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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention 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.
Primary Purpose
Health Services Research
Masking
None (Open Label)
Masking Description
The STEPPT trial will use single blind masking in which patients will remain blind to the study purpose and alternate care pathways (STEPPT Care vs. Usual Care) throughout the trial. Providers and clinic staff cannot be blinded due to the nature of the intervention (i.e., providers and staff require training to administer STEPPT and implement workflow changes). The order of cross-over from Usual Care to STEPPT will be concealed from investigators, providers, and staff until one month prior to each step in the SW-CRT. At this time, the statistician will communicate the clinics that have been randomly assigned to cross over to the FQHC Research Manager who will then initiate training activities which will unblind providers and staff. Primary and secondary outcomes will be assessed using automated algorithms applied to electronic health record (EHR) data to minimize bias. Investigators, providers, and staff will have access to these data for feedback and quality improvement purposes.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Behavioral: Engagement of clinic leadership (System Intervention - STEPPT)
    Clinic Directors and Charge Nurses engage in STEPPT onboarding meeting with STEPPT Project Manager to discuss STEPPT objectives, procedures, and need for local adaptations. Medical leaders champion provider training and facilitate change in practice patterns through regularly scheduled review of trends in PT referral and adherence patterns with STEPPT Project Manager.
  • Behavioral: Patient Registry (System Intervention - STEPPT)
    Patients referred to physical therapy for spine pain are stratified by ethnicity. Hispanic patients are added to STEPPT Patient Registry to facilitate targeted engagement of an underserved population known to have low rates of adherence for physical therapy referrals.
  • Behavioral: Delivery of Patient Education Materials (System Intervention - STEPPT)
    Automated delivery systems for patient education materials include: - Auto-order for culturally tailored neck or back pain fact sheet, general PT fact sheet, and postural exercise fact sheet printed in the AVS for all Hispanic patients with a new or existing spine pain problem - Auto-order for text message with links to culturally tailored PT referral fact sheet and video upon referral to PT for spine pain - Auto-order for culturally tailored neck or back pain fact sheet, general PT fact sheet, postural exercise fact sheet, PT referral fact sheet, and video added to the patient portal upon referral to PT for spine pain
  • Behavioral: Patient Health Navigator Training (System Intervention - STEPPT)
    Patient Health Navigators (PHNs) trained in system-wide procedures for processing referrals, calling patients, and scheduling appointments for specialty services. Additional training on patient communication and enhanced care navigation is provided to address cultural factors, individual barriers, and risk factors for non-adherence. Physical therapy referrals processed by a specially trained team of Physical Rehabilitation Services PHNs.
  • Behavioral: Care Navigation (System Intervention - STEPPT)
    Upon referral to PT and verification of insurance coverage, patients receive a system-generated auto-call to schedule the PT evaluation followed by up to 3 phone contact attempts by a Patient Health Navigator (PHN) to 1) deliver enhanced care navigation, and 2) schedule PT evaluation. Prior to scheduling, PHN delivers semi-scripted enhanced care navigation (ECN) with mandatory components: - Summarize benefits of PT - Emphasize importance of attending PT even if prescribed medication for temporary pain relief - Confirm patient received and reviewed educational materials. Resend materials, if needed - Address privacy concerns, if present - Address risk factors for PT non-adherence, if present: scheduling, cost, transportation barriers - Address other questions or concerns - Schedule the PT evaluation - Repeat appointment details and provide PHN contact information for additional questions
  • Behavioral: Care navigation audit and feedback (System Intervention - STEPPT)
    Audits of fidelity to enhanced care navigation protocol using self-report checklists and review of recorded phone calls are discussed monthly with PHNs to facilitate competent and consistent delivery of enhanced care navigation for patients in STEPPT registry.
  • Behavioral: Primary Care Provider training (Provider Intervention - STEPPT)
    PCPs attend training with Physical Rehabilitation Services site manager on the following topics: - STEPPT objectives, procedures, and patient education materials - Referral and adherence rates for PT among Hispanic patients at FQHC clinics - Benefits of PT referral for patients with new and existing spine pain problems - Culturally responsive strategies to improve patient engagement in PT services (e.g., explanation of how PT can improve family and social role functioning)
  • Behavioral: Nurse/Medical Assistant Training (Provider Intervention - STEPPT)
    Nurses and MAs attend training with Physical Rehabilitation Services site manager on the following topics: - STEPPT objectives, procedures, and patient education materials - Referral and adherence rates for PT among Hispanic patients at FQHC clinics - Benefits of PT referral for patients with new and existing spine pain problems - Culturally responsive strategies to improve patient engagement in PT services (e.g., explanation of the FQHC referral process)
  • Behavioral: Provider feedback on PT referral and adherence (Provider Intervention - STEPPT)
    Trends in PT referral and adherence rates, stratified by ethnicity, are reviewed biannually at "Provider Huddles" along with suggestions for improvement as needed.
  • Behavioral: Patient education on spine pain condition (Patient Intervention - STEPPT)
