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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009726', 'term': 'Nurses'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17587}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-14', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline Physical Therapy Referral', 'timeFrame': '3-months after index PCP encounter', 'description': '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 during the baseline phase.'}, {'measure': 'Intervention Physical Therapy Referral', 'timeFrame': '3-months after index PCP encounter', 'description': '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 during the intervention phase.'}, {'measure': 'Baseline Physical Therapy Adherence', 'timeFrame': '6-months after index physical therapy referral', 'description': '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 baseline phase.'}, {'measure': 'Intervention Physical Therapy Adherence', 'timeFrame': '6-months after index physical therapy referral', 'description': '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 intervention phase.'}], 'secondaryOutcomes': [{'measure': 'Maintenance Physical Therapy Referral', 'timeFrame': '3-months after index PCP encounter', 'description': '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.'}, {'measure': 'Maintenance Physical Therapy Adherence', 'timeFrame': '6-months after index physical therapy referral', 'description': '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.'}, {'measure': 'Patient age', 'timeFrame': 'Upon enrollment', 'description': 'Patient age in years recorded in electronic health record'}, {'measure': 'Patient sex', 'timeFrame': 'Upon enrollment', 'description': 'Patient sex at birth recorded in electronic health record'}, {'measure': 'Patient race', 'timeFrame': 'Upon enrollment', 'description': 'Patient race recorded in electronic health record'}, {'measure': 'Patient ethnicity', 'timeFrame': 'Upon enrollment', 'description': 'Patient ethnicity recorded in electronic health record'}, {'measure': 'Patient birth place', 'timeFrame': 'Upon enrollment', 'description': 'Patient country of birth recorded in electronic health record'}, {'measure': 'Patient education', 'timeFrame': 'Upon enrollment', 'description': 'Patient highest level of education recorded in electronic health record'}, {'measure': 'Patient employment', 'timeFrame': 'Upon enrollment', 'description': 'Patient employment status recorded in electronic health record'}, {'measure': 'Patient relationship status', 'timeFrame': 'Upon enrollment', 'description': 'Patient relationship status (e.g., married, divorced, etc.) recorded in electronic health record'}, {'measure': 'Patient neighborhood status', 'timeFrame': 'Upon enrollment', 'description': 'Neighborhood healthy places index (HPI) score based on patient zipcode'}, {'measure': 'Patient food insecurity', 'timeFrame': 'Upon enrollment', 'description': 'Patient food insecurity status based on PREPAR questionnaire recorded in electronic health record'}, {'measure': 'Patient transportation status', 'timeFrame': 'Upon enrollment', 'description': 'Patient transportation status based on PRAPARE questionnaire recorded in electronic health record'}, {'measure': 'Patient insurance', 'timeFrame': 'Upon enrollment', 'description': 'Patient insurance status (federal, private, uninsured, etc.) recorded in electronic health record'}, {'measure': 'Patient language', 'timeFrame': 'Upon enrollment', 'description': 'Patient preferred language recorded in electronic health record'}, {'measure': 'Patient interpreter', 'timeFrame': 'Upon enrollment', 'description': 'Patient request for interpreter during primary care visit recorded in electronic health record'}, {'measure': 'Index clinic', 'timeFrame': 'Upon enrollment', 'description': 'Name of Federally Qualified Health Center clinic at which index encounter for spine pain occurred recorded in electronic health record'}, {'measure': 'Spine pain region', 'timeFrame': 'Upon enrollment', 'description': 'Region of spine pain (neck, low back, both) recorded in electronic health record at index encounter'}, {'measure': 'Spine pain acuity', 'timeFrame': 'Upon enrollment', 'description': 'New or existing spine pain problem recorded in electronic health record at index encounter'}, {'measure': 'Patient comorbidity', 'timeFrame': 'Upon enrollment', 'description': 'Functional comorbidity index recorded in electronic health record'}, {'measure': 'Patient existing prescriptions', 'timeFrame': 'Upon enrollment', 'description': 'Type and number of existing prescriptions recorded in electronic health record at index encounter'}, {'measure': 'Patient new prescriptions', 'timeFrame': 'Upon enrollment', 'description': 'Type and number of new prescriptions recorded in electronic health record at index encounter'}, {'measure': 'Patient referrals', 'timeFrame': 'Upon enrollment', 'description': 'Type and number of specialty referrals recorded in electronic health record at index encounter'}, {'measure': 'Clinic size', 