[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615265":3},{"organization":4,"outcomesModule":7,"designInfo":169,"detailedDescription":177,"studyPopulation":168,"armGroups":178,"interventions":211,"overallOfficials":301,"centralContacts":308,"locations":319,"responsibleParty":344,"collaborators":347,"id":352,"slug":168,"hasResults":353,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":353,"sex":359,"minAge":360,"maxAge":168,"enrollmentInfo":361,"targetDuration":168,"studyType":364,"phases":365,"briefSummary":367,"conditions":368,"keywords":371,"overallStatus":322,"whyStopped":168,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":387},{"fullName":5,"class":6},"San Diego State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":168},[9,13],{"measure":10,"description":11,"timeFrame":12},"Physical Therapy Referral","Proportion of enrolled patients who receive an internal or external referral to physical therapy following Primary Care Provider (PCP) index encounter for a new or existing episode of spine pain.","Patient level: 3-months after index PCP encounter; Clinic level: 6-, 12-, 18-, and 24-months after start of trial",{"measure":14,"description":15,"timeFrame":16},"Physical Therapy Adherence","Proportion of enrolled patients who complete a physical therapy evaluation at the Federally Qualified Health Center following an internal referral to physical therapy for a new or existing episode of spine pain.","Patient level: 6-months after index physical therapy referral; Clinic level: 6-, 12-, 18-, and 24-months after start of trial",[18,22,26,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78,81,84,87,90,94,97,100,104,107,110,113,116,119,122,125,129,133,136,139,143,147,150,153,156,159,162,165],{"measure":19,"description":20,"timeFrame":21},"Maintenance Physical Therapy Referral","Proportion of enrolled patients who receive an internal or external referral to PT following Primary Care Provider (PCP) index encounter for a new or existing episode of spine pain during the maintenance phase.","Patient level: 3-months after index PCP encounter; Clinic level: 30-months after start of trial",{"measure":23,"description":24,"timeFrame":25},"Maintenance Physical Therapy Adherence","Proportion of enrolled patients who complete a physical therapy evaluation at the Federally Qualified Health Center following an internal referral to physical therapy for a new or existing episode of spine pain during the maintenance phase.","Patient level: 6-months after index physical therapy referral; Clinic level: 30-months after start of trial",{"measure":27,"description":28,"timeFrame":29},"Patient age","Patient age in years recorded in electronic health record","Upon enrollment",{"measure":31,"description":32,"timeFrame":29},"Patient sex","Patient sex at birth recorded in electronic health record",{"measure":34,"description":35,"timeFrame":29},"Patient race","Patient race recorded in electronic health record",{"measure":37,"description":38,"timeFrame":29},"Patient ethnicity","Patient ethnicity recorded in electronic health record",{"measure":40,"description":41,"timeFrame":29},"Patient birth place","Patient country of birth recorded in electronic health record",{"measure":43,"description":44,"timeFrame":29},"Patient education","Patient highest level of education recorded in electronic health record",{"measure":46,"description":47,"timeFrame":29},"Patient employment","Patient employment status recorded in electronic health record",{"measure":49,"description":50,"timeFrame":29},"Patient relationship status","Patient relationship status (e.g., married, divorced, etc.) recorded in electronic health record",{"measure":52,"description":53,"timeFrame":29},"Patient neighborhood status","Neighborhood healthy places index (HPI) score based on patient zipcode",{"measure":55,"description":56,"timeFrame":29},"Patient food insecurity","Patient food insecurity status based on PREPAR questionnaire recorded in electronic health record",{"measure":58,"description":59,"timeFrame":29},"Patient transportation status","Patient transportation status based on PRAPARE questionnaire recorded in electronic health record",{"measure":61,"description":62,"timeFrame":29},"Patient insurance","Patient insurance status (federal, private, uninsured, etc.) recorded in electronic health record",{"measure":64,"description":65,"timeFrame":29},"Patient language","Patient preferred language recorded in electronic health record",{"measure":67,"description":68,"timeFrame":29},"Patient interpreter","Patient request for interpreter during primary care visit recorded in electronic health record",{"measure":70,"description":71,"timeFrame":29},"Index clinic","Name