Trial Outcomes & Findings for Development of STEPPT (NCT NCT06835439)
NCT ID: NCT06835439
Last Updated: 2026-05-11
Results Overview
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).
COMPLETED
NA
144 participants
3-month before the intervention and 3 month during intervention period.
2026-05-11
Participant Flow
The study took place at an FHCSD primary care clinic. All patients meeting the inclusion criteria were enrolled in outcome tracking via the Electronic Health Record, as this was a quality-improvement intervention. A purposive sample of Hispanic participants were invited by a research assistant to participate in qualitative interviews conducted in person or via Zoom.
Five participants no longer met the inclusion criteria before exposure to the intervention and were withdrawn.
Participant milestones
| Measure |
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.
|
STEPPT Intervention
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.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
85
|
|
Overall Study
PT Referral
|
26
|
52
|
|
Overall Study
COMPLETED
|
12
|
26
|
|
Overall Study
NOT COMPLETED
|
47
|
59
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of STEPPT
Baseline characteristics by cohort
| Measure |
Standard Care (Control)
n=59 Participants
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.
|
STEPPT Intervention
n=85 Participants
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.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=44 Participants
|
75 Participants
n=10 Participants
|
130 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=44 Participants
|
10 Participants
n=10 Participants
|
14 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=44 Participants
|
62 Participants
n=10 Participants
|
98 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=44 Participants
|
23 Participants
n=10 Participants
|
46 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
33 Participants
n=44 Participants
|
50 Participants
n=10 Participants
|
83 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
26 Participants
n=44 Participants
|
35 Participants
n=10 Participants
|
61 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 3-month before the intervention and 3 month during intervention period.Population: 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.
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).
Outcome measures
| Measure |
Standard Care (Control)
n=59 Participants
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.
|
STEPPT Intervention
n=80 Participants
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.
|
|---|---|---|
|
Ethnic Disparity in Rate of Physician Referral to Physical Therapy
Hispanic
|
13 Participants
|
30 Participants
|
|
Ethnic Disparity in Rate of Physician Referral to Physical Therapy
Non-Hispanic White
|
13 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 3-month before the intervention and 3 month during intervention period.Population: 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.
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).
Outcome measures
| Measure |
Standard Care (Control)
n=26 Participants
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.
|
STEPPT Intervention
n=52 Participants
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.
|
|---|---|---|
|
Ethnic Disparity in Rate of Patient Adherence to Physical Therapy Referral
Hispanic
|
5 Participants
|
16 Participants
|
|
Ethnic Disparity in Rate of Patient Adherence to Physical Therapy Referral
Non-Hispanic White
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3-month pilot intervention period.Population: Number of units analyzed (N=1) indicates the 1 clinic that participated in the pilot study and completed the Involvement Rating Score. The Involvement Rating Score was not assessed during the baseline period and was measured only during the implementation phase of the study.
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).
Outcome measures
| Measure |
Standard Care (Control)
n=1 Clinic
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.
|
STEPPT Intervention
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.
|
|---|---|---|
|
Involvement Rating Score
|
8 Score
Interval 8.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Up to 3-months post-interventionPopulation: The analysis population includes participants in the STEPPT intervention arm who completed a patient interview (N=12). Participants could contribute to more than one theme if multiple themes were mentioned; therefore, counts across rows may exceed the total number analyzed.
Qualitative interviews to assess acceptability and potential impact of the STEPPT intervention on Hispanic patients with spine pain.
Outcome measures
| Measure |
Standard Care (Control)
n=12 Participants
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.
|
STEPPT Intervention
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.
|
|---|---|---|
|
Patient Interviews
Number of patients who received/recalled at least 1 education material
|
6 Participants
|
—
|
|
Patient Interviews
Materials informative but less influential in decisions to attend PT than provider recommendations
|
11 Participants
|
—
|
|
Patient Interviews
Education materials increased understanding of pain, treatment options, and PT
|
5 Participants
|
—
|
|
Patient Interviews
Participants engaged with materials via hardcopy, text messages, and videos
|
5 Participants
|
—
|
|
Patient Interviews
Participants valued different material components: pain education, PT referral info, exercises
|
5 Participants
|
—
|
|
Patient Interviews
Participants shared education materials with close social networks
|
3 Participants
|
—
|
|
Patient Interviews
Clinic providers and staff gave limited explanation of education materials
|
12 Participants
|
—
|
|
Patient Interviews
Education materials and enhanced care navigation should be a standard part of care
|
11 Participants
|
—
|
|
Patient Interviews
Number of patients who received/recalled Enhanced Care Navigation
|
8 Participants
|
—
|
|
Patient Interviews
Enhanced Care Navigation reinforced and supported PT attendance, through scheduling
|
8 Participants
|
—
|
|
Patient Interviews
Patients wanted more support from navigator: empathic communication, more explanation of pain and PT
|
6 Participants
|
—
|
Adverse Events
STEPPT Intervention
Standard Care (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Katrina Monroe, PT, PhD
San Diego State University Research Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place