PainSTEPPT PILOTNCT06835439

Development of STEPPT

A study testing STEPPT Pilot in people with Pain and Back Pain, run by San Diego State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Back Pain, Low Back Pain
What is being tested?: STEPPT Pilot
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteUnited States
Study dates: 2 Nov 2024to 2 Dec 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age: 18 years or older.
Patients seeking care within the designated Federally Qualified Health System Adult or Adult Walk-in primary care clinic
Ethnicity/Race: Participants must identify as either Hispanic or Non-Hispanic White ethnicity/race.
Consent: Participants must have signed a broad consent for the use of de-identified health information for research.
Spine Pain: Participants must meet one of the following:
New Spine Pain Problem: A new ICD code for neck or back pain added to the problem list during a visit with a primary care physician.
Existing Spine Pain Diagnosis: 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.

Who cannot join

Non-Musculoskeletal Spine Pain: Participants with spine pain due to a non-musculoskeletal etiology (e.g., infection, cancer, urological disorders, pregnancy) are excluded.
Urgent Medical Conditions: Patients requiring urgent medical intervention (e.g., fracture, cauda equina syndrome) are excluded.
Patients with a physical therapy referral external to the healthcare system are excluded from the analysis of physical therapy adherence

Trial locations and contacts

1 site in 1 country.

United States1 site

Family Health Centers of San Diego
San Diego, California, 92102

Other trials in United States

About this study

Official title: Improving Access and Engagement in Spine Pain Rehabilitation - STEPPT Mixed Methods Pilot Study

This 6-month pilot study aims to assess the feasibility, acceptability, and estimate effect sizes of the pilot STEPPT intervention for addressing ethnic disparities in physical therapy referrals and adherence between Hispanic and Non-Hispanic White patients with spine pain. Feasibility and acceptability will be assessed based on the extent to which the pilot clinic implements all components of the intervention appropriately, feedback from clinic staff during implementation of the intervention, and feedback from patients during post-intervention interviews. The investigators anticipate that the intervention will be both feasible and acceptable. Feedback from patients and clinic staff will be used to inform intervention modifications for a larger clinical trial. Effect sizes for the pilot STEPPT intervention (intervention) in comparison to standard care (control) will be assessed by evaluating changes in ethnic disparities (Hispanic vs. Non-Hispanic White) in physician referral to physical therapy and patient adherence to physical therapy referral for the treatment of spine pain before and after implementation of the pilot STEPPT intervention. In comparison to standard care, the investigators expect STEPPT to reduce ethnic disparities in referral and adherence outcomes.

Read the detailed description

STEPPT is a health system, quality improvement intervention for Hispanic patients with spine pain including the following components: (1) education of providers and staff on disparities in referrals and the benefits of physical therapy for spine pain, (2) modifications to the EHR to automate physical therapy referral and delivery of culturally tailored patient education materials, and (3) enhanced patient health navigation to educate patients and address barriers to attending physical therapy for Hispanic patients with spine pain. This pilot study aims to test the feasibility and acceptability of a prototype intervention developed using patient feedback, focus groups, and collaboration with Family Health Centers of San Diego (FHCSD) administrators and staff. The primary outcome is change in relative rates of referral and adherence to physical therapy between Hispanic and Non-Hispanic White patients with spine pain before and after implementation of the STEPPT intervention within one pilot clinic in the health system. The study will collect data on physical therapy referrals and adherence from electronic health records (EHR) before (3-month usual care control phase) and after (3-month intervention phase) implementing STEPPT. A process evaluation will be conducted through monthly audits and structured observations of clinic workflow. Ongoing interactions with clinic staff will facilitate implementation of the intervention and solicit suggestions for improving feasibility. Post-intervention interviews with a subset of Hispanic patients will assess acceptability of the intervention. Interviews will focus on patient experiences with education materials and enhanced healthcare navigation

Conditions: Pain, Back Pain, Low Back Pain, Chronic Pain, Neck Pain
Being tested: STEPPT Pilot, Standard Care (Control)
Keywords: Physical therapy, Rehabilitation, Hispanic, Health disparities, Health services, Healthcare utilization
Medical subject headings: Pain, Back Pain, Low Back Pain, Chronic Pain, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

STEPPT PilotBehavioural
The pilot STEPPT intervention, which includes (1) education of providers and staff on disparities in referrals and the benefits of physical therapy for spine pain, (2) modifications to the EHR to automate physical therapy referral and delivery of culturally tailored patient education materials related to the physical therapy referral, and (3) enhanced patient health navigation to educate patients on physical therapy and address barriers to attending physical therapy for Hispanic patients with spine pain. Patient education materials were developed using evidence-based guidelines and were culturally and linguistically adapted for Hispanic patients with spine pain.
Standard Care (Control)Behavioural
Usual care (3-month baseline) includes no provider education, physician-initiated referrals and delivery of standard educational materials, and scheduling for physical therapy by the clinic referrals specialists using standard processes.

