Low Back Pain, Neck Pain
Conditions
Keywords
Physical therapy, Rehabilitation, Hispanic, Heatlh Services, Healthcare utilization, Federally Qualified Health Center
Brief summary
The goal of this clinical trial is to learn if a health system intervention called "Stratified Targeted Engagement from Primary Care to Physical Therapy (STEPPT)" can improve how often doctors refer Hispanic patients with spine pain to physical therapy (referral rate) and how often patients attend physical therapy after being referred (adherence rate). The main questions this study aims to answer are 1) does STEPPT improve physical therapy referral and adherence rates compared to usual care for Hispanic patients with spine pain who seek care in a Federally Qualified Health Center (FQHC) serving low income communities, and 2) how consistently do FQHC providers and staff deliver STEPPT to patients who may benefit? STEPPT will train doctors and other health care providers to educate participants on the benefits of physical therapy for spine pain and participants will receive culturally tailored handouts and videos to teach them about their spine pain and what to expect in physical therapy. Patients will also receive personalized assistance to schedule their physical therapy appointment and address potential barriers for attending the appointment.
Detailed description
This study will examine the implementation and effectiveness of STEPPT for improving access and engagement of Hispanic patients with spine pain in physical therapy (PT) services at a Federally Qualified Health Center (FQHC) serving low-income communities near the United States-Mexico border. A pragmatic hybrid type I stepped wedge cluster randomized trial (SW-CRT) will be conducted to examine the effectiveness of STEPPT for increasing rates of PT referral and adherence as a primary aim. The study will also explore implementation outcomes to better understand the context of enacting a targeted intervention to engage medically underserved populations as a secondary aim. Nine FQHC Primary Care clinics (clusters) will be randomized to three implementation steps, with three clinics allocated per step, using a covariate-constrained randomization approach. To minimize 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.
Interventions
BEHAVIORALEngagement 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
BEHAVIORALEngagement 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.
BEHAVIORALPatient 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.
BEHAVIORALDelivery 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.
BEHAVIORALDelivery of Patient Education Materials (System Intervention - STEPPT)
Automated delivery systems for patient education materials include: * 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 * Auto-order for text message with links to culturally tailored PT referral fact sheet and video upon referral to PT for spine pain * 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
BEHAVIORALReferral 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.
BEHAVIORALPatient 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.
BEHAVIORALCare 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: * Summarize benefits of PT * Emphasize importance of attending PT even if prescribed medication for temporary pain relief * Confirm patient received and reviewed educational materials. Resend materials, if needed * Address privacy concerns, if present * Address risk factors for PT non-adherence, if present: scheduling, cost, transportation barriers * Address other questions or concerns * Schedule the PT evaluation * Repeat appointment details and provide PHN contact information for additional questions
BEHAVIORALCare 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.
BEHAVIORALPrimary Care Provider training (Provider Intervention - STEPPT)
PCPs attend training with Physical Rehabilitation Services site manager on the following topics: * STEPPT objectives, procedures, and patient education materials * Referral and adherence rates for PT among Hispanic patients at FQHC clinics * Benefits of PT referral for patients with new and existing spine pain problems * Culturally responsive strategies to improve patient engagement in PT services (e.g., explanation of how PT can improve family and social role functioning)
BEHAVIORALNurse/Medical Assistant Training (Provider Intervention - STEPPT)
Nurses and MAs attend training with Physical Rehabilitation Services site manager on the following topics: * STEPPT objectives, procedures, and patient education materials * Referral and adherence rates for PT among Hispanic patients at FQHC clinics * Benefits of PT referral for patients with new and existing spine pain problems * Culturally responsive strategies to improve patient engagement in PT services (e.g., explanation of the FQHC referral process)
BEHAVIORALProvider 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.
BEHAVIORALPatient 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/Neck Pain Factsheet summarizes current evidence on etiology, prognosis, and treatment (medical and self-management) for back or neck pain. \[Available in English or Spanish language\]
BEHAVIORALPatient 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. \[All patient education materials available in English or Spanish language\]
BEHAVIORALPatient 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/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.
BEHAVIORALPatient 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.
BEHAVIORALElectronic 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: * 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. \[Eng/Span\] * 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. \[Eng/Span\]
BEHAVIORALPatient 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.
BEHAVIORALPatient 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.
BEHAVIORALCare 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.
BEHAVIORALMonitoring 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.
BEHAVIORALMonitoring of PT referral and adherence rates (System intervention - Usual Care)
PT referral and adherence rates monitored as needed by Vice President of Specialty Services.
