NCT07290361 · San Diego State University
Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)
(STEPPT)
What this study is about
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).
View original scientific description
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.
Interventions
BEHAVIORAL
Engagement of clinic leadership (System Intervention - Usual Care)
No engagement of clinic leadership in promotion or monitoring of PT referral patterns among providers or PT adherence patterns among patients
BEHAVIORAL
Engagement of clinic leadership (System Intervention - STEPPT)
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.
BEHAVIORAL
Patient Registry (System Intervention - STEPPT)
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.
BEHAVIORAL
Delivery of Patient Education Materials (System Intervention - Usual Care)
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.
BEHAVIORAL
Delivery of Patient Education Materials (System Intervention - STEPPT)
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
BEHAVIORAL
Referral Specialist Training (System Intervention - Usual Care)
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.
BEHAVIORAL
Patient Health Navigator Training (System Intervention - STEPPT)
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.
BEHAVIORAL
Care Navigation (System Intervention - STEPPT)
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
BEHAVIORAL
Care navigation audit and feedback (System Intervention - STEPPT)
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.
BEHAVIORAL
Primary Care Provider training (Provider Intervention - STEPPT)
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)
BEHAVIORAL
Nurse/Medical Assistant Training (Provider Intervention - STEPPT)
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)
BEHAVIORAL
Provider feedback on PT referral and adherence (Provider Intervention - STEPPT)
Trends in PT referral and adherence rates, stratified by ethnicity, are reviewed biannually at "Provider Huddles" along with suggestions for improvement as needed.
BEHAVIORAL
Patient education on spine pain condition (Patient Intervention - Usual Care)
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. \[Available in English or Spanish language\]
BEHAVIORAL
Patient education on spine pain condition (Patient Intervention - STEPPT)
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. \[All patient education materials available in English or Spanish language\]
BEHAVIORAL
Patient Education on Physical Referral by Providers (Patient Intervention - Usual Care)
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.
BEHAVIORAL
Patient Education on Physical Referral by Providers (Patient Intervention - STEPPT)
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.
BEHAVIORAL
Electronic Patient Education on Physical Therapy Referral (Patient Intervention - STEPPT)
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. \[Eng/Span\]
BEHAVIORAL
Patient education on physical therapy referral by Referral Specialist (Patient Intervention - Usual Care)
Verbal patient education on physical therapy referral may be provided at the discretion of the Referral Specialist when scheduling the physical therapy consultation.
BEHAVIORAL
Patient education on physical therapy referral by Patient Health Navigator (Patient Intervention - STEPPT)
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.
BEHAVIORAL
Care Navigation (System Intervention - Usual Care)
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.
BEHAVIORAL
Monitoring of PT referral and adherence rates (System Intervention - STEPPT)
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.
BEHAVIORAL
Monitoring of PT referral and adherence rates (System intervention - Usual Care)
PT referral and adherence rates monitored as needed by Vice President of Specialty Services.
Primary outcome measures
Physical Therapy Referral
Time frame: Patient level: 3-months after index PCP encounter; Clinic level: 6-, 12-, 18-, and 24-months after start of trial
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.
Physical Therapy Adherence
Time frame: Patient level: 6-months after index physical therapy referral; Clinic level: 6-, 12-, 18-, and 24-months after start of trial
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 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.
Exclusion criteria
- 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
Where
- San Diego, California
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Family Health Centers of San Diego
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2026 · Source of record for eligibility and locations