'timeFrame': '6-mo baseline prior to cross over', 'description': 'Number of spine pain encounters during baseline period for each participating primary care clinic'}, {'measure': 'Clinic location', 'timeFrame': '6-mo baseline prior to crossover', 'description': 'Geographic location of each participating primary care clinic'}, {'measure': 'Clinic PT Services', 'timeFrame': '6-mo baseline prior to cross over', 'description': 'Availability of onsite physical therapy services for each participating primary care clinic'}, {'measure': 'Provider age', 'timeFrame': '6-, 12-, 18-, 24-, and 30-months after start of trial', 'description': 'Ages of primary care providers employed at each participating clinic recorded in clinic operations records'}, {'measure': 'Provider sex', 'timeFrame': '6-, 12-, 18-, 24-, and 30-months after start of trial', 'description': 'Sex of primary care providers employed at each participating clinic recorded in clinic operations records'}, {'measure': 'Provider race', 'timeFrame': '6-, 12-, 18-, 24-, and 30-months after start of trial', 'description': 'Races of primary care providers employed at each participating clinic recorded in clinic operations records'}, {'measure': 'Provider ethnicity', 'timeFrame': '6-, 12-, 18-, 24-, and 30-months after start of trial', 'description': 'Ethnicities of primary care providers employed at each participating clinic recorded in clinic operations records'}, {'measure': 'Provider education', 'timeFrame': '6-, 12-, 18-, 24-, and 30-months after start of trial', 'description': 'Highest clinical degrees for primary care providers employed at participating clinics recorded in clinic operations records'}, {'measure': 'Provider specialty', 'timeFrame': '6-, 12-, 18-, 24-, and 30-months after start of trial', 'description': 'Types of clinical specialties for primary care providers employed at each participating clinic recorded in clinic operations records'}, {'measure': 'Provider experience', 'timeFrame': '6-, 12-, 18-, 24-, and 30-months after start of trial', 'description': 'Time elapsed between date of highest clinical degree for primary care providers at each participating clinic and date of index encounter'}, {'measure': 'Duration of provider employment', 'timeFrame': '6-, 12-, 18-, 24-, and 30-months after start of trial', 'description': 'Duration of employment at federally qualified health center for primary care providers at each participating clinic recorded in clinical operations records'}, {'measure': 'PCP frequency of PT education', 'timeFrame': '6-, 12-, 18-, 24-, and 30-months after start of trial', 'description': 'Primary care physician self-reported frequency of educating patients with spine pain about the benefits of physical therapy (never, rarely, sometimes, often, always)'}, {'measure': 'PCP qualitative interviews', 'timeFrame': '3-months after cross over to STEPPT', 'description': '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'}, {'measure': 'Allied provider frequency of PT education', 'timeFrame': '6-, 12-, 18-, 24-, and 30-months after start of trial', 'description': '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': 'Allied provider qualitative interviews', 'timeFrame': '3-months after cross over to STEPPT', 'description': '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': 'Training Involvement Rating Scale (IRS) score', 'timeFrame': '6-, 12-, 18-months after start of trial', 'description': '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/Medical Assistant orientation, 4) Review of progress reports, 5) ECN training and audit reviews'}, {'measure': 'ECN contact attempts', 'timeFrame': '12-, 18-, 24-, and 30-months after start of trial', 'description': 'Number of enhanced care navigation call attempts prior to scheduling first physical therapy appointment'}, {'measure': 'ECN completed contacts', 'timeFrame': '12-, 18-, 24-, and 30-months after start of trial', 'description': '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': 'ECN delivery', 'timeFrame': '12-, 18-, 24-, and 30-months after start of trial', 'description': 'Proportion of Hispanic patients who were successfully contacted for whom each mandatory component of enhanced care navigation was delivered'}, {'measure': 'Order Printed PT Education Materials', 'timeFrame': '12-, 18-, 24-, and 30-months after start of trial', 'description': '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': 'Order Portal PT Education Materials', 'timeFrame': '12-, 18-, 24-, and 30-months after start of trial', 'description': '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': 'Order Text PT Education Materials', 'timeFrame': '12-, 18-, 24-, and 30-months after start of trial', 'description': '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': 'Patient Portal Views', 'timeFrame': '12-, 18-, 24-, and 30-months after start of trial', 'description': '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': 'Patient Text Views', 'timeFrame': '12-, 18-, 24-, and 30-months after start of