of Federally Qualified Health Center clinic at which index encounter for spine pain occurred recorded in electronic health record",{"measure":73,"description":74,"timeFrame":29},"Spine pain region","Region of spine pain (neck, low back, both) recorded in electronic health record at index encounter",{"measure":76,"description":77,"timeFrame":29},"Spine pain acuity","New or existing spine pain problem recorded in electronic health record at index encounter",{"measure":79,"description":80,"timeFrame":29},"Patient comorbidity","Functional comorbidity index recorded in electronic health record",{"measure":82,"description":83,"timeFrame":29},"Patient existing prescriptions","Type and number of existing prescriptions recorded in electronic health record at index encounter",{"measure":85,"description":86,"timeFrame":29},"Patient new prescriptions","Type and number of new prescriptions recorded in electronic health record at index encounter",{"measure":88,"description":89,"timeFrame":29},"Patient referrals","Type and number of specialty referrals recorded in electronic health record at index encounter",{"measure":91,"description":92,"timeFrame":93},"Clinic size","Number of spine pain encounters during baseline period for each participating primary care clinic","Upon crossover to STEPPT",{"measure":95,"description":96,"timeFrame":93},"Clinic location","Geographic location of each participating primary care clinic",{"measure":98,"description":99,"timeFrame":93},"Clinic PT Services","Availability of onsite physical therapy services for each participating primary care clinic",{"measure":101,"description":102,"timeFrame":103},"Provider age","Ages of primary care providers employed at each participating clinic recorded in clinic operations records","6-, 12-, 18-, 24-, and 30-months after start of trial",{"measure":105,"description":106,"timeFrame":103},"Provider sex","Sex of primary care providers employed at each participating clinic recorded in clinic operations records",{"measure":108,"description":109,"timeFrame":103},"Provider race","Races of primary care providers employed at each participating clinic recorded in clinic operations records",{"measure":111,"description":112,"timeFrame":103},"Provider ethnicity","Ethnicities of primary care providers employed at each participating clinic recorded in clinic operations records",{"measure":114,"description":115,"timeFrame":103},"Provider education","Highest clinical degrees for primary care providers employed at participating clinics recorded in clinic operations records",{"measure":117,"description":118,"timeFrame":103},"Provider specialty","Types of clinical specialties for primary care providers employed at each participating clinic recorded in clinic operations records",{"measure":120,"description":121,"timeFrame":103},"Provider experience","Time elapsed between date of highest clinical degree for primary care providers at each participating clinic and date of index encounter",{"measure":123,"description":124,"timeFrame":103},"Duration of provider employment","Duration of employment at federally qualified health center for primary care providers at each participating clinic recorded in clinical operations records",{"measure":126,"description":127,"timeFrame":128},"PCP frequency of PT education","Primary care physician self-reported frequency of educating patients with spine pain about the benefits of physical therapy (never, rarely, sometimes, often, always)","Prior to training, 6-months after crossover to STEPPT",{"measure":130,"description":131,"timeFrame":132},"PCP qualitative interviews","Qualitative interviews with primary care providers to assess motivations, barriers, and facilitators for any changes made in the rate of physical therapy referral and the frequency, content, and approach for patient education on benefits of physical therapy","3-months after cross over to STEPPT",{"measure":134,"description":135,"timeFrame":128},"Allied provider frequency of PT education","Nurse and Medical Assistant self-reported frequency of educating patients about the benefits of physical therapy and referral process (never, rarely, sometimes, often, always)",{"measure":137,"description":138,"timeFrame":132},"Allied provider qualitative interviews","Qualitative interviews with nurses and medical assistants to assess motivations, barriers, and facilitators for any changes made in the rate of physical therapy referral and the frequency, content, and approach for patient education on benefits of physical therapy",{"measure":140,"description":141,"timeFrame":142},"Training Involvement Rating Scale (IRS) score","Scale ranging from 0-15 points quantifies unsatisfactory (0-5 