Low Back PainSTEPPTNCT07290361
Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)
A study testing Engagement of clinic leadership (System Intervention - STEPPT), Patient Registry (System Intervention - STEPPT) and Delivery of Patient Education Materials (System Intervention - STEPPT) in people with Low Back Pain and Neck Pain, run by San Diego State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Neck Pain
- What is being tested?
- Engagement of clinic leadership (System Intervention - STEPPT), Patient Registry (System Intervention - STEPPT) and Delivery of Patient Education Materials (System Intervention - STEPPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,587 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Family Health Centers of San Diego
San Diego, California, 92182
Job Godino, PhD, 619-515-2344 ext. 2344, jobg@fhcsd.org
Shadia Assi, BS, MPH, 619-515-2300 ext. 3337, shadiaa@fhcsd.org
About this study
Official title: Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT): A Pragmatic Stepped Wedge Cluster Randomized Trial
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.
Read the detailed description
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.
- Conditions
- Low Back Pain, Neck Pain
- Being tested
- Engagement of clinic leadership (System Intervention - Usual Care), Engagement of clinic leadership (System Intervention - STEPPT), Patient Registry (System Intervention - STEPPT), Delivery of Patient Education Materials (System Intervention - Usual Care), Delivery of Patient Education Materials (System Intervention - STEPPT)
- Keywords
- Physical therapy, Rehabilitation, Hispanic, Heatlh Services, Healthcare utilization, Federally Qualified Health Center
- Medical subject headings
- Low Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engagement of clinic leadership (System Intervention - Usual Care)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
PT referral and adherence rates monitored as needed by Vice President of Specialty Services.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Patient level: 3-months after index PCP encounter; Clinic level: 30-months after start of trial
Maintenance 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 during the maintenance phase.
Measured: Patient level: 6-months after index physical therapy referral; Clinic level: 30-months after start of trial
Patient age
Patient age in years recorded in electronic health record
Measured: Upon enrollment
Patient sex
Patient sex at birth recorded in electronic health record
Measured: Upon enrollment
Patient race
Patient race recorded in electronic health record
Measured: Upon enrollment
Patient ethnicity
Patient ethnicity recorded in electronic health record
Measured: Upon enrollment
Patient birth place
Patient country of birth recorded in electronic health record
Measured: Upon enrollment
Patient education
Patient highest level of education recorded in electronic health record
Measured: Upon enrollment
Patient employment
Patient employment status recorded in electronic health record
Measured: Upon enrollment
Patient relationship status
Patient relationship status (e.g., married, divorced, etc.) recorded in electronic health record
Measured: Upon enrollment
Patient neighborhood status
Neighborhood healthy places index (HPI) score based on patient zipcode
Measured: Upon enrollment
Patient food insecurity
Patient food insecurity status based on PREPAR questionnaire recorded in electronic health record
Measured: Upon enrollment
Patient transportation status
Patient transportation status based on PRAPARE questionnaire recorded in electronic health record
Measured: Upon enrollment
Patient insurance
Patient insurance status (federal, private, uninsured, etc.) recorded in electronic health record
Measured: Upon enrollment
Patient language
Patient preferred language recorded in electronic health record
Measured: Upon enrollment
Patient interpreter
Patient request for interpreter during primary care visit recorded in electronic health record
Measured: Upon enrollment
Index clinic
Name of Federally Qualified Health Center clinic at which index encounter for spine pain occurred recorded in electronic health record
Measured: Upon enrollment
Spine pain region
Region of spine pain (neck, low back, both) recorded in electronic health record at index encounter
Measured: Upon enrollment
Spine pain acuity
New or existing spine pain problem recorded in electronic health record at index encounter
Measured: Upon enrollment
Patient comorbidity
Functional comorbidity index recorded in electronic health record
Measured: Upon enrollment
Patient existing prescriptions
Type and number of existing prescriptions recorded in electronic health record at index encounter
Measured: Upon enrollment
Patient new prescriptions
Type and number of new prescriptions recorded in electronic health record at index encounter
Measured: Upon enrollment
Patient referrals
Type and number of specialty referrals recorded in electronic health record at index encounter
Measured: Upon enrollment
Clinic size
Number of spine pain encounters during baseline period for each participating primary care clinic
Measured: Upon crossover to STEPPT
Clinic location
Geographic location of each participating primary care clinic
Measured: Upon crossover to STEPPT
Clinic PT Services
Availability of onsite physical therapy services for each participating primary care clinic
Measured: Upon crossover to STEPPT
Provider age
Ages of primary care providers employed at each participating clinic recorded in clinic operations records
