STEPPT for Spine Pain

(STEPPT Trial)

Overseen By Shadia Assi, BS, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Non-musculoskeletal spine pain, Urgent intervention, Active PT referral, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

17587 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach, called STEPPT (Stratified Targeted Engagement from Primary Care to Physical Therapy), to improve access to and use of physical therapy for Hispanic patients with spine pain. The goal is to increase doctor referrals to physical therapy and patient attendance at sessions. Medical staff receive training, and patients receive culturally tailored information and scheduling assistance. Hispanic patients seeking care for neck or back pain at specific health centers may be eligible for the trial. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative strategies that could enhance healthcare access and outcomes.

What prior data suggests that the STEPPT intervention is safe for improving physical therapy referral and adherence rates?

Research has shown that the STEPPT Care Pathway uses a method called stratified care, which has been helpful in treating back pain in other studies. One study found that this method improved how doctors make treatment decisions, especially for patients at medium and high risk. Another study demonstrated that stratified care led to better outcomes for people with general low back pain.

Regarding safety, the STEPPT Care Pathway does not involve new medications or surgeries. It focuses on training doctors and providing educational materials to help patients. Since the approach emphasizes improving communication and support, no known safety risks exist. This makes it a well-tolerated option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STEPPT Care Pathway because it offers a unique, multi-level approach to managing spine pain among Hispanic patients. Unlike usual care, STEPPT focuses on providing culturally tailored patient education and enhanced care navigation with bilingual Patient Health Navigators. This intervention also includes provider training on guideline-based referrals and culturally responsive communication, aiming to improve adherence to physical therapy. These innovative features could lead to better patient engagement and outcomes by addressing cultural and systemic barriers that are often overlooked in standard spine pain treatments.

What evidence suggests that the STEPPT intervention is effective for improving physical therapy referral and adherence rates for Hispanic patients with spine pain?

Research has shown that a personalized care approach, such as the STEPPT Care Pathway, can greatly benefit individuals with back pain. One study found that implementing this approach in family doctor offices significantly improved patients' management of their disability and halved their time off work. Another study demonstrated its effectiveness in reducing disability related to low back pain. These findings suggest that STEPPT could enhance access to physical therapy for Hispanic patients with spine pain and encourage adherence to their treatment plans. ^{1 6 7 8 9}

Who Is on the Research Team?

Katrina Monroe, PT, PhD

Principal Investigator

San Diego State University

Sara Gombatto, PT, PhD

Principal Investigator

San Diego State University Research Foundation

Are You a Good Fit for This Trial?

This trial is for Hispanic patients with spine pain seeking care at a Federally Qualified Health Center serving low-income communities. It aims to see if the STEPPT system can improve referrals and adherence to physical therapy.

Inclusion Criteria

I have new or ongoing neck or back pain noted in my medical records.

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)

Exclusion Criteria

My back pain is not due to muscle or bone issues but another health condition.

I need urgent care for a serious medical issue like a fracture.

My physical therapy outside the FQHC won't count towards adherence.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Phase

Usual Care is provided to all clinics to establish baseline referral and adherence rates

6 months

Regular visits as per usual care

Intervention Phase

Implementation of STEPPT intervention to improve physical therapy referral and adherence

6 months per step

Regular visits with enhanced care navigation and education

Maintenance Phase

Continued monitoring of physical therapy referral and adherence rates post-intervention

3 months

Follow-up

Participants are monitored for long-term outcomes and effectiveness of the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Stratified Targeted Engagement from Primary Care to Physical Therapy (STEPPT)

Trial Overview

STEPPT, an intervention that includes provider training, patient education on spine pain and physical therapy benefits, culturally tailored materials, assistance in scheduling appointments, and monitoring of adherence rates.

How Is the Trial Designed?

Group I: STEPPT Care Pathway Experimental Treatment 15 Interventions

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.

Group II: Usual Care Pathway (Control) Active Control 7 Interventions

The Usual Care Arm involves a medical evaluation by a primary care provider who may prescribe any combination of self-management advice, patient education, medication, physical therapy, chiropractic, or specialist care at the provider's discretion. If referred to physical therapy, a centralized Referral Specialist verifies insurance and attempts to schedule the evaluation. No culturally tailored education, enhanced navigation, or provider/staff training is provided beyond the current standard of care.

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Family Health Centers of San Diego

Collaborator

Trials

9

Recruited

15,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07290361

Stratified Targeted Engagement From Primary Care to ...

This study will examine the implementation and effectiveness of STEPPT for improving access and engagement of Hispanic patients with spine pain ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3948756/

Effect of Stratified Care for Low Back Pain in Family ...

Stratified care for back pain implemented in family practice leads to significant improvements in patient disability outcomes and a halving in time off work, ...

3.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00075-4/fulltext

Stratified care to prevent chronic low back pain in high-risk ...

There were no differences detected in transition to chronic LBP among patients presenting with acute LBP using a stratified approach to care.

4.

annfammed.org

annfammed.org/content/annalsfm/22/3/195.full.pdf

A Stratified Approach for Managing Patients With Low Back ...

PURPOSE To determine the effects of stratified primary care for low back pain (SPLIT pro- gram) in decreasing back-related disability for patients with low back ...

5.

academic.oup.com

academic.oup.com/ptj/article/97/3/330/2998989

Outcomes of Patients With Acute Low Back Pain Stratified by ...

More than a quarter of patients who consult a primary care provider for acute low back pain (LBP) will continue to have pain and disability at 2 years,1 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6095099/

Advancing practice for back pain through stratified care (STarT ...

The study demonstrated that stratified care changed clinician treatment decisions for the better, with greater proportions of patients at medium and high risk ...

7.

academic.oup.com

academic.oup.com/ptj/article/95/8/1120/2686460

Pragmatic Implementation of a Stratified Primary Care Model ...

The purposes of this study were: (1) to assess implementation of a stratified care approach for LBP management by evaluating short-term treatment effects.

8.

researchgate.net

researchgate.net/publication/350523842_Stratified_care_to_prevent_chronic_low_back_pain_in_high-risk_patients_The_TARGET_trial_A_multi-site_pragmatic_cluster_randomized_trial

Stratified care to prevent chronic low back pain in high-risk ...

... A meta-analysis reported very low-certainty evidence that stratified care has a small effect on pain reduction at 3 and 6 months, with no impact on ...

9.

thelancet.com

thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)30099-0/fulltext

Stratified care versus usual care for management of ...

Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to ...