trial', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical therapy', 'Rehabilitation', 'Hispanic', 'Heatlh Services', 'Healthcare utilization', 'Federally Qualified Health Center'], 'conditions': ['Low Back Pain', 'Neck Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07290361', 'acronym': 'STEPPT', 'briefTitle': 'Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT): A Pragmatic Stepped Wedge Cluster Randomized Trial', 'orgStudyIdInfo': {'id': 'HS-2023-0122'}, 'secondaryIdInfos': [{'id': 'R01MD018937', 'link': 'https://reporter.nih.gov/quickSearch/R01MD018937', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STEPPT Care Pathway', 'description': '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.', 'interventionNames': ['Behavioral: Physical therapy referral and adherence monitoring (System Intervention - STEPPT)', 'Behavioral: Patient Registry (System Intervention - STEPPT)', 'Behavioral: Delivery of Patient Education Materials (System Intervention - STEPPT)', 'Behavioral: Engagement of clinic leadership (Systems Intervention - STEPPT)', 'Behavioral: Patient Health Navigator Training (System Intervention - STEPPT)', 'Behavioral: Scheduling the physical therapy consultation (System Intervention - STEPPT)', 'Behavioral: Enhanced Care Navigation (System Intervention - STEPPT)', 'Behavioral: Care navigation audit and feedback (System Intervention - STEPPT)', 'Behavioral: Primary Care Provider training (Provider Intervention - STEPPT)', 'Behavioral: Nurse/Medical Assistant Training (Provider Intervention - STEPPT)', 'Behavioral: Feedback to Clinic Administrators (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)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Pathway (Control)', 'description': "The Usual Care Arm involves a medical evaluation by a primary care provider who may prescribe any combination of self-management advice, patient education, medication, physical therapy, chiropractic, or specialist care at the provider's discretion. If referred to physical therapy, a centralized Referral Specialist verifies insurance and attempts to schedule the evaluation. No culturally tailored education, enhanced navigation, or provider/staff training is provided beyond the current standard of care.", 'interventionNames': ['Behavioral: Physical therapy referral and adherence monitoring (System Intervention - Usual Care)', 'Behavioral: Delivery of Patient Education Materials (System Intervention - Usual Care)', 'Behavioral: Referral Specialist Training (System Intervention - Usual Care)', 'Behavioral: Scheduling the Physical Therapy Consultation (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)']}], 'interventions': [{'name': 'Physical therapy referral and adherence monitoring (System Intervention - Usual Care)', 'type': 'BEHAVIORAL', 'description': 'Physical therapy referral and adherence rates monitored as needed by Director of Physical Rehabilitation Services', 'armGroupLabels': ['Usual Care Pathway (Control)']}, {'name': 'Physical therapy referral and adherence monitoring (System Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Automated analysis of electronic health record monitors daily physical therapy referral and adherence rates for patient with spine pain. PowerBI custom graphical interface with monthly trends in physical therapy referral and adherence rates, stratified by ethnicity, are reviewed by Clinic Director and Charge Nurse. Monthly engagement meetings are conducted with medical leadership to review and support progress toward physical therapy referral and adherence goals.', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Patient Registry (System Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Delivery of Patient Education Materials (System Intervention - Usual Care)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Usual Care Pathway (Control)']}, {'name': 'Delivery of Patient Education Materials (System Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Automated delivery systems for patient education materials include: (1) Auto-order for culturally tailored neck or back pain fact sheet and general physical therapy fact sheet printed in the after visit summary for all patients with a new or existing spine pain problem, (2) Auto-order for text message with links to culturally tailored physical therapy referral fact sheet and video upon referral to physical therapy for spine pain, and (3) Auto-order for culturally tailored neck and back pain fact sheet, general physical therapy fact sheet, postural exercise fact sheet, and physical therapy referral fact sheet and video added to the patient portal upon referral to physical therapy for spine pain', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Engagement of clinic leadership (Systems Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Onboarding meeting with Clinic Directors and Charge Nurses to engage leadership in STEPPT objectives, procedures, and need for local adaptations. Medical leaders champion provider training and facilitate change in practice patterns through monthly review