Measured: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider sex
Sex of primary care providers employed at each participating clinic recorded in clinic operations records
Measured: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider race
Races of primary care providers employed at each participating clinic recorded in clinic operations records
Measured: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider ethnicity
Ethnicities of primary care providers employed at each participating clinic recorded in clinic operations records
Measured: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider education
Highest clinical degrees for primary care providers employed at participating clinics recorded in clinic operations records
Measured: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider specialty
Types of clinical specialties for primary care providers employed at each participating clinic recorded in clinic operations records
Measured: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider experience
Time elapsed between date of highest clinical degree for primary care providers at each participating clinic and date of index encounter
Measured: 6-, 12-, 18-, 24-, and 30-months after start of trial
Duration of provider employment
Duration of employment at federally qualified health center for primary care providers at each participating clinic recorded in clinical operations records
Measured: 6-, 12-, 18-, 24-, and 30-months after start of trial
PCP frequency of PT education
Primary care physician self-reported frequency of educating patients with spine pain about the benefits of physical therapy (never, rarely, sometimes, often, always)
Measured: Prior to training, 6-months after crossover to STEPPT
PCP qualitative interviews
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
Measured: 3-months after cross over to STEPPT
Allied provider frequency of PT education
Nurse and Medical Assistant self-reported frequency of educating patients about the benefits of physical therapy and referral process (never, rarely, sometimes, often, always)
Measured: Prior to training, 6-months after crossover to STEPPT
Allied provider qualitative interviews
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
Measured: 3-months after cross over to STEPPT
Training Involvement Rating Scale (IRS) score
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
Measured: 12-, 18-, 24--months after start of trial
ECN contact attempts
Proportion of Hispanic patients referred to PT with 0, 1, 2, 3, and ≥4 call attempts prior to scheduling first PT appointment or discontinuation due to failure-to-contact
Measured: 12-, 18-, 24-, and 30-months after start of trial
ECN completed contacts
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
Measured: 12-, 18-, 24-, and 30-months after start of trial
ECN delivery
Proportion of Hispanic patients who were successfully contacted for whom each mandatory component of enhanced care navigation was delivered
Measured: 12-, 18-, 24-, and 30-months after start of trial
Order Printed PT Education Materials
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
Measured: 12-, 18-, 24-, and 30-months after start of trial
Order Portal PT Education Materials
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
Measured: 12-, 18-, 24-, and 30-months after start of trial
Order Text PT Education Materials
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
Measured: 12-, 18-, 24-, and 30-months after start of trial
Patient Portal Views
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
Measured: 12-, 18-, 24-, and 30-months after start of trial
Patient Text Views
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
Measured: 12-, 18-, 24-, and 30-months after start of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 17,587 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Family Health Centers of San Diego
- Responsible party
- Principal investigator, Katrina Monroe, San Diego State University
- Investigators
- Katrina Monroe, PT, PhD, Principal investigator, San Diego State UniversitySara Gombatto, PT, PhD, Principal investigator, San Diego State University Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290361
- Sponsor's protocol ID
- HS-2023-0122
- Other IDs
- R01MD018937
- Acronym
- STEPPT
- Status last verified
- Feb 2026
- First submitted
- 14 Dec 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying published results will be shared via the Open Science Framework (OSF) repository, along with the study protocol, data dictionaries, statistical analysis plan, and intervention materials.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT): A Pragmatic Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT07290361
- Acronym / sponsor ID
- STEPPT / HS-2023-0122
- Conditions
- Low Back Pain, Neck Pain
- Keywords
- Physical therapy, Rehabilitation, Hispanic, Heatlh Services, Healthcare utilization, Federally Qualified Health Center
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17,587 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Family Health Centers of San Diego
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| STEPPT Care Pathway | Experimental | 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)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. |
| Usual Care Pathway (Control) | Active comparator | 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)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Usual Care Pathway (Control) |
| 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. | Behavioural | STEPPT Care Pathway |