    Verbal patient education on etiology, treatment, and prognosis for spine pain may be provided at the discretion of Primary Care Physician. Patient education materials auto-ordered in the printed After Visit Summary for all patients with a new or existing spine pain problem on the electronic health record Problem List. STEPPT patient education materials include: (1) Back Pain or Neck Pain Facts, a culturally tailored factsheet summarizing current evidence on etiology, prognosis, and treatment (medical and self-management) for back or neck pain, (2) Physical Therapy Fact Sheet, culturally tailored information describing physical therapy evaluation and treatment options for pain with a QR code linking to a Physical Therapy Education Video, (3) Posture Exercises, culturally tailored instructions for standing posture, seated posture, and supine diaphragmatic breathing. [All patient education materials available in English or Spanish language]
  • Behavioral: Patient Education on Physical Referral by Providers (Patient Intervention - STEPPT)
    Following training in best practices, primary care providers encouraged to provide culturally responsive patient education on benefits of PT for spine pain at index encounter. Nurses and medical assistants encouraged to review printed patient education materials on benefits of PT and institutional referral process. Patients are notified of referral for physical therapy consultation in the printed After Visit Summary at index encounter.
  • Behavioral: Electronic Patient Education on Physical Therapy Referral (Patient Intervention - STEPPT)
    Patient receives auto-email from patient portal and auto-text message with links to electronic patient education materials upon being referred to PT: - Physical Therapy Referral Information - Culturally tailored information highlighting the importance of attending PT, resources to support regular attendance, and instructions for scheduling and preparing for the PT evaluation. [Eng/Span] - Physical Therapy Education Video - Culturally tailored video showing how to schedule and attend the PT evaluation with testimonials from former FQHC patients highlighting benefits of PT for spine pain. [Eng/Span]
  • Behavioral: Patient education on physical therapy referral by Patient Health Navigator (Patient Intervention - STEPPT)
    Culturally responsive, semi-scripted patient education on benefits of physical therapy and logistics of physical therapy appointments provided verbally by a Patient Health Navigator (PHN) when scheduling the physical therapy consultation. PHN identifies and helps mitigate individual barriers for attending physical therapy appointments.
  • Behavioral: 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.
Active Comparator
Usual Care Pathway (Control) 		The Usual Care Arm involves the current institutional standard of referral and scheduling processes. If a patient is referred to physical therapy, a centralized Referral Specialist verifies insurance and attempts to schedule the evaluation. No provider/staff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.
  • Behavioral: Engagement of clinic leadership (System Intervention - Usual Care)
    No engagement of clinic leadership in promotion or monitoring of PT referral patterns among providers or PT adherence patterns among patients
  • Behavioral: Delivery of Patient Education Materials (System Intervention - Usual Care)
    Neck or back pain fact sheet may be manually ordered in the printed after visit summary at the discretion of the primary care physician. No automated systems for delivery of patient education materials on spine pain or physical therapy referral.
  • Behavioral: Referral Specialist Training (System Intervention - Usual Care)
    Referral Specialists trained in system-wide procedures for processing referrals, calling patients, and scheduling appointments for specialty services. Physical therapy referrals processed by a dedicated team of Physical Rehabilitation Services Referral Specialists.
  • Behavioral: Patient education on spine pain condition (Patient Intervention - Usual Care)
    Verbal patient education on etiology, treatment, and prognosis for spine pain may be provided at the discretion of Primary Care Physician. Back Pain or Neck Pain Fact Sheet may be ordered in the printed After Visit Summary at the discretion of Primary Care Physician. Back Pain/Neck Pain Factsheet summarizes current evidence on etiology, prognosis, and treatment (medical and self-management) for back or neck pain. [Available in English or Spanish language]
  • Behavioral: Patient Education on Physical Referral by Providers (Patient Intervention - Usual Care)
    Verbal patient education on physical therapy referral may be provided at the discretion of Primary Care Physician, Nurse, and/or Medical Assistant at index encounter. Patients are notified of referral for physical therapy consultation in the printed After Visit Summary. No written instructions on physical therapy referral process are provided.
  • Behavioral: Patient education on physical therapy referral by Referral Specialist (Patient Intervention - Usual Care)
    Verbal patient education on physical therapy referral may be provided at the discretion of the Referral Specialist when scheduling the physical therapy consultation.
  • Behavioral: Care Navigation (System Intervention - Usual Care)
    Upon PT referral and verification of insurance coverage, patient receives up to 2 system-generated auto-calls to schedule PT evaluation. If no contact is made after 30 days, a system-generated letter is sent by mail requesting the patient call a centralized Referral Specialist to schedule the PT evaluation. Additional care navigation services may be provided at the discretion of the Referral Specialist.
  • Behavioral: Monitoring of PT referral and adherence rates (System intervention - Usual Care)
    PT referral and adherence rates monitored as needed by Vice President of Specialty Services.

Recruiting Locations

Family Health Centers of San Diego
San Diego 5391811, California 5332921 92182
Contact:
Job Godino, PhD
619-515-2344
jobg@fhcsd.org

More Details

Status
Recruiting
Sponsor
San Diego State University

Study Contact

Cheenee R Real, BSN, MPH, MSOL
323-508-6312
creal2@sdsu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.