and discussion of trends in physical therapy referral and adherence patterns.', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Referral Specialist Training (System Intervention - Usual Care)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Usual Care Pathway (Control)']}, {'name': 'Patient Health Navigator Training (System Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Scheduling the Physical Therapy Consultation (System Intervention - Usual Care)', 'type': 'BEHAVIORAL', 'description': 'Upon physical therapy referral and verification of insurance coverage, patient receives system-generated auto-call to schedule the physical therapy consultation. Auto-call is followed by up to 3 phone contact attempts by Referral Specialist to schedule the physical therapy consultation if not scheduled during auto-call. If no contact is made after 3 attempts, a system-generated letter is sent by mail requesting the patient call a centralized Referral Specialist to schedule the physical therapyconsultation.', 'armGroupLabels': ['Usual Care Pathway (Control)']}, {'name': 'Scheduling the physical therapy consultation (System Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Upon referral to physical therapy and verification of insurance coverage, patients in STEPPT registry receive a system-generated auto-call to schedule the physical therapy consultation. Auto-call is followed by up to 3 phone contact attempts by a Patient Health Navigator to 1) deliver enhanced care navigation, and 2) schedule the physical therapy consultation if not already scheduled during auto-call. If no contact is made after 3 attempts, a system-generated letter is sent by mail requesting the patient call a centralized Referral Specialist to schedule the physical therapy consultation', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Enhanced Care Navigation (System Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Patient Health Navigator delivers culturally responsive, semi-scripted enhanced care navigation to identify and mitigate barriers for attending physical therapy when scheduling the physical therapy consultation. Mandatory components of enhanced care navigation include: (1) Summarize benefits of physical therapy, (2) Stress importance of attending physical therapy even if prescribed medication for temporary pain relief, (3) Confirm receipt and review of patient educational materials; resend materials if needed, (4) Address privacy concerns, if present, (5) Address scheduling, cost, and transportation barriers, if present, (6) Address other questions or concerns, (7) Schedule the physical therapy consultation, and (8) Repeat appointment details and provide contact information for additional questions', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Care navigation audit and feedback (System Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Monthly audits of enhanced care navigation fidelity using self-report checklists and review of recorded phone calls are discussed with Patient Health Navigators to facilitate competent and consistent delivery of enhanced care navigation for patients in STEPPT registry.', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Primary Care Provider training (Provider Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Primary care physicians attend an in-service presentation from the Director of Physical Rehabilitation Services on the following topics: (1) Benefits of physical therapy referral for patients with new and existing spine pain problems, (2) Low referral and adherence rates for physical therapy among Hispanic patients at Federally Qualified Health Center clinics, (3) Culturally responsive strategies to improve patient engagement in physical therapy services, and (4) Review of STEPPT objectives, procedures, and patient education materials.', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Nurse/Medical Assistant Training (Provider Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Nurses and Medical Assistants attend an in-service presentation from the on the following topics: (1) Benefits of physical therapy referral for patients with new and existing spine pain problems, (2) Low referral and adherence rates for physical therapy among Hispanic patients at Federally Qualified Health Center clinics, (3) Culturally responsive strategies to improve patient engagement in physical therapy services, and (4) Review of STEPPT objectives, procedures, and patient education materials.', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Feedback to Clinic Administrators (Provider Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Clinic administrators receive written reports on trends in physical therapy referral and adherence rates, stratified by ethnicity. Reports are reviewed by administrators and distributed to providers along with suggestions for improvement as needed.', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Patient education on spine pain condition (Patient Intervention - Usual Care)', 'type': 'BEHAVIORAL', 