points), moderate (6-10 points) and satisfactory (11-15 points) involvement of clinic staff in STEPPT trainings. IRS score assesses the following training domains: 1) clinic administrator orientation, 2) primary care physician orientation, 3) Nurse\u002FMedical Assistant orientation, 4) Review of progress reports, 5) ECN training and audit reviews","6-, 12-, 18-months after start of trial",{"measure":144,"description":145,"timeFrame":146},"ECN contact attempts","Number of enhanced care navigation call attempts prior to scheduling first physical therapy appointment","12-, 18-, 24-, and 30-months after start of trial",{"measure":148,"description":149,"timeFrame":146},"ECN completed contacts","Proportion of Hispanic patients referred to physical therapy who were able to be contacted by patient health navigator, regardless of whether enhanced care navigation was delivered",{"measure":151,"description":152,"timeFrame":146},"ECN delivery","Proportion of Hispanic patients who were successfully contacted for whom each mandatory component of enhanced care navigation was delivered",{"measure":154,"description":155,"timeFrame":146},"Order Printed PT Education Materials","Proportion of Hispanic patients with a new or existing spine pain problem who receive an auto-order for physical therapy education materials printed with the after visit summary at index encounter",{"measure":157,"description":158,"timeFrame":146},"Order Portal PT Education Materials","Proportion of Hispanic patients referred to physical therapy who receive an auto-order for electronic physical therapy education materials, referral information, and educational video in the patient portal",{"measure":160,"description":161,"timeFrame":146},"Order Text PT Education Materials","Proportion of Hispanic patients referred to physical therapy who are sent an auto-order for text link to physical therapy referral information and education video",{"measure":163,"description":164,"timeFrame":146},"Patient Portal Views","Proportion of Hispanic patients referred to physical therapy who view electronic physical therapy education materials, referral information, and education video from links provided in patient portal",{"measure":166,"description":167,"timeFrame":146},"Patient Text Views","Proportion of Hispanic patients referred to physical therapy who view physical therapy referral information and education video from links provided from the auto-text message",null,{"allocation":170,"interventionModel":171,"interventionModelDescription":172,"primaryPurpose":173,"observationalModel":168,"timePerspective":168,"maskingInfo":174},"RANDOMIZED","CROSSOVER","The STEPPT study will use a hybrid type 1, pragmatic stepped wedge cluster randomized trial (SW-CRT) design to evaluate implementation and effectiveness of a multi-level intervention aimed at improving rates of physical therapy referral and adherence among Hispanic patients with spine pain at a Federally Qualified Health Center. The unit of randomization is clinics. Outcomes will be assessed at the participant level.","HEALTH_SERVICES_RESEARCH",{"masking":175,"maskingDescription":176,"whoMasked":168},"NONE","The STEPPT trial will use single blind masking in which patients will remain blind to the study purpose and alternate care pathways (STEPPT Care vs. Usual Care) throughout the trial. Providers and clinic staff cannot be blinded due to the nature of the intervention (i.e., providers and staff require training to administer STEPPT and implement workflow changes). The order of cross-over from Usual Care to STEPPT will be concealed from investigators, providers, and staff until one month prior to each step in the SW-CRT. At this time, the statistician will communicate the clinics that have been randomly assigned to cross over to the FQHC Research Manager who will then initiate training activities which will unblind providers and staff. Primary and secondary outcomes will be assessed using automated algorithms applied to electronic health record (EHR) data to minimize bias. Investigators, providers, and staff will have access to these data for feedback and quality improvement purposes.","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 imbalance between steps, allocation of clinics will be balanced with respect to clinic size and historical rates of PT referral and adherence in the year prior to allocation. For each candidate allocation, an imbalance score summarizing differences across steps will be calculated and the randomization procedure will be repeated to identify the allocation yielding the smallest overall imbalance score as the final stepped-wedge assignment. The three steps will transition from Usual