care Pathway is a multi-level intervention designed to improve physical therapy (PT) referral and adherence among Hispanic patients with spine pain in Federally Qualified Health Center. STEPPT includes: 1) provider training and feedback through brief in-service education on guideline-based referral and culturally responsive communication about the benefits of PT for spine pain, 2) delivery of culturally tailored patient education materials in English and Spanish via print, video, and digital platforms, and 3) enhanced care navigation by bilingual Patient Health Navigators who provide personalized outreach, barrier mitigation, and scheduling support. System-level enhancements include automated electronic health record tools for patient identification, registry tracking, and delivery of education materials to ensure timely referral and engagement in PT services.

Behavioral: Engagement of clinic leadership (System Intervention - STEPPT); Behavioral: Patient Registry (System Intervention - STEPPT); Behavioral: Delivery of Patient Education Materials (System Intervention - STEPPT); Behavioral: Patient Health Navigator Training (System Intervention - STEPPT); Behavioral: Care Navigation (System Intervention - STEPPT); Behavioral: Care navigation audit and feedback (System Intervention - STEPPT); Behavioral: Primary Care Provider training (Provider Intervention - STEPPT); Behavioral: Nurse/Medical Assistant Training (Provider Intervention - STEPPT); Behavioral: Provider feedback on PT referral and adherence (Provider Intervention - STEPPT); Behavioral: Patient education on spine pain condition (Patient Intervention - STEPPT); Behavioral: Patient Education on Physical Referral by Providers (Patient Intervention - STEPPT); Behavioral: Electronic Patient Education on Physical Therapy Referral (Patient Intervention - STEPPT); Behavioral: Patient education on physical therapy referral by Patient Health Navigator (Patient Intervention - STEPPT); Behavioral: Monitoring of PT referral and adherence rates (System Intervention - STEPPT)

Usual Care Pathway (Control)

ACTIVE COMPARATOR

The Usual Care Arm involves the current institutional standard of referral and scheduling processes. If a patient is referred to physical therapy, a centralized Referral Specialist verifies insurance and attempts to schedule the evaluation. No provider/staff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.

Behavioral: Engagement of clinic leadership (System Intervention - Usual Care); Behavioral: Delivery of Patient Education Materials (System Intervention - Usual Care); Behavioral: Referral Specialist Training (System Intervention - Usual Care); Behavioral: Patient education on spine pain condition (Patient Intervention - Usual Care); Behavioral: Patient Education on Physical Referral by Providers (Patient Intervention - Usual Care); Behavioral: Patient education on physical therapy referral by Referral Specialist (Patient Intervention - Usual Care); Behavioral: Care Navigation (System Intervention - Usual Care); Behavioral: Monitoring of PT referral and adherence rates (System intervention - Usual Care)

Interventions

Engagement of clinic leadership (System Intervention - STEPPT) BEHAVIORAL

Clinic Directors and Charge Nurses engage in STEPPT onboarding meeting with STEPPT Project Manager to discuss STEPPT objectives, procedures, and need for local adaptations. Medical leaders champion provider training and facilitate change in practice patterns through regularly scheduled review of trends in PT referral and adherence patterns with STEPPT Project Manager.

STEPPT Care Pathway

Patient Registry (System Intervention - STEPPT) BEHAVIORAL

Patients referred to physical therapy for spine pain are stratified by ethnicity. Hispanic patients are added to STEPPT Patient Registry to facilitate targeted engagement of an underserved population known to have low rates of adherence for physical therapy referrals.

STEPPT Care Pathway

Delivery of Patient Education Materials (System Intervention - Usual Care) BEHAVIORAL

Neck or back pain fact sheet may be manually ordered in the printed after visit summary at the discretion of the primary care physician. No automated systems for delivery of patient education materials on spine pain or physical therapy referral.