Study groups in NCT06835439
Study group	Role	What they receive
STEPPT Intervention	Experimental	Participants in this arm will receive the pilot STEPPT intervention, which includes (1) education of providers and staff on disparities in referrals and the benefits of physical therapy for spine pain, (2) modifications to the EHR to automate physical therapy referral and delivery of culturally tailored patient education materials, and (3) enhanced patient health navigation to educate patients and address barriers to attending physical therapy for Hispanic patients with spine pain. The goal is to reduce ethnic disparities by improving physical therapy referral and adherence rates for Hispanic patients with spine pain. Receives: Behavioral: STEPPT Pilot
Standard Care (Control)	Active comparator	Standard care during the 3-month baseline period, prior to implementing the STEPPT intervention, will be the active comparator arm. Ethnic disparities in referral and adherence rates will be compared between the 3-month baseline period and the 3-month intervention period to estimate the effect size of the pilot STEPPT intervention for reducing ethnic disparities in physical therapy referral and adherence outcomes. Receives: Behavioral: Standard Care (Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

Ethnic Disparity in Rate of Physician Referral to Physical Therapy
Ethnic disparity (Hispanic vs. Non-Hispanic White) in rate of physician referral of patients with spine pain (low back or neck pain) to physical therapy, as documented in the electronic health record (EHR).
Measured: 3-month before the intervention and 3 month during intervention period.
Ethnic Disparity in Rate of Patient Adherence to Physical Therapy Referral
Ethnic disparity (Hispanic vs. Non-Hispanic White) in rate of attendance of first physical therapy visit after being referred, as documented in the electronic health record (EHR).
Measured: 3-month before the intervention and 3 month during intervention period.

Secondary outcomes (2)

Involvement Rating Score
This outcome is a clinic-level composite implementation score assessed once for a single clinic. Because only one clinic was evaluated, a measure of dispersion cannot be calculated, and the reported value reflects the single observed score. The total score ranges from 0 to 11 points and is categorized as unsatisfactory (0-3), moderate (4-7), and satisfactory (8-11) involvement of FHCSD providers and staff in STEPPT training. The score is composed of five components: Provider Orientation (0-3), Audit and Feedback (0-2), Enhanced Care Navigation Outreach (0-2), Enhanced Care Navigation Delivery (0-2), and Video Views (0-2).
Measured: 3-month pilot intervention period.
Patient Interviews
Qualitative interviews to assess acceptability and potential impact of the STEPPT intervention on Hispanic patients with spine pain.
Measured: Up to 3-months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 20242 Dec 2025

First posted19 Feb 2025
Study start2 Nov 2024
Primary completion30 Apr 2025
Study completion2 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Sequential
Model description: The primary purpose of this pilot study is to assess the feasibility, acceptability, and estimate effect size of the pilot STEPPT intervention for improving ethnic disparities in physical therapy referral and adherence between Hispanic and Non-Hispanic White patients with spine pain. The health services intervention design is a single site, mixed-methods pilot study using a non-randomized quasi-experimental pre-post design.
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06835439
Sponsor's protocol ID: IRB-24-0391
Other IDs: R01MD018937
Acronym: STEPPT PILOT
Status last verified: May 2026
First submitted: 5 Feb 2025
Last updated: 11 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: An IPD sharing plan will be developed for a subsequent stepped wedge clinical trial to assess effectiveness of the final STEPPT intervention. Limited collection of IPD during the developmental phase of this project will not be shared due to time and resource constraints.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Access and Engagement in Spine Pain Rehabilitation - STEPPT Mixed Methods Pilot Study
ClinicalTrials.gov ID: NCT06835439
Acronym / sponsor ID: STEPPT PILOT / IRB-24-0391
Conditions: Pain, Back Pain, Low Back Pain, Chronic Pain, Neck Pain
Keywords: Physical therapy, Rehabilitation, Hispanic, Health disparities, Health services, Healthcare utilization
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
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: 2 Nov 2024 (actual)
Primary completion: 30 Apr 2025 (actual)
Study completion: 2 Dec 2025 (actual)
First posted: 19 Feb 2025 (actual)
Results: Posted 11 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: The primary purpose of this pilot study is to assess the feasibility, acceptability, and estimate effect size of the pilot STEPPT intervention for improving ethnic disparities in physical therapy referral and adherence between Hispanic and Non-Hispanic White patients with spine pain. The health services intervention design is a single site, mixed-methods pilot study using a non-randomized quasi-experimental pre-post design.