| 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. | Behavioural | STEPPT Care Pathway |
| 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. | Behavioural | Usual Care Pathway (Control) |
| 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 | Behavioural | STEPPT Care Pathway |
| 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. | Behavioural | Usual Care Pathway (Control) |
| 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. | Behavioural | STEPPT Care Pathway |
| 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 | Behavioural | STEPPT Care Pathway |
| 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. | Behavioural | STEPPT Care Pathway |
| 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) | Behavioural | STEPPT Care Pathway |
| 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) | Behavioural | STEPPT Care Pathway |
| 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. | Behavioural | STEPPT Care Pathway |
| 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] | Behavioural | Usual Care Pathway (Control) |
| 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] | Behavioural | STEPPT Care Pathway |
| 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. | Behavioural | Usual Care Pathway (Control) |
| 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. | Behavioural | STEPPT Care Pathway |
| 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] | Behavioural | STEPPT Care Pathway |
| 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. | Behavioural | Usual Care Pathway (Control) |
| 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. | Behavioural | STEPPT Care Pathway |
| 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. | Behavioural | Usual Care Pathway (Control) |
| 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. | Behavioural | STEPPT Care Pathway |
| 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. | Behavioural | Usual Care Pathway (Control) |
Primary outcome
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.
47 secondary outcomes
Maintenance Physical Therapy Referral
Time frame: Patient level: 3-months after index PCP encounter; Clinic level: 30-months after start of trial
Maintenance Physical Therapy Adherence
Time frame: Patient level: 6-months after index physical therapy referral; Clinic level: 30-months after start of trial
Patient age
Time frame: Upon enrollment
Patient sex
Time frame: Upon enrollment
Patient race
Time frame: Upon enrollment
Patient ethnicity
Time frame: Upon enrollment
Patient birth place
Time frame: Upon enrollment
Patient education
Time frame: Upon enrollment
Patient employment
Time frame: Upon enrollment
Patient relationship status
Time frame: Upon enrollment
Patient neighborhood status
Time frame: Upon enrollment
Patient food insecurity
Time frame: Upon enrollment
Patient transportation status
Time frame: Upon enrollment
Patient insurance
Time frame: Upon enrollment
Patient language
Time frame: Upon enrollment
Patient interpreter
Time frame: Upon enrollment
Index clinic
Time frame: Upon enrollment
Spine pain region
Time frame: Upon enrollment
Spine pain acuity
Time frame: Upon enrollment
Patient comorbidity
Time frame: Upon enrollment
Patient existing prescriptions
Time frame: Upon enrollment
Patient new prescriptions
Time frame: Upon enrollment
Patient referrals
Time frame: Upon enrollment
Clinic size
Time frame: Upon crossover to STEPPT
Clinic location
Time frame: Upon crossover to STEPPT
Clinic PT Services
Time frame: Upon crossover to STEPPT
Provider age
Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider sex
Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider race
Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider ethnicity
Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider education
Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider specialty
Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial
Provider experience
Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial
Duration of provider employment
Time frame: 6-, 12-, 18-, 24-, and 30-months after start of trial
PCP frequency of PT education
Time frame: Prior to training, 6-months after crossover to STEPPT
PCP qualitative interviews
Time frame: 3-months after cross over to STEPPT
Allied provider frequency of PT education
Time frame: Prior to training, 6-months after crossover to STEPPT
Allied provider qualitative interviews
Time frame: 3-months after cross over to STEPPT
Training Involvement Rating Scale (IRS) score
Time frame: 12-, 18-, 24--months after start of trial
ECN contact attempts
Time frame: 12-, 18-, 24-, and 30-months after start of trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying published results will be shared via the Open Science Framework (OSF) repository, along with the study protocol, data dictionaries, statistical analysis plan, and intervention materials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katrina Monroe, PT, PhD principal investigator
San Diego State University
Sara Gombatto, PT, PhD principal investigator
San Diego State University Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engagement of clinic leadership (System Intervention - STEPPT), Patient Registry (System Intervention - STEPPT) and Delivery of Patient Education Materials (System Intervention - STEPPT) in people with Low Back Pain and Neck Pain, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheenee R Real, BSN, MPH, MSOL (323-508-6312, creal2@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.