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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD018937 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Family Health Centers of San Diego | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STEPPT Pilot | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 3-month before the intervention and 3 month during intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrina Monroe, PT, PhD | San Diego State University | Principal Investigator |
| Sara Gombatto, PT, PhD | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Health Centers of San Diego | San Diego | California | 92102 | United States |
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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Five participants no longer met the inclusion criteria before exposure to the intervention and were withdrawn.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline analysis population consists of all patients who received the pilot intervention during routine care at the FHCSD clinic and had baseline demographic or clinical data available in the health record.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Count of Participants | Participants | 3-month before the intervention and 3 month during intervention period. |
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From enrollment until PT adherence assessment, up to 9 months after enrollment.
This was a quality improvement and implementation study. Adverse events were not anticipated and were not systematically monitored as part of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katrina Monroe, PT, PhD | San Diego State University Research Foundation | 303-726-7932 | ksmonroe@sdsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2025 | Apr 14, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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.
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| Standard Care (Control) | Behavioral | 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. |
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| 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. | Up to 3-months post-intervention |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | 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. |
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| Primary | 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). | 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. | Posted | Count of Participants | Participants | 3-month before the intervention and 3 month during intervention period. |
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| Secondary | 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). | 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. | Posted | Number | Score | 3-month pilot intervention period. | Clinic | Clinic |
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| Secondary | Patient Interviews | Qualitative interviews to assess acceptability and potential impact of the STEPPT intervention on Hispanic patients with spine pain. | 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. | Posted | Count of Participants | Participants | No | Up to 3-months post-intervention |
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|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | 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. | 0 | 59 | 0 | 59 | 0 | 59 |
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| Non-Hispanic White |
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| Participants engaged with materials via hardcopy, text messages, and videos |
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| Participants valued different material components: pain education, PT referral info, exercises |
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| Participants shared education materials with close social networks |
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| Clinic providers and staff gave limited explanation of education materials |
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| Education materials and enhanced care navigation should be a standard part of care |
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| Number of patients who received/recalled Enhanced Care Navigation |
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| Enhanced Care Navigation reinforced and supported PT attendance, through scheduling |
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| Patients wanted more support from navigator: empathic communication, more explanation of pain and PT |
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