Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-30 @ 4:04 AM
Study NCT ID:
NCT07290361
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)
Sponsor:
San Diego State University
Organization:
Study Overview
Official Title:
Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT): A Pragmatic Stepped Wedge Cluster Randomized Trial
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPPT
Brief 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 heterogeneity between steps, allocation of clinics will be balanced with respect to key characteristics, including clinic size (number of unique patient encounters for spine pain per month) and historical rates of physical therapy (PT) referral and adherence in the year prior to allocation. The nine clinics will first be stratified into three strata using simulation to identify the allocation that minimizes imbalance across steps. Within each stratum, clinics will then be randomly assigned to one of three sequential cross-over start dates, such that each step includes one clinic from each stratum. The three steps will transition from Usual Care (control) to STEPPT (intervention) at 6-month intervals. A 6-month period of Usual Care for all clinics will precede the first date of cross over into STEPPT.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01MD018937 | NIH | None | https://reporter.nih.gov/quic… | View |