Care (control) to STEPPT (intervention) at 6-month intervals. A 6-month baseline period of Usual Care for all clinics will precede the first date of cross over into STEPPT. Implementation and effectiveness outcomes will be assessed at 6-month intervals throughout the trial.",[179,198],{"label":180,"type":181,"description":182,"interventionNames":183},"STEPPT Care Pathway","EXPERIMENTAL","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.",[184,185,186,187,188,189,190,191,192,193,194,195,196,197],"Behavioral: Engagement of clinic leadership (System Intervention - STEPPT)","Behavioral: Patient Registry (System Intervention - STEPPT)","Behavioral: Delivery of Patient Education Materials (System Intervention - STEPPT)","Behavioral: Patient Health Navigator Training (System Intervention - STEPPT)","Behavioral: Care Navigation (System Intervention - STEPPT)","Behavioral: Care navigation audit and feedback (System Intervention - STEPPT)","Behavioral: Primary Care Provider training (Provider Intervention - STEPPT)","Behavioral: Nurse\u002FMedical Assistant Training (Provider Intervention - STEPPT)","Behavioral: Provider feedback on PT referral and adherence (Provider Intervention - STEPPT)","Behavioral: Patient education on spine pain condition (Patient Intervention - STEPPT)","Behavioral: Patient Education on Physical Referral by Providers (Patient Intervention - STEPPT)","Behavioral: Electronic Patient Education on Physical Therapy Referral (Patient Intervention - STEPPT)","Behavioral: Patient education on physical therapy referral by Patient Health Navigator (Patient Intervention - STEPPT)","Behavioral: Monitoring of PT referral and adherence rates (System Intervention - STEPPT)",{"label":199,"type":200,"description":201,"interventionNames":202},"Usual Care Pathway (Control)","ACTIVE_COMPARATOR","The Usual Care Arm involves the current institutional standard of referral and scheduling processes. If a patient is referred to physical therapy, a centralized Referral Specialist verifies insurance and attempts to schedule the evaluation. No provider\u002Fstaff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.",[203,204,205,206,207,208,209,210],"Behavioral: Engagement of clinic leadership (System Intervention - Usual Care)","Behavioral: Delivery of Patient Education Materials (System Intervention - Usual Care)","Behavioral: Referral Specialist Training (System Intervention - Usual Care)","Behavioral: Patient education on spine pain condition (Patient Intervention - Usual Care)","Behavioral: Patient Education on Physical Referral by Providers (Patient Intervention - Usual Care)","Behavioral: Patient education on physical therapy referral by Referral Specialist (Patient Intervention - Usual Care)","Behavioral: Care Navigation (System Intervention - Usual Care)","Behavioral: Monitoring of PT referral and adherence rates (System intervention - Usual Care)",[212,217,221,225,229,233,237,241,245,249,253,257,261,265,269,273,277,281,285,289,293,297],{"type":213,"name":214,"description":215,"armGroupLabels":216,"otherNames":168},"BEHAVIORAL","Engagement of clinic leadership (System Intervention - Usual Care)","No engagement of clinic leadership in promotion or monitoring of PT referral patterns among providers or PT adherence patterns among patients",[199],{"type":213,"name":218,"description":219,"armGroupLabels":220,"otherNames":168},"Engagement of clinic leadership (System Intervention - STEPPT)","Clinic Directors and Charge Nurses engage in STEPPT onboarding meeting with STEPPT Project Manager to discuss STEPPT objectives, procedures, and need for local adaptations. Medical leaders champion provider training and facilitate change in practice patterns through regularly scheduled review of trends in PT referral and adherence patterns with STEPPT Project Manager.",[180],{"type":213,"name":222,"description":223,"armGroupLabels":224,"otherNames":168},"Patient Registry (System Intervention - STEPPT)","Patients referred to physical therapy for spine pain are stratified by ethnicity. Hispanic patients are added to STEPPT Patient Registry to facilitate targeted engagement of an underserved population known to have low rates of adherence for physical therapy referrals.",[180],{"type":213,"name":226,"description":227,"armGroupLabels":228,"otherNames":168},"Delivery of Patient Education Materials (System Intervention - Usual Care)","Neck or back pain fact sheet may be manually ordered in the printed after visit summary at the discretion of the primary care physician. No automated systems for delivery of patient education materials on spine pain or physical therapy referral.",[199],{"type":213,"name":230,"description":231,"armGroupLabels":232,"otherNames":168},"Delivery