Sponsors
San Diego State University
National Institute on Minority Health and Health Disparities (NIMHD)
Family Health Centers of San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Therapy Adherence | 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. |
| Physical Therapy Referral | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinic size | Upon crossover to STEPPT | Number of spine pain encounters during baseline period for each participating primary care clinic |
| Clinic location | Upon crossover to STEPPT | Geographic location of each participating primary care clinic |
| Clinic PT Services | Upon crossover to STEPPT | Availability of onsite physical therapy services for each participating primary care clinic |
| Provider age | 6-, 12-, 18-, 24-, and 30-months after start of trial | Ages of primary care providers employed at each participating clinic recorded in clinic operations records |
| Provider sex | 6-, 12-, 18-, 24-, and 30-months after start of trial | Sex of primary care providers employed at each participating clinic recorded in clinic operations records |
| Provider race | 6-, 12-, 18-, 24-, and 30-months after start of trial | Races of primary care providers employed at each participating clinic recorded in clinic operations records |
| Provider ethnicity | 6-, 12-, 18-, 24-, and 30-months after start of trial | Ethnicities of primary care providers employed at each participating clinic recorded in clinic operations records |
| Provider education | 6-, 12-, 18-, 24-, and 30-months after start of trial | Highest clinical degrees for primary care providers employed at participating clinics recorded in clinic operations records |
| Provider specialty | 6-, 12-, 18-, 24-, and 30-months after start of trial | Types of clinical specialties for primary care providers employed at each participating clinic recorded in clinic operations records |
| Provider experience | 6-, 12-, 18-, 24-, and 30-months after start of trial | Time elapsed between date of highest clinical degree for primary care providers at each participating clinic and date of index encounter |
| Duration of provider employment | 6-, 12-, 18-, 24-, and 30-months after start of trial | Duration of employment at federally qualified health center for primary care providers at each participating clinic recorded in clinical operations records |
| PCP frequency of PT education | Prior to training, 6-months after crossover to STEPPT | Primary care physician self-reported frequency of educating patients with spine pain about the benefits of physical therapy (never, rarely, sometimes, often, always) |
| PCP qualitative interviews | 3-months after cross over to STEPPT | 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 |
| Allied provider frequency of PT education | Prior to training, 6-months after crossover to STEPPT | Nurse and Medical Assistant self-reported frequency of educating patients about the benefits of physical therapy and referral process (never, rarely, sometimes, often, always) |
| Allied provider qualitative interviews | 3-months after cross over to STEPPT | 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 |
| Training Involvement Rating Scale (IRS) score | 12-, 18-, 24--months after start of trial | 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 |
| ECN contact attempts | 12-, 18-, 24-, and 30-months after start of trial | Proportion of Hispanic patients referred to PT with 0, 1, 2, 3, and ≥4 call attempts prior to scheduling first PT appointment or discontinuation due to failure-to-contact |
| ECN completed contacts | 12-, 18-, 24-, and 30-months after start of trial | 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 |
| ECN delivery | 12-, 18-, 24-, and 30-months after start of trial | Proportion of Hispanic patients who were successfully contacted for whom each mandatory component of enhanced care navigation was delivered |
| Order Printed PT Education Materials | 12-, 18-, 24-, and 30-months after start of trial | 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 |
| Order Portal PT Education Materials | 12-, 18-, 24-, and 30-months after start of trial | 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 |
| Order Text PT Education Materials | 12-, 18-, 24-, and 30-months after start of trial | 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 |
| Patient Portal Views | 12-, 18-, 24-, and 30-months after start of trial | 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 |
| Patient Text Views | 12-, 18-, 24-, and 30-months after start of trial | 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 |
| Maintenance Physical Therapy Referral | Patient level: 3-months after index PCP encounter; Clinic level: 30-months after start of trial | 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. |
| Maintenance Physical Therapy Adherence | Patient level: 6-months after index physical therapy referral; Clinic level: 30-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 during the maintenance phase. |
| Patient age | Upon enrollment | Patient age in years recorded in electronic health record |
| Patient sex | Upon enrollment | Patient sex at birth recorded in electronic health record |
| Patient race | Upon enrollment | Patient race recorded in electronic health record |
| Patient ethnicity | Upon enrollment | Patient ethnicity recorded in electronic health record |
| Patient birth place | Upon enrollment | Patient country of birth recorded in electronic health record |
| Patient education | Upon enrollment | Patient highest level of education recorded in electronic health record |
| Patient employment | Upon enrollment | Patient employment status recorded in electronic health record |
| Patient relationship status | Upon enrollment | Patient relationship status (e.g., married, divorced, etc.) recorded in electronic health record |
| Patient neighborhood status | Upon enrollment | Neighborhood healthy places index (HPI) score based on patient zipcode |
| Patient food insecurity | Upon enrollment | Patient food insecurity status based on PREPAR questionnaire recorded in electronic health record |
| Patient transportation status | Upon enrollment | Patient transportation status based on PRAPARE questionnaire recorded in electronic health record |
| Patient insurance | Upon enrollment | Patient insurance status (federal, private, uninsured, etc.) recorded in electronic health record |
| Patient language | Upon enrollment | Patient preferred language recorded in electronic health record |
| Patient interpreter | Upon enrollment | Patient request for interpreter during primary care visit recorded in electronic health record |
| Index clinic | Upon enrollment | Name of Federally Qualified Health Center clinic at which index encounter for spine pain occurred recorded in electronic health record |
| Spine pain region | Upon enrollment | Region of spine pain (neck, low back, both) recorded in electronic health record at index encounter |
| Spine pain acuity | Upon enrollment | New or existing spine pain problem recorded in electronic health record at index encounter |
| Patient comorbidity | Upon enrollment | Functional comorbidity index recorded in electronic health record |
| Patient new prescriptions | Upon enrollment | Type and number of new prescriptions recorded in electronic health record at index encounter |
| Patient existing prescriptions | Upon enrollment | Type and number of existing prescriptions recorded in electronic health record at index encounter |
| Patient referrals | Upon enrollment | Type and number of specialty referrals recorded in electronic health record at index encounter |
Countries
United States
Contacts
CONTACTCheenee R Real, BSN, MPH, MSOL
CONTACTShadia Assi, BS, MPH
PRINCIPAL_INVESTIGATORKatrina Monroe, PT, PhD
San Diego State University
PRINCIPAL_INVESTIGATORSara Gombatto, PT, PhD
San Diego State University Research Foundation
Outcome results
None listed