Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07290361

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Low Back Pain Back Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Health Centers of San Diego

San Diego, California, 92182, United States

Location status: Recruiting

Location contact

Jason Van Dyke, MSPT

SUB_INVESTIGATOR

Job Godino, PhD

CONTACT

[email protected]

619-515-2344 ext. 2344

Shadia Assi, BS, MPH

CONTACT

[email protected]

619-515-2300 ext. 3337

About this study

This study will examine the implementation and effectiveness of STEPPT for improving access and engagement of Hispanic patients with spine pain in physical therapy (PT) services at a Federally Qualified Health Center (FQHC) serving low-income communities near the United States-Mexico border. A pragmatic hybrid type I stepped wedge cluster randomized trial (SW-CRT) will be conducted to examine the effectiveness of STEPPT for increasing rates of PT referral and adherence as a primary aim. The study will also explore implementation outcomes to better understand the context of enacting a targeted intervention to engage medically underserved populations as a secondary aim. Nine FQHC Primary Care clinics (clusters) will be randomized to three implementation steps, with three clinics allocated per step, using a covariate-constrained randomization approach. To minimize imbalance between steps, allocation of clinics will be balanced with respect to clinic size and historical rates of PT referral and adherence in the year prior to allocation. For each candidate allocation, an imbalance score summarizing differences across steps will be calculated and the randomization procedure will be repeated to identify the allocation yielding the smallest overall imbalance score as the final stepped-wedge assignment. The three steps will transition from Usual Care (control) to STEPPT (intervention) at 6-month intervals. A 6-month baseline period of Usual Care for all clinics will precede the first date of cross over into STEPPT. Implementation and effectiveness outcomes will be assessed at 6-month intervals throughout the trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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.

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.

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

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.

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.

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

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.

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)

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)

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.

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]

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]

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.

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.

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]

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.

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.

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.

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Maintenance Physical Therapy Referral

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

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

  2. Maintenance Physical Therapy Adherence

    Time frame: Patient level: 6-months after index physical therapy referral; Clinic level: 30-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 during the maintenance phase.

  3. Patient age

    Time frame: Upon enrollment

    Patient age in years recorded in electronic health record

  4. Patient sex

    Time frame: Upon enrollment

    Patient sex at birth recorded in electronic health record

  5. Patient race

    Time frame: Upon enrollment

    Patient race recorded in electronic health record

  6. Patient ethnicity

    Time frame: Upon enrollment

    Patient ethnicity recorded in electronic health record

  7. Patient birth place

    Time frame: Upon enrollment

    Patient country of birth recorded in electronic health record

  8. Patient education

    Time frame: Upon enrollment

    Patient highest level of education recorded in electronic health record

  9. Patient employment

    Time frame: Upon enrollment

    Patient employment status recorded in electronic health record

  10. Patient relationship status

    Time frame: Upon enrollment

    Patient relationship status (e.g., married, divorced, etc.) recorded in electronic health record

  11. Patient neighborhood status

    Time frame: Upon enrollment

    Neighborhood healthy places index (HPI) score based on patient zipcode

  12. Patient food insecurity

    Time frame: Upon enrollment

    Patient food insecurity status based on PREPAR questionnaire recorded in electronic health record

  13. Patient transportation status

    Time frame: Upon enrollment

    Patient transportation status based on PRAPARE questionnaire recorded in electronic health record

  14. Patient insurance

    Time frame: Upon enrollment

    Patient insurance status (federal, private, uninsured, etc.) recorded in electronic health record

  15. Patient language

    Time frame: Upon enrollment

    Patient preferred language recorded in electronic health record

  16. Patient interpreter

    Time frame: Upon enrollment

    Patient request for interpreter during primary care visit recorded in electronic health record

  17. Index clinic

    Time frame: Upon enrollment

    Name of Federally Qualified Health Center clinic at which index encounter for spine pain occurred recorded in electronic health record

  18. Spine pain region

    Time frame: Upon enrollment

    Region of spine pain (neck, low back, both) recorded in electronic health record at index encounter

  19. Spine pain acuity

    Time frame: Upon enrollment

    New or existing spine pain problem recorded in electronic health record at index encounter

  20. Patient comorbidity

    Time frame: Upon enrollment

    Functional comorbidity index recorded in electronic health record

  21. Patient existing prescriptions

    Time frame: Upon enrollment

    Type and number of existing prescriptions recorded in electronic health record at index encounter

  22. Patient new prescriptions

    Time frame: Upon enrollment

    Type and number of new prescriptions recorded in electronic health record at index encounter

  23. Patient referrals

    Time frame: Upon enrollment

    Type and number of specialty referrals recorded in electronic health record at index encounter

  24. Clinic size

    Time frame: Upon crossover to STEPPT

    Number of spine pain encounters during baseline period for each participating primary care clinic