Usual Care Pathway (Control)

Delivery of Patient Education Materials (System Intervention - STEPPT) BEHAVIORAL

Automated delivery systems for patient education materials include: * Auto-order for culturally tailored neck or back pain fact sheet, general PT fact sheet, and postural exercise fact sheet printed in the AVS for all Hispanic patients with a new or existing spine pain problem * Auto-order for text message with links to culturally tailored PT referral fact sheet and video upon referral to PT for spine pain * Auto-order for culturally tailored neck or back pain fact sheet, general PT fact sheet, postural exercise fact sheet, PT referral fact sheet, and video added to the patient portal upon referral to PT for spine pain

STEPPT Care Pathway

Referral Specialist Training (System Intervention - Usual Care) BEHAVIORAL

Referral Specialists trained in system-wide procedures for processing referrals, calling patients, and scheduling appointments for specialty services. Physical therapy referrals processed by a dedicated team of Physical Rehabilitation Services Referral Specialists.

Usual Care Pathway (Control)

Care Navigation (System Intervention - STEPPT) BEHAVIORAL

Upon referral to PT and verification of insurance coverage, patients receive a system-generated auto-call to schedule the PT evaluation followed by up to 3 phone contact attempts by a Patient Health Navigator (PHN) to 1) deliver enhanced care navigation, and 2) schedule PT evaluation. Prior to scheduling, PHN delivers semi-scripted enhanced care navigation (ECN) with mandatory components: * Summarize benefits of PT * Emphasize importance of attending PT even if prescribed medication for temporary pain relief * Confirm patient received and reviewed educational materials. Resend materials, if needed * Address privacy concerns, if present * Address risk factors for PT non-adherence, if present: scheduling, cost, transportation barriers * Address other questions or concerns * Schedule the PT evaluation * Repeat appointment details and provide PHN contact information for additional questions

STEPPT Care Pathway

Care navigation audit and feedback (System Intervention - STEPPT) BEHAVIORAL

Audits of fidelity to enhanced care navigation protocol using self-report checklists and review of recorded phone calls are discussed monthly with PHNs to facilitate competent and consistent delivery of enhanced care navigation for patients in STEPPT registry.

STEPPT Care Pathway

Primary Care Provider training (Provider Intervention - STEPPT) BEHAVIORAL

PCPs attend training with Physical Rehabilitation Services site manager on the following topics: * STEPPT objectives, procedures, and patient education materials * Referral and adherence rates for PT among Hispanic patients at FQHC clinics * Benefits of PT referral for patients with new and existing spine pain problems * Culturally responsive strategies to improve patient engagement in PT services (e.g., explanation of how PT can improve family and social role functioning)

STEPPT Care Pathway

Nurse/Medical Assistant Training (Provider Intervention - STEPPT) BEHAVIORAL

Nurses and MAs attend training with Physical Rehabilitation Services site manager on the following topics: * STEPPT objectives, procedures, and patient education materials * Referral and adherence rates for PT among Hispanic patients at FQHC clinics * Benefits of PT referral for patients with new and existing spine pain problems * Culturally responsive strategies to improve patient engagement in PT services (e.g., explanation of the FQHC referral process)

STEPPT Care Pathway

Patient education on spine pain condition (Patient Intervention - Usual Care) BEHAVIORAL

Verbal patient education on etiology, treatment, and prognosis for spine pain may be provided at the discretion of Primary Care Physician. Back Pain or Neck Pain Fact Sheet may be ordered in the printed After Visit Summary at the discretion of Primary Care Physician. Back Pain/Neck Pain Factsheet summarizes current evidence on etiology, prognosis, and treatment (medical and self-management) for back or neck pain. \[Available in English or Spanish language\]

Usual Care Pathway (Control)

Patient Education on Physical Referral by Providers (Patient Intervention - Usual Care) BEHAVIORAL

Verbal patient education on physical therapy referral may be provided at the discretion of Primary Care Physician, Nurse, and/or Medical Assistant at index encounter. Patients are notified of referral for physical therapy consultation in the printed After Visit Summary. No written instructions on physical therapy referral process are provided.

