Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)
NCT ID: NCT07290361
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
17587 participants
INTERVENTIONAL
2025-12-01
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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STEPPT Care Pathway
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.
Physical therapy referral and adherence monitoring (System Intervention - STEPPT)
Automated analysis of electronic health record monitors daily physical therapy referral and adherence rates for patient with spine pain. PowerBI custom graphical interface with monthly trends in physical therapy referral and adherence rates, stratified by ethnicity, are reviewed by Clinic Director and Charge Nurse. Monthly engagement meetings are conducted with medical leadership to review and support progress toward physical therapy referral and adherence goals.
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.
Delivery of Patient Education Materials (System Intervention - STEPPT)
Automated delivery systems for patient education materials include: (1) Auto-order for culturally tailored neck or back pain fact sheet and general physical therapy fact sheet printed in the after visit summary for all patients with a new or existing spine pain problem, (2) Auto-order for text message with links to culturally tailored physical therapy referral fact sheet and video upon referral to physical therapy for spine pain, and (3) Auto-order for culturally tailored neck and back pain fact sheet, general physical therapy fact sheet, postural exercise fact sheet, and physical therapy referral fact sheet and video added to the patient portal upon referral to physical therapy for spine pain
Engagement of clinic leadership (Systems Intervention - STEPPT)
Onboarding meeting with Clinic Directors and Charge Nurses to engage leadership in STEPPT objectives, procedures, and need for local adaptations. Medical leaders champion provider training and facilitate change in practice patterns through monthly review and discussion of trends in physical therapy referral and adherence patterns.
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.
Scheduling the physical therapy consultation (System Intervention - STEPPT)
Upon referral to physical therapy and verification of insurance coverage, patients in STEPPT registry receive a system-generated auto-call to schedule the physical therapy consultation. Auto-call is followed by up to 3 phone contact attempts by a Patient Health Navigator to 1) deliver enhanced care navigation, and 2) schedule the physical therapy consultation if not already scheduled during auto-call. If no contact is made after 3 attempts, a system-generated letter is sent by mail requesting the patient call a centralized Referral Specialist to schedule the physical therapy consultation
Enhanced Care Navigation (System Intervention - STEPPT)
Patient Health Navigator delivers culturally responsive, semi-scripted enhanced care navigation to identify and mitigate barriers for attending physical therapy when scheduling the physical therapy consultation. Mandatory components of enhanced care navigation include: (1) Summarize benefits of physical therapy, (2) Stress importance of attending physical therapy even if prescribed medication for temporary pain relief, (3) Confirm receipt and review of patient educational materials; resend materials if needed, (4) Address privacy concerns, if present, (5) Address scheduling, cost, and transportation barriers, if present, (6) Address other questions or concerns, (7) Schedule the physical therapy consultation, and (8) Repeat appointment details and provide contact information for additional questions
Care navigation audit and feedback (System Intervention - STEPPT)
Monthly audits of enhanced care navigation fidelity using self-report checklists and review of recorded phone calls are discussed with Patient Health Navigators to facilitate competent and consistent delivery of enhanced care navigation for patients in STEPPT registry.
Primary Care Provider training (Provider Intervention - STEPPT)
Primary care physicians attend an in-service presentation from the Director of Physical Rehabilitation Services on the following topics: (1) Benefits of physical therapy referral for patients with new and existing spine pain problems, (2) Low referral and adherence rates for physical therapy among Hispanic patients at Federally Qualified Health Center clinics, (3) Culturally responsive strategies to improve patient engagement in physical therapy services, and (4) Review of STEPPT objectives, procedures, and patient education materials.
Nurse/Medical Assistant Training (Provider Intervention - STEPPT)
Nurses and Medical Assistants attend an in-service presentation from the on the following topics: (1) Benefits of physical therapy referral for patients with new and existing spine pain problems, (2) Low referral and adherence rates for physical therapy among Hispanic patients at Federally Qualified Health Center clinics, (3) Culturally responsive strategies to improve patient engagement in physical therapy services, and (4) Review of STEPPT objectives, procedures, and patient education materials.
Feedback to Clinic Administrators (Provider Intervention - STEPPT)
Clinic administrators receive written reports on trends in physical therapy referral and adherence rates, stratified by ethnicity. Reports are reviewed by administrators and distributed to providers along with suggestions for improvement as needed.