of Patient Education Materials (System Intervention - STEPPT)","Automated delivery systems for patient education materials include:\n\n* Auto-order for culturally tailored neck or back pain fact sheet, general PT fact sheet, and postural exercise fact sheet printed in the AVS for all Hispanic patients with a new or existing spine pain problem\n* Auto-order for text message with links to culturally tailored PT referral fact sheet and video upon referral to PT for spine pain\n* Auto-order for culturally tailored neck or back pain fact sheet, general PT fact sheet, postural exercise fact sheet, PT referral fact sheet, and video added to the patient portal upon referral to PT for spine pain",[180],{"type":213,"name":234,"description":235,"armGroupLabels":236,"otherNames":168},"Referral Specialist Training (System Intervention - Usual Care)","Referral Specialists trained in system-wide procedures for processing referrals, calling patients, and scheduling appointments for specialty services. Physical therapy referrals processed by a dedicated team of Physical Rehabilitation Services Referral Specialists.",[199],{"type":213,"name":238,"description":239,"armGroupLabels":240,"otherNames":168},"Patient Health Navigator Training (System Intervention - STEPPT)","Patient Health Navigators (PHNs) trained in system-wide procedures for processing referrals, calling patients, and scheduling appointments for specialty services. Additional training on patient communication and enhanced care navigation is provided to address cultural factors, individual barriers, and risk factors for non-adherence. Physical therapy referrals processed by a specially trained team of Physical Rehabilitation Services PHNs.",[180],{"type":213,"name":242,"description":243,"armGroupLabels":244,"otherNames":168},"Care Navigation (System Intervention - STEPPT)","Upon referral to PT and verification of insurance coverage, patients receive a system-generated auto-call to schedule the PT evaluation followed by up to 3 phone contact attempts by a Patient Health Navigator (PHN) to 1) deliver enhanced care navigation, and 2) schedule PT evaluation. Prior to scheduling, PHN delivers semi-scripted enhanced care navigation (ECN) with mandatory components:\n\n* Summarize benefits of PT\n* Emphasize importance of attending PT even if prescribed medication for temporary pain relief\n* Confirm patient received and reviewed educational materials. Resend materials, if needed\n* Address privacy concerns, if present\n* Address risk factors for PT non-adherence, if present: scheduling, cost, transportation barriers\n* Address other questions or concerns\n* Schedule the PT evaluation\n* Repeat appointment details and provide PHN contact information for additional questions",[180],{"type":213,"name":246,"description":247,"armGroupLabels":248,"otherNames":168},"Care navigation audit and feedback (System Intervention - STEPPT)","Audits of fidelity to enhanced care navigation protocol using self-report checklists and review of recorded phone calls are discussed monthly with PHNs to facilitate competent and consistent delivery of enhanced care navigation for patients in STEPPT registry.",[180],{"type":213,"name":250,"description":251,"armGroupLabels":252,"otherNames":168},"Primary Care Provider training (Provider Intervention - STEPPT)","PCPs attend training with Physical Rehabilitation Services site manager on the following topics:\n\n* STEPPT objectives, procedures, and patient education materials\n* Referral and adherence rates for PT among Hispanic patients at FQHC clinics\n* Benefits of PT referral for patients with new and existing spine pain problems\n* Culturally responsive strategies to improve patient engagement in PT services (e.g., explanation of how PT can improve family and social role functioning)",[180],{"type":213,"name":254,"description":255,"armGroupLabels":256,"otherNames":168},"Nurse\u002FMedical Assistant Training (Provider Intervention - STEPPT)","Nurses and MAs attend training with Physical Rehabilitation Services site manager on the following topics:\n\n* STEPPT objectives, procedures, and patient education materials\n* Referral and adherence rates for PT among Hispanic patients at FQHC clinics\n* Benefits of PT referral for patients with new and existing spine pain problems\n* Culturally responsive strategies to improve patient engagement in PT services (e.g., explanation of the FQHC referral process)",[180],{"type":213,"name":258,"description":259,"armGroupLabels":260,"otherNames":168},"Provider feedback on PT referral and adherence (Provider Intervention - STEPPT)","Trends in PT referral and adherence