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NCT07290361NARecruiting

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

San Diego State University

Start Date

12/1/2025

Completion Date

2/28/2029

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 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Engagement of clinic leadership (System Intervention - Usual Care)

BEHAVIORAL

Engagement of clinic leadership (System Intervention - STEPPT)

BEHAVIORAL

Patient Registry (System Intervention - STEPPT)

BEHAVIORAL

Delivery of Patient Education Materials (System Intervention - Usual Care)

BEHAVIORAL

Delivery of Patient Education Materials (System Intervention - STEPPT)

BEHAVIORAL

Referral Specialist Training (System Intervention - Usual Care)

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 - Usual Care)

BEHAVIORAL

Patient education on spine pain condition (Patient Intervention - STEPPT)

BEHAVIORAL

Patient Education on Physical Referral by Providers (Patient Intervention - Usual Care)

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 Referral Specialist (Patient Intervention - Usual Care)

BEHAVIORAL

Patient education on physical therapy referral by Patient Health Navigator (Patient Intervention - STEPPT)

BEHAVIORAL

Care Navigation (System Intervention - Usual Care)

BEHAVIORAL

Monitoring of PT referral and adherence rates (System Intervention - STEPPT)

BEHAVIORAL

Monitoring of PT referral and adherence rates (System intervention - Usual Care)

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Conditions

Low Back PainNeck Pain

Locations

Family Health Centers of San Diego

San Diego, California 92182

United States