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. \[All patient education materials available in English or Spanish language\]
Patient Education on Physical Referral by Providers (Patient Intervention - STEPPT)
Primary Care Physicians are encouraged to provide culturally responsive patient education on benefits of physical therapy for spine pain, while Nurses and Medical Assistants are encouraged to provide culturally responsive patient education on the referral process and importance of attending physical therapy at the index encounter. Patients are notified of referral for physical therapy consultation in the printed After Visit Summary at index encounter.
Electronic Patient Education on Physical Therapy Referral (Patient Intervention - STEPPT)
Upon referral to physical therapy, patients receive an automated text message and email with links to electronic patient education materials available online and in the patient portal. Education materials include (1) Physical Therapy Referral Factsheet, culturally tailored information highlighting the importance of attending physical therapy, resources to support attendance, and instructions for scheduling and preparing for the physical therapy consultation, and (2) Physical Therapy Education Video, a culturally tailored video showing how to schedule and attend physical therapy at the Federally Qualified Health Center. \[All education materials available in English or Spanish language\]
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.
Usual Care Pathway (Control)
The Usual Care Arm involves a medical evaluation by a primary care provider who may prescribe any combination of self-management advice, patient education, medication, physical therapy, chiropractic, or specialist care at the provider's discretion. If referred to physical therapy, a centralized Referral Specialist verifies insurance and attempts to schedule the evaluation. No culturally tailored education, enhanced navigation, or provider/staff training is provided beyond the current standard of care.
Physical therapy referral and adherence monitoring (System Intervention - Usual Care)
Physical therapy referral and adherence rates monitored as needed by Director of Physical Rehabilitation Services
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.
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.
Scheduling the Physical Therapy Consultation (System Intervention - Usual Care)
Upon physical therapy referral and verification of insurance coverage, patient receives system-generated auto-call to schedule the physical therapy consultation. Auto-call is followed by up to 3 phone contact attempts by Referral Specialist to schedule the physical therapy consultation if not scheduled during auto-call. If no contact is made after 3 attempts, a system-generated letter is sent by mail requesting the patient call a centralized Referral Specialist to schedule the physical therapyconsultation.
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. \[Available in English or Spanish language\]
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.
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.
Interventions
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Physical therapy referral and adherence monitoring (System Intervention - Usual Care)
Physical therapy referral and adherence rates monitored as needed by Director of Physical Rehabilitation Services
Physical therapy referral and adherence monitoring (System Intervention - STEPPT)
Automated analysis of electronic health record monitors daily physical therapy referral and adherence rates for patient with spine pain. PowerBI custom graphical interface with monthly trends in physical therapy referral and adherence rates, stratified by ethnicity, are reviewed by Clinic Director and Charge Nurse. Monthly engagement meetings are conducted with medical leadership to review and support progress toward physical therapy referral and adherence goals.
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.
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.
Delivery of Patient Education Materials (System Intervention - STEPPT)
Automated delivery systems for patient education materials include: (1) Auto-order for culturally tailored neck or back pain fact sheet and general physical therapy fact sheet printed in the after visit summary for all patients with a new or existing spine pain problem, (2) Auto-order for text message with links to culturally tailored physical therapy referral fact sheet and video upon referral to physical therapy for spine pain, and (3) Auto-order for culturally tailored neck and back pain fact sheet, general physical therapy fact sheet, postural exercise fact sheet, and physical therapy referral fact sheet and video added to the patient portal upon referral to physical therapy for spine pain
Engagement of clinic leadership (Systems Intervention - STEPPT)
Onboarding meeting with Clinic Directors and Charge Nurses to engage leadership in STEPPT objectives, procedures, and need for local adaptations. Medical leaders champion provider training and facilitate change in practice patterns through monthly review and discussion of trends in physical therapy referral and adherence patterns.
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.
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.
Scheduling the Physical Therapy Consultation (System Intervention - Usual Care)
Upon physical therapy referral and verification of insurance coverage, patient receives system-generated auto-call to schedule the physical therapy consultation. Auto-call is followed by up to 3 phone contact attempts by Referral Specialist to schedule the physical therapy consultation if not scheduled during auto-call. If no contact is made after 3 attempts, a system-generated letter is sent by mail requesting the patient call a centralized Referral Specialist to schedule the physical therapyconsultation.