rates, stratified by ethnicity, are reviewed biannually at \"Provider Huddles\" along with suggestions for improvement as needed.",[180],{"type":213,"name":262,"description":263,"armGroupLabels":264,"otherNames":168},"Patient education on spine pain condition (Patient Intervention - Usual Care)","Verbal patient education on etiology, treatment, and prognosis for spine pain may be provided at the discretion of Primary Care Physician. Back Pain or Neck Pain Fact Sheet may be ordered in the printed After Visit Summary at the discretion of Primary Care Physician. Back Pain\u002FNeck Pain Factsheet summarizes current evidence on etiology, prognosis, and treatment (medical and self-management) for back or neck pain. \\[Available in English or Spanish language\\]",[199],{"type":213,"name":266,"description":267,"armGroupLabels":268,"otherNames":168},"Patient education on spine pain condition (Patient Intervention - STEPPT)","Verbal patient education on etiology, treatment, and prognosis for spine pain may be provided at the discretion of Primary Care Physician. Patient education materials auto-ordered in the printed After Visit Summary for all patients with a new or existing spine pain problem on the electronic health record Problem List. STEPPT patient education materials include: (1) Back Pain or Neck Pain Facts, a culturally tailored factsheet summarizing current evidence on etiology, prognosis, and treatment (medical and self-management) for back or neck pain, (2) Physical Therapy Fact Sheet, culturally tailored information describing physical therapy evaluation and treatment options for pain with a QR code linking to a Physical Therapy Education Video, (3) Posture Exercises, culturally tailored instructions for standing posture, seated posture, and supine diaphragmatic breathing. \\[All patient education materials available in English or Spanish language\\]",[180],{"type":213,"name":270,"description":271,"armGroupLabels":272,"otherNames":168},"Patient Education on Physical Referral by Providers (Patient Intervention - Usual Care)","Verbal patient education on physical therapy referral may be provided at the discretion of Primary Care Physician, Nurse, and\u002For Medical Assistant at index encounter. Patients are notified of referral for physical therapy consultation in the printed After Visit Summary. No written instructions on physical therapy referral process are provided.",[199],{"type":213,"name":274,"description":275,"armGroupLabels":276,"otherNames":168},"Patient Education on Physical Referral by Providers (Patient Intervention - STEPPT)","Following training in best practices, primary care providers encouraged to provide culturally responsive patient education on benefits of PT for spine pain at index encounter. Nurses and medical assistants encouraged to review printed patient education materials on benefits of PT and institutional referral process. Patients are notified of referral for physical therapy consultation in the printed After Visit Summary at index encounter.",[180],{"type":213,"name":278,"description":279,"armGroupLabels":280,"otherNames":168},"Electronic Patient Education on Physical Therapy Referral (Patient Intervention - STEPPT)","Patient receives auto-email from patient portal and auto-text message with links to electronic patient education materials upon being referred to PT:\n\n* Physical Therapy Referral Information - Culturally tailored information highlighting the importance of attending PT, resources to support regular attendance, and instructions for scheduling and preparing for the PT evaluation. \\[Eng\u002FSpan\\]\n* Physical Therapy Education Video - Culturally tailored video showing how to schedule and attend the PT evaluation with testimonials from former FQHC patients highlighting benefits of PT for spine pain. \\[Eng\u002FSpan\\]",[180],{"type":213,"name":282,"description":283,"armGroupLabels":284,"otherNames":168},"Patient education on physical therapy referral by Referral Specialist (Patient Intervention - Usual Care)","Verbal patient education on physical therapy referral may be provided at the discretion of the Referral Specialist when scheduling the physical therapy consultation.",[199],{"type":213,"name":286,"description":287,"armGroupLabels":288,"otherNames":168},"Patient education on physical therapy referral by Patient Health Navigator (Patient Intervention - STEPPT)","Culturally responsive, semi-scripted patient education on benefits of physical therapy and logistics of physical therapy appointments provided verbally by a Patient Health Navigator (PHN) when scheduling the physical therapy consultation. PHN identifies and helps mitigate individual barriers for