  25. Clinic location

    Time frame: Upon crossover to STEPPT

    Geographic location of each participating primary care clinic

  26. Clinic PT Services

    Time frame: Upon crossover to STEPPT

    Availability of onsite physical therapy services for each participating primary care clinic

  27. Provider age

    Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial

    Ages of primary care providers employed at each participating clinic recorded in clinic operations records

  28. Provider sex

    Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial

    Sex of primary care providers employed at each participating clinic recorded in clinic operations records

  29. Provider race

    Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial

    Races of primary care providers employed at each participating clinic recorded in clinic operations records

  30. Provider ethnicity

    Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial

    Ethnicities of primary care providers employed at each participating clinic recorded in clinic operations records

  31. Provider education

    Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial

    Highest clinical degrees for primary care providers employed at participating clinics recorded in clinic operations records

  32. Provider specialty

    Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial

    Types of clinical specialties for primary care providers employed at each participating clinic recorded in clinic operations records

  33. Provider experience

    Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial

    Time elapsed between date of highest clinical degree for primary care providers at each participating clinic and date of index encounter

  34. Duration of provider employment

    Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial

    Duration of employment at federally qualified health center for primary care providers at each participating clinic recorded in clinical operations records

  35. PCP frequency of PT education

    Time frame: Prior to training, 6-months after crossover to STEPPT

    Primary care physician self-reported frequency of educating patients with spine pain about the benefits of physical therapy (never, rarely, sometimes, often, always)

  36. PCP qualitative interviews

    Time frame: 3-months after cross over to STEPPT

    Qualitative interviews with primary care providers to assess motivations, barriers, and facilitators for any changes made in the rate of physical therapy referral and the frequency, content, and approach for patient education on benefits of physical therapy

  37. Allied provider frequency of PT education

    Time frame: Prior to training, 6-months after crossover to STEPPT

    Nurse and Medical Assistant self-reported frequency of educating patients about the benefits of physical therapy and referral process (never, rarely, sometimes, often, always)

  38. Allied provider qualitative interviews

    Time frame: 3-months after cross over to STEPPT

    Qualitative interviews with nurses and medical assistants to assess motivations, barriers, and facilitators for any changes made in the rate of physical therapy referral and the frequency, content, and approach for patient education on benefits of physical therapy

  39. Training Involvement Rating Scale (IRS) score

    Time frame: 6-, 12-, 18-months after start of trial

    Scale ranging from 0-15 points quantifies unsatisfactory (0-5 points), moderate (6-10 points) and satisfactory (11-15 points) involvement of clinic staff in STEPPT trainings. IRS score assesses the following training domains: 1) clinic administrator orientation, 2) primary care physician orientation, 3) Nurse/Medical Assistant orientation, 4) Review of progress reports, 5) ECN training and audit reviews

  40. ECN contact attempts

    Time frame: 12-, 18-, 24-, and 30-months after start of trial

    Number of enhanced care navigation call attempts prior to scheduling first physical therapy appointment

  41. ECN completed contacts

    Time frame: 12-, 18-, 24-, and 30-months after start of trial

    Proportion of Hispanic patients referred to physical therapy who were able to be contacted by patient health navigator, regardless of whether enhanced care navigation was delivered

  42. ECN delivery

    Time frame: 12-, 18-, 24-, and 30-months after start of trial

    Proportion of Hispanic patients who were successfully contacted for whom each mandatory component of enhanced care navigation was delivered

  43. Order Printed PT Education Materials

    Time frame: 12-, 18-, 24-, and 30-months after start of trial

    Proportion of Hispanic patients with a new or existing spine pain problem who receive an auto-order for physical therapy education materials printed with the after visit summary at index encounter

  44. Order Portal PT Education Materials

    Time frame: 12-, 18-, 24-, and 30-months after start of trial

    Proportion of Hispanic patients referred to physical therapy who receive an auto-order for electronic physical therapy education materials, referral information, and educational video in the patient portal

  45. Order Text PT Education Materials

    Time frame: 12-, 18-, 24-, and 30-months after start of trial

    Proportion of Hispanic patients referred to physical therapy who are sent an auto-order for text link to physical therapy referral information and education video

  46. Patient Portal Views

    Time frame: 12-, 18-, 24-, and 30-months after start of trial

    Proportion of Hispanic patients referred to physical therapy who view electronic physical therapy education materials, referral information, and education video from links provided in patient portal

  47. Patient Text Views

    Time frame: 12-, 18-, 24-, and 30-months after start of trial

    Proportion of Hispanic patients referred to physical therapy who view physical therapy referral information and education video from links provided from the auto-text message

Study contacts

Contact information is provided by the study sponsor or research team.

Cheenee R Real, BSN, MPH, MSOL

CONTACT

[email protected]

323-508-6312

Shadia Assi, BS, MPH

CONTACT

[email protected]

619-515-2300 ext. 3337

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • Family Health Centers of San Diego
  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT): A Pragmatic Stepped Wedge Cluster Randomized Trial

Acronym: STEPPT

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Dec 18, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.