Scheduling the physical therapy consultation (System Intervention - STEPPT)
Upon referral to physical therapy and verification of insurance coverage, patients in STEPPT registry receive a system-generated auto-call to schedule the physical therapy consultation. Auto-call is followed by up to 3 phone contact attempts by a Patient Health Navigator to 1) deliver enhanced care navigation, and 2) schedule the physical therapy consultation if not already scheduled during auto-call. If no contact is made after 3 attempts, a system-generated letter is sent by mail requesting the patient call a centralized Referral Specialist to schedule the physical therapy consultation
Enhanced Care Navigation (System Intervention - STEPPT)
Patient Health Navigator delivers culturally responsive, semi-scripted enhanced care navigation to identify and mitigate barriers for attending physical therapy when scheduling the physical therapy consultation. Mandatory components of enhanced care navigation include: (1) Summarize benefits of physical therapy, (2) Stress importance of attending physical therapy even if prescribed medication for temporary pain relief, (3) Confirm receipt and review of patient educational materials; resend materials if needed, (4) Address privacy concerns, if present, (5) Address scheduling, cost, and transportation barriers, if present, (6) Address other questions or concerns, (7) Schedule the physical therapy consultation, and (8) Repeat appointment details and provide contact information for additional questions
Care navigation audit and feedback (System Intervention - STEPPT)
Monthly audits of enhanced care navigation fidelity using self-report checklists and review of recorded phone calls are discussed with Patient Health Navigators to facilitate competent and consistent delivery of enhanced care navigation for patients in STEPPT registry.
Primary Care Provider training (Provider Intervention - STEPPT)
Primary care physicians attend an in-service presentation from the Director of Physical Rehabilitation Services on the following topics: (1) Benefits of physical therapy referral for patients with new and existing spine pain problems, (2) Low referral and adherence rates for physical therapy among Hispanic patients at Federally Qualified Health Center clinics, (3) Culturally responsive strategies to improve patient engagement in physical therapy services, and (4) Review of STEPPT objectives, procedures, and patient education materials.
Nurse/Medical Assistant Training (Provider Intervention - STEPPT)
Nurses and Medical Assistants attend an in-service presentation from the on the following topics: (1) Benefits of physical therapy referral for patients with new and existing spine pain problems, (2) Low referral and adherence rates for physical therapy among Hispanic patients at Federally Qualified Health Center clinics, (3) Culturally responsive strategies to improve patient engagement in physical therapy services, and (4) Review of STEPPT objectives, procedures, and patient education materials.
Feedback to Clinic Administrators (Provider Intervention - STEPPT)
Clinic administrators receive written reports on trends in physical therapy referral and adherence rates, stratified by ethnicity. Reports are reviewed by administrators and distributed to providers along with suggestions for improvement as needed.
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. \[Available in English or Spanish language\]
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. \[All patient education materials available in English or Spanish language\]
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.
Patient Education on Physical Referral by Providers (Patient Intervention - STEPPT)
Primary Care Physicians are encouraged to provide culturally responsive patient education on benefits of physical therapy for spine pain, while Nurses and Medical Assistants are encouraged to provide culturally responsive patient education on the referral process and importance of attending physical therapy at the index encounter. Patients are notified of referral for physical therapy consultation in the printed After Visit Summary at index encounter.
Electronic Patient Education on Physical Therapy Referral (Patient Intervention - STEPPT)
Upon referral to physical therapy, patients receive an automated text message and email with links to electronic patient education materials available online and in the patient portal. Education materials include (1) Physical Therapy Referral Factsheet, culturally tailored information highlighting the importance of attending physical therapy, resources to support attendance, and instructions for scheduling and preparing for the physical therapy consultation, and (2) Physical Therapy Education Video, a culturally tailored video showing how to schedule and attend physical therapy at the Federally Qualified Health Center. \[All education materials available in English or Spanish language\]
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Family Health Centers of San Diego
OTHER
San Diego State University
OTHER
Responsible Party
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Katrina Monroe
PT, PhD
Principal Investigators
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Katrina Monroe, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
San Diego State University
Sara Gombatto, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
San Diego State University Research Foundation
Locations
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Family Health Centers of San Diego
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Job Godino, PhD
Role: primary
Shadia Assi, BS, MPH
Role: backup
Other Identifiers
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HS-2023-0122
Identifier Type: -
Identifier Source: org_study_id