attending physical therapy appointments.",[180],{"type":213,"name":290,"description":291,"armGroupLabels":292,"otherNames":168},"Care Navigation (System Intervention - Usual Care)","Upon PT referral and verification of insurance coverage, patient receives up to 2 system-generated auto-calls to schedule PT evaluation. If no contact is made after 30 days, a system-generated letter is sent by mail requesting the patient call a centralized Referral Specialist to schedule the PT evaluation. Additional care navigation services may be provided at the discretion of the Referral Specialist.",[199],{"type":213,"name":294,"description":295,"armGroupLabels":296,"otherNames":168},"Monitoring of PT referral and adherence rates (System Intervention - STEPPT)","Automated EHR analysis monitors daily PT referral and adherence rates for spine pain. PowerBI custom graphical interface with monthly trends in PT referral and adherence rates, stratified by ethnicity, are reviewed biannually by Vice President of Specialty Services, Physical Rehabilitation Services site manager, medical leadership, and providers.",[180],{"type":213,"name":298,"description":299,"armGroupLabels":300,"otherNames":168},"Monitoring of PT referral and adherence rates (System intervention - Usual Care)","PT referral and adherence rates monitored as needed by Vice President of Specialty Services.",[199],[302,305],{"name":303,"affiliation":5,"role":304},"Katrina Monroe, PT, PhD","PRINCIPAL_INVESTIGATOR",{"name":306,"affiliation":307,"role":304},"Sara Gombatto, PT, PhD","San Diego State University Research Foundation",[309,314],{"name":310,"role":311,"phone":312,"phoneExt":168,"email":313},"Cheenee R Real, BSN, MPH, MSOL","CONTACT","323-508-6312","creal2@sdsu.edu",{"name":315,"role":311,"phone":316,"phoneExt":317,"email":318},"Shadia Assi, BS, MPH","619-515-2300","3337","shadiaa@fhcsd.org",[320],{"facility":321,"status":322,"city":323,"state":324,"zip":325,"country":326,"countryCode":327,"cosmosGeoPoint":328,"geoPoint":333,"contacts":334},"Family Health Centers of San Diego","RECRUITING","San Diego","California","92182","United States","US",{"type":329,"coordinates":330},"Point",[331,332],-117.16472,32.71571,{"lat":332,"lon":331},[335,340,341],{"name":336,"role":311,"phone":337,"phoneExt":338,"email":339},"Job Godino, PhD","619-515-2344","2344","jobg@fhcsd.org",{"name":315,"role":311,"phone":316,"phoneExt":317,"email":318},{"name":342,"role":343,"phone":168,"phoneExt":168,"email":168},"Jason Van Dyke, MSPT","SUB_INVESTIGATOR",{"type":304,"investigatorFullName":345,"investigatorTitle":346,"investigatorAffiliation":5,"oldNameTitle":168,"oldOrganization":168},"Katrina Monroe","PT, PhD",[348,351],{"name":349,"class":350},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH",{"name":321,"class":6},"100615265",false,"NCT07290361","Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)","Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT): A Pragmatic Stepped Wedge Cluster Randomized Trial","STEPPT","Inclusion Criteria\n\n* 18 years or older.\n* Identify as either Hispanic or Non-Hispanic ethnicity, inclusive of all races.\n* Seeking care for spine pain at an Adult or Adult Walk-in primary care clinic within the participating Federally Qualified Health Center (FQHC).\n* New or existing spine pain problem: A new spine pain problem is defined by a new ICD code for neck or back pain added to the problem list during a visit with a primary care physician. An existing spine pain problem is defined by 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.\n* Signed a broad consent for the use of de-identified health information for research at the participating FQHC.\n\nExclusion Criteria:\n\n* Spine pain associated with a non-musculoskeletal etiology (e.g., infection, cancer, urological disorders, pregnancy, etc.)\n* Patients requiring urgent medical intervention (e.g., fracture, cauda equina syndrome, etc)\n* Active physical therapy referral for spine pain at the time of the index encounter.\n* Previously referred to physical therapy through the STEPPT Care Pathway.\n* Physical therapy referrals external to the FQHC will be excluded from the analysis of physical therapy adherence","ALL","18 Years",{"count":362,"type":363},17587,"ESTIMATED","INTERVENTIONAL",[366],"NA","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.",[369,370],"Low Back Pain","Neck Pain",[372,373,374,375,376,377],"Physical therapy","Rehabilitation","Hispanic","Heatlh Services","Healthcare utilization","Federally Qualified Health Center","2026-02-03",{"date":380,"type":381},"2026-02-06","ACTUAL",{"date":383,"type":381},"2025-12-01",{"date":385,"type":363},"2029-02-28",{"name":5,"class":6},1]