Usual Care Pathway (Control)

Electronic Patient Education on Physical Therapy Referral (Patient Intervention - STEPPT) BEHAVIORAL

Patient receives auto-email from patient portal and auto-text message with links to electronic patient education materials upon being referred to PT: * Physical Therapy Referral Information - Culturally tailored information highlighting the importance of attending PT, resources to support regular attendance, and instructions for scheduling and preparing for the PT evaluation. \[Eng/Span\] * Physical Therapy Education Video - Culturally tailored video showing how to schedule and attend the PT evaluation with testimonials from former FQHC patients highlighting benefits of PT for spine pain. \[Eng/Span\]

STEPPT Care Pathway

Patient education on physical therapy referral by Referral Specialist (Patient Intervention - Usual Care) BEHAVIORAL

Verbal patient education on physical therapy referral may be provided at the discretion of the Referral Specialist when scheduling the physical therapy consultation.

Usual Care Pathway (Control)

Patient education on physical therapy referral by Patient Health Navigator (Patient Intervention - STEPPT) BEHAVIORAL

Culturally responsive, semi-scripted patient education on benefits of physical therapy and logistics of physical therapy appointments provided verbally by a Patient Health Navigator (PHN) when scheduling the physical therapy consultation. PHN identifies and helps mitigate individual barriers for attending physical therapy appointments.

STEPPT Care Pathway

Care Navigation (System Intervention - Usual Care) BEHAVIORAL

Upon PT referral and verification of insurance coverage, patient receives up to 2 system-generated auto-calls to schedule PT evaluation. If no contact is made after 30 days, a system-generated letter is sent by mail requesting the patient call a centralized Referral Specialist to schedule the PT evaluation. Additional care navigation services may be provided at the discretion of the Referral Specialist.

Usual Care Pathway (Control)

Monitoring of PT referral and adherence rates (System Intervention - STEPPT) BEHAVIORAL

Automated EHR analysis monitors daily PT referral and adherence rates for spine pain. PowerBI custom graphical interface with monthly trends in PT referral and adherence rates, stratified by ethnicity, are reviewed biannually by Vice President of Specialty Services, Physical Rehabilitation Services site manager, medical leadership, and providers.

STEPPT Care Pathway

Engagement of clinic leadership (System Intervention - Usual Care) BEHAVIORAL

No engagement of clinic leadership in promotion or monitoring of PT referral patterns among providers or PT adherence patterns among patients

Usual Care Pathway (Control)

Patient Health Navigator Training (System Intervention - STEPPT) BEHAVIORAL

Patient Health Navigators (PHNs) trained in system-wide procedures for processing referrals, calling patients, and scheduling appointments for specialty services. Additional training on patient communication and enhanced care navigation is provided to address cultural factors, individual barriers, and risk factors for non-adherence. Physical therapy referrals processed by a specially trained team of Physical Rehabilitation Services PHNs.

STEPPT Care Pathway

Provider feedback on PT referral and adherence (Provider Intervention - STEPPT) BEHAVIORAL

Trends in PT referral and adherence rates, stratified by ethnicity, are reviewed biannually at "Provider Huddles" along with suggestions for improvement as needed.

STEPPT Care Pathway

Patient education on spine pain condition (Patient Intervention - STEPPT) BEHAVIORAL

Verbal patient education on etiology, treatment, and prognosis for spine pain may be provided at the discretion of Primary Care Physician. Patient education materials auto-ordered in the printed After Visit Summary for all patients with a new or existing spine pain problem on the electronic health record Problem List. STEPPT patient education materials include: (1) Back Pain or Neck Pain Facts, a culturally tailored factsheet summarizing current evidence on etiology, prognosis, and treatment (medical and self-management) for back or neck pain, (2) Physical Therapy Fact Sheet, culturally tailored information describing physical therapy evaluation and treatment options for pain with a QR code linking to a Physical Therapy Education Video, (3) Posture Exercises, culturally tailored instructions for standing posture, seated posture, and supine diaphragmatic breathing. \[All patient education materials available in English or Spanish language\]