'description': '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/Neck 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\\]', 'armGroupLabels': ['Usual Care Pathway (Control)']}, {'name': 'Patient education on spine pain condition (Patient Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': '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\\]', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Patient Education on Physical Referral by Providers (Patient Intervention - Usual Care)', 'type': 'BEHAVIORAL', 'description': 'Verbal patient education on physical therapy referral may be provided at the discretion of Primary Care Physician, Nurse, and/or 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.', 'armGroupLabels': ['Usual Care Pathway (Control)']}, {'name': 'Patient Education on Physical Referral by Providers (Patient Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Primary Care Physicians are encouraged to provide culturally responsive patient education on benefits of physical therapy for spine pain, while Nurses and Medical Assistants are encouraged to provide culturally responsive patient education on the referral process and importance of attending physical therapy at the index encounter. Patients are notified of referral for physical therapy consultation in the printed After Visit Summary at index encounter.', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Electronic Patient Education on Physical Therapy Referral (Patient Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': 'Upon referral to physical therapy, patients receive an automated text message and email with links to electronic patient education materials available online and in the patient portal. Education materials include (1) Physical Therapy Referral Factsheet, culturally tailored information highlighting the importance of attending physical therapy, resources to support attendance, and instructions for scheduling and preparing for the physical therapy consultation, and (2) Physical Therapy Education Video, a culturally tailored video showing how to schedule and attend physical therapy at the Federally Qualified Health Center. \\[All education materials available in English or Spanish language\\]', 'armGroupLabels': ['STEPPT Care Pathway']}, {'name': 'Patient education on physical therapy referral by Referral Specialist (Patient Intervention - Usual Care)', 'type': 'BEHAVIORAL', 'description': 'Verbal patient education on physical therapy referral may be provided at the discretion of the Referral Specialist when scheduling the physical therapy consultation.', 'armGroupLabels': ['Usual Care Pathway (Control)']}, {'name': 'Patient education on physical therapy referral by Patient Health Navigator (Patient Intervention - STEPPT)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['STEPPT Care Pathway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92182', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Job Godino, PhD', 'role': 'CONTACT', 'email': 'jobg@fhcsd.org', 'phone': '619-515-2344', 'phoneExt': '2344'}, {'name': 'Shadia Assi, BS, MPH', 'role': 'CONTACT', 'email': 'shadiaa@fhcsd.org', 'phone': '619-515-2300', 'phoneExt': '3337'}, {'name': 'Jason Van Dyke, MSPT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Family Health Centers of San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Cheenee R Real, BSN, MPH, MSOL', 'role': 'CONTACT', 'email': 'creal2@sdsu.edu', 'phone': '323-508-6312'}, {'name': 'Shadia Assi, BS, MPH', 'role': 'CONTACT', 'email': 'shadiaa@fhcsd.org', 'phone': '619-515-2300', 'phoneExt': '3337'}], 'overallOfficials': [{'name': 'Katrina Monroe, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego State University'}, {'name': 'Sara Gombatto, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego State University Research Foundation'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available beginning 12 months after publication of primary results and for a period of 5 years thereafter.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) underlying published results will be shared via the Open Science Framework (OSF) repository, along with the study protocol, data dictionaries, statistical analysis plan, and intervention materials.', 'accessCriteria': 'Researchers must submit a written request and scientific justification for access to IPD and provide a data use agreement outlining compliance with confidentiality and ethical standards. Requests will be reviewed by the multiple principal investigator team and the FQHC research oversight committee. If approved, access will be granted through permissions in the Open Science Framework repository. Supporting materials will include the study protocol, data dictionaries, statistical analysis plan, and intervention materials.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}, {'name': 'Family Health Centers of San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, PhD', 'investigatorFullName': 'Katrina Monroe', 'investigatorAffiliation': 'San Diego State University'}}}}