Arm	Type	Receives
STEPPT Intervention	Experimental	Behavioral: STEPPT PilotParticipants in this arm will receive the pilot STEPPT intervention, which includes (1) education of providers and staff on disparities in referrals and the benefits of physical therapy for spine pain, (2) modifications to the EHR to automate physical therapy referral and delivery of culturally tailored patient education materials, and (3) enhanced patient health navigation to educate patients and address barriers to attending physical therapy for Hispanic patients with spine pain. The goal is to reduce ethnic disparities by improving physical therapy referral and adherence rates for Hispanic patients with spine pain.
Standard Care (Control)	Active comparator	Behavioral: Standard Care (Control)Standard care during the 3-month baseline period, prior to implementing the STEPPT intervention, will be the active comparator arm. Ethnic disparities in referral and adherence rates will be compared between the 3-month baseline period and the 3-month intervention period to estimate the effect size of the pilot STEPPT intervention for reducing ethnic disparities in physical therapy referral and adherence outcomes.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age: 18 years or older.
Patients seeking care within the designated Federally Qualified Health System Adult or Adult Walk-in primary care clinic
Ethnicity/Race: Participants must identify as either Hispanic or Non-Hispanic White ethnicity/race.
Consent: Participants must have signed a broad consent for the use of de-identified health information for research.
Spine Pain: Participants must meet one of the following:

Key exclusion criteria (3 listed)

Non-Musculoskeletal Spine Pain: Participants with spine pain due to a non-musculoskeletal etiology (e.g., infection, cancer, urological disorders, pregnancy) are excluded.
Urgent Medical Conditions: Patients requiring urgent medical intervention (e.g., fracture, cauda equina syndrome) are excluded.
Patients with a physical therapy referral external to the healthcare system are 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
STEPPT PilotThe pilot STEPPT intervention, which includes (1) education of providers and staff on disparities in referrals and the benefits of physical therapy for spine pain, (2) modifications to the EHR to automate physical therapy referral and delivery of culturally tailored patient education materials related to the physical therapy referral, and (3) enhanced patient health navigation to educate patients on physical therapy and address barriers to attending physical therapy for Hispanic patients with spine pain. Patient education materials were developed using evidence-based guidelines and were culturally and linguistically adapted for Hispanic patients with spine pain.	Behavioural	STEPPT Intervention
Standard Care (Control)Usual care (3-month baseline) includes no provider education, physician-initiated referrals and delivery of standard educational materials, and scheduling for physical therapy by the clinic referrals specialists using standard processes.	Behavioural	Standard Care (Control)

Primary outcome

Ethnic Disparity in Rate of Physician Referral to Physical Therapy
Time frame: 3-month before the intervention and 3 month during intervention period.
Ethnic disparity (Hispanic vs. Non-Hispanic White) in rate of physician referral of patients with spine pain (low back or neck pain) to physical therapy, as documented in the electronic health record (EHR).
Ethnic Disparity in Rate of Patient Adherence to Physical Therapy Referral
Time frame: 3-month before the intervention and 3 month during intervention period.
Ethnic disparity (Hispanic vs. Non-Hispanic White) in rate of attendance of first physical therapy visit after being referred, as documented in the electronic health record (EHR).

2 secondary outcomes

Involvement Rating Score
Time frame: 3-month pilot intervention period.
Patient Interviews
Time frame: Up to 3-months post-intervention

Results and safety

Results posted to the registry on 11 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Care (Control)	59	12
STEPPT Intervention	85	26

Primary outcome: Ethnic Disparity in Rate of Physician Referral to Physical Therapy

Time frame: 3-month before the intervention and 3 month during intervention period.. Count of participants. Unit: Participants

Measure	Standard Care (Control) n = 59	STEPPT Intervention n = 80
Hispanic	13	30
Non-Hispanic White	13	22

Population analysed: The analysis population includes all participants (N=139), excluding participants who were withdrawn (N=5). Outcome values reflect the proportion of enrolled participants referred to physical therapy, stratified by ethnicity. Participants were categorized by ethnicity to assess differences in referral.

Primary outcome: Ethnic Disparity in Rate of Patient Adherence to Physical Therapy Referral

Time frame: 3-month before the intervention and 3 month during intervention period.. Count of participants. Unit: Participants

Measure	Standard Care (Control) n = 26	STEPPT Intervention n = 52
Hispanic	5	16
Non-Hispanic White	7	10

Population analysed: The analysis population includes only participants referred to physical therapy (N=78). The outcome values represent adherence status among those referred. Participants enrolled in the study but not referred to physical therapy were not eligible for this outcome and are not included, explaining the difference from Participant Flow.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until PT adherence assessment, up to 9 months after enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
STEPPT Intervention	0 of 85 (0%)	0 of 85 (0%)	0 of 85
Standard Care (Control)	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. An IPD sharing plan will be developed for a subsequent stepped wedge clinical trial to assess effectiveness of the final STEPPT intervention. Limited collection of IPD during the developmental phase of this project will not be shared due to time and resource constraints.

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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. This study is not recruiting at the moment.

Katrina Monroe, PT, PhD principal investigator

San Diego State University

Sara Gombatto, PT, PhD principal investigator

San Diego State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing STEPPT Pilot in people with Pain and Back 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 11 May 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?

Yes. Results are posted in the registry (first posted 11 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ethnic Disparity in Rate of Physician Referral to Physical Therapy (time frame: 3-month before the intervention and 3 month during intervention period.). 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?

On the ClinicalTrials.gov record for NCT06835439.

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 11 May 2026.