STEPPT Care Pathway

Patient Education on Physical Referral by Providers (Patient Intervention - STEPPT) BEHAVIORAL

Following training in best practices, primary care providers encouraged to provide culturally responsive patient education on benefits of PT for spine pain at index encounter. Nurses and medical assistants encouraged to review printed patient education materials on benefits of PT and institutional referral process. Patients are notified of referral for physical therapy consultation in the printed After Visit Summary at index encounter.

STEPPT Care Pathway

Monitoring of PT referral and adherence rates (System intervention - Usual Care) BEHAVIORAL

PT referral and adherence rates monitored as needed by Vice President of Specialty Services.

Usual Care Pathway (Control)

Eligibility Criteria

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

You may qualify if:

• years or older.
• Identify as either Hispanic or Non-Hispanic ethnicity, inclusive of all races.
• Seeking care for spine pain at an Adult or Adult Walk-in primary care clinic within the participating Federally Qualified Health Center (FQHC).
• New or existing spine pain problem: A new spine pain problem is defined by a new ICD code for neck or back pain added to the problem list during a visit with a primary care physician. An existing spine pain problem is defined by 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.
• Signed a broad consent for the use of de-identified health information for research at the participating FQHC.

You may not qualify if:

• Spine pain associated with a non-musculoskeletal etiology (e.g., infection, cancer, urological disorders, pregnancy, etc.)
• Patients requiring urgent medical intervention (e.g., fracture, cauda equina syndrome, etc)
• Active physical therapy referral for spine pain at the time of the index encounter.
• Previously referred to physical therapy through the STEPPT Care Pathway.
• Physical therapy referrals external to the FQHC will be 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, 92182, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Neck Pain

Interventions

Nurses

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Katrina Monroe, PT, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Sara Gombatto, PT, PhD

  San Diego State University Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheenee R Real, BSN, MPH, MSOL

CONTACT

323-508-6312; creal2@sdsu.edu

Shadia Assi, BS, MPH

CONTACT

619-515-2300; shadiaa@fhcsd.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The STEPPT trial will use single blind masking in which patients will remain blind to the study purpose and alternate care pathways (STEPPT Care vs. Usual Care) throughout the trial. Providers and clinic staff cannot be blinded due to the nature of the intervention (i.e., providers and staff require training to administer STEPPT and implement workflow changes). The order of cross-over from Usual Care to STEPPT will be concealed from investigators, providers, and staff until one month prior to each step in the SW-CRT. At this time, the statistician will communicate the clinics that have been randomly assigned to cross over to the FQHC Research Manager who will then initiate training activities which will unblind providers and staff. Primary and secondary outcomes will be assessed using automated algorithms applied to electronic health record (EHR) data to minimize bias. Investigators, providers, and staff will have access to these data for feedback and quality improvement purposes.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Model Details: The STEPPT study will use a hybrid type 1, pragmatic stepped wedge cluster randomized trial (SW-CRT) design to evaluate implementation and effectiveness of a multi-level intervention aimed at improving rates of physical therapy referral and adherence among Hispanic patients with spine pain at a Federally Qualified Health Center. The unit of randomization is clinics. Outcomes will be assessed at the participant level.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 12 months after publication of primary results and for a period of 5 years thereafter.
• Access Criteria: Researchers must submit a written request and scientific justification for access to IPD and provide a data use agreement outlining compliance with confidentiality and ethical standards. Requests will be reviewed by the multiple principal investigator team and the FQHC research oversight committee. If approved, access will be granted through permissions in the Open Science Framework repository. Supporting materials will include the study protocol, data dictionaries, statistical analysis plan, and intervention materials.

Locations

US (1)