Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT): A Pragmatic Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 17,587
- 试验地点
- 1
- 主要终点
- Physical Therapy Referral
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Although patients cannot be blinded to embedded care processes, they will not be informed of alternate care pathways to minimize bias. Clinic providers and staff cannot be blinded because they require training to administer STEPPT and implement workflow changes. Randomization of crossover sequences will be performed by the study statistician at the start of the study with order assignments sealed in sequentially numbered opaque envelopes. Six weeks prior to cross-over for each step, clinic assignments will communicated to the STEPPT Project Manager who will notify Clinic Directors of their assigned date for crossover. Provider training sessions will be scheduled within 4 weeks of crossover at which time providers will be unblinded. 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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older.
- •Identify as either Hispanic or Non-Hispanic ethnicity, inclusive of all races.
- •Seeking care for spine pain at an Adult or Adult Walk-in primary care clinic within the participating Federally Qualified Health Center (FQHC).
- •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.
- •Signed a broad consent for the use of de-identified health information for research at the participating FQHC.
排除标准
- •Spine pain associated with a non-musculoskeletal etiology (e.g., infection, cancer, urological disorders, pregnancy, etc.)
- •Patients requiring urgent medical intervention (e.g., fracture, cauda equina syndrome, etc)
- •Active physical therapy referral for spine pain at the time of the index encounter.
- •Previously referred to physical therapy through the STEPPT Care Pathway.
- •Physical therapy referrals external to the FQHC will be excluded from the analysis of physical therapy adherence
研究组 & 干预措施
Usual Care Pathway (Control)
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/staff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.
干预措施: Engagement of clinic leadership (System Intervention - Usual Care) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Electronic Patient Education on Physical Therapy Referral (Patient Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Engagement of clinic leadership (System Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Patient Registry (System Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Delivery of Patient Education Materials (System Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Patient Health Navigator Training (System Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Care Navigation (System Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Care navigation audit and feedback (System Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Primary Care Provider training (Provider Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Nurse/Medical Assistant Training (Provider Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Provider feedback on PT referral and adherence (Provider Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Patient education on spine pain condition (Patient Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Patient Education on Physical Referral by Providers (Patient Intervention - STEPPT) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Patient education on physical therapy referral by Patient Health Navigator (Patient Intervention - STEPPT) (Behavioral)
Usual Care Pathway (Control)
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/staff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.
干预措施: Referral Specialist Training (System Intervention - Usual Care) (Behavioral)
STEPPT Care Pathway
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.
干预措施: Monitoring of PT referral and adherence rates (System Intervention - STEPPT) (Behavioral)
Usual Care Pathway (Control)
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/staff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.
干预措施: Delivery of Patient Education Materials (System Intervention - Usual Care) (Behavioral)
Usual Care Pathway (Control)
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/staff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.
干预措施: Patient education on spine pain condition (Patient Intervention - Usual Care) (Behavioral)
Usual Care Pathway (Control)
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/staff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.
干预措施: Patient Education on Physical Referral by Providers (Patient Intervention - Usual Care) (Behavioral)
Usual Care Pathway (Control)
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/staff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.
干预措施: Patient education on physical therapy referral by Referral Specialist (Patient Intervention - Usual Care) (Behavioral)
Usual Care Pathway (Control)
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/staff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.
干预措施: Care Navigation (System Intervention - Usual Care) (Behavioral)
Usual Care Pathway (Control)
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/staff training, culturally tailored patient education, or enhanced care navigation is provided beyond the current standard of care.
干预措施: Monitoring of PT referral and adherence rates (System intervention - Usual Care) (Behavioral)
结局指标
主要结局
Physical Therapy Referral
时间窗: Patient level: 3-months after index PCP encounter; Clinic level: 6-, 12-, 18-, and 24-months after start of trial
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.
Physical Therapy Adherence
时间窗: Patient level: 6-months after index physical therapy referral; Clinic level: 6-, 12-, 18-, and 24-months after start of trial
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.
次要结局
- Training Involvement Rating Scale (IRS) score(12-, 18-, 24--months after start of trial)
- Maintenance Physical Therapy Referral(Patient level: 3-months after index PCP encounter; Clinic level: 30-months after start of trial)
- Maintenance Physical Therapy Adherence(Patient level: 6-months after index physical therapy referral; Clinic level: 30-months after start of trial)
- Clinic size(Upon crossover to STEPPT)
- Clinic location(Upon crossover to STEPPT)
- Clinic PT Services(Upon crossover to STEPPT)
- PCP frequency of PT education(Prior to training, 6-months after crossover to STEPPT)
- Allied provider frequency of PT education(Prior to training, 6-months after crossover to STEPPT)
- ECN contact attempts(12-, 18-, 24-, and 30-months after start of trial)
- Patient comorbidity(Upon enrollment)
- Patient age(Upon enrollment)
- Patient sex(Upon enrollment)
- Patient race(Upon enrollment)
- Patient ethnicity(Upon enrollment)
- Patient birth place(Upon enrollment)
- Patient education(Upon enrollment)
- Patient employment(Upon enrollment)
- Patient relationship status(Upon enrollment)
- Patient neighborhood status(Upon enrollment)
- Patient food insecurity(Upon enrollment)
- Patient transportation status(Upon enrollment)
- Patient insurance(Upon enrollment)
- Patient language(Upon enrollment)
- Patient interpreter(Upon enrollment)
- Index clinic(Upon enrollment)
- Spine pain region(Upon enrollment)
- Spine pain acuity(Upon enrollment)
- Patient existing prescriptions(Upon enrollment)
- Patient new prescriptions(Upon enrollment)
- Patient referrals(Upon enrollment)
- Provider age(6-, 12-, 18-, 24-, and 30-months after start of trial)
- Provider sex(6-, 12-, 18-, 24-, and 30-months after start of trial)
- Provider race(6-, 12-, 18-, 24-, and 30-months after start of trial)
- Provider ethnicity(6-, 12-, 18-, 24-, and 30-months after start of trial)
- Provider education(6-, 12-, 18-, 24-, and 30-months after start of trial)
- Provider specialty(6-, 12-, 18-, 24-, and 30-months after start of trial)
- Provider experience(6-, 12-, 18-, 24-, and 30-months after start of trial)
- Duration of provider employment(6-, 12-, 18-, 24-, and 30-months after start of trial)
- PCP qualitative interviews(3-months after cross over to STEPPT)
- Allied provider qualitative interviews(3-months after cross over to STEPPT)
- ECN completed contacts(12-, 18-, 24-, and 30-months after start of trial)
- ECN delivery(12-, 18-, 24-, and 30-months after start of trial)
- Order Printed PT Education Materials(12-, 18-, 24-, and 30-months after start of trial)
- Order Portal PT Education Materials(12-, 18-, 24-, and 30-months after start of trial)
- Order Text PT Education Materials(12-, 18-, 24-, and 30-months after start of trial)
- Patient Portal Views(12-, 18-, 24-, and 30-months after start of trial)
- Patient Text Views(12-, 18-, 24-, and 30-months after start of trial)
研究者
Katrina Monroe
PT, PhD
San Diego State University