Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)

Official title

Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT): A Pragmatic Stepped Wedge Cluster Randomized Trial

Overview

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

• Behavioral Engagement of clinic leadership (System Intervention - Usual Care)
  No engagement of clinic leadership in promotion or monitoring of PT referral patterns among providers or PT adherence patterns among patients
• Behavioral Engagement of clinic leadership (System Intervention - STEPPT)
  Clinic Directors and Charge Nurses engage in STEPPT onboarding meeting with STEPPT Project Manager to discuss STEPPT objectives, procedures, and need for local adaptations. Medical leaders champion provider training and facilitate change in practice patterns through regularly scheduled review of trends in PT referral and adherence patterns with STEPPT Project Manager.
• Behavioral Patient Registry (System Intervention - STEPPT)
  Patients referred to physical therapy for spine pain are stratified by ethnicity. Hispanic patients are added to STEPPT Patient Registry to facilitate targeted engagement of an underserved population known to have low rates of adherence for physical therapy referrals.
• Behavioral Delivery of Patient Education Materials (System Intervention - Usual Care)
  Neck or back pain fact sheet may be manually ordered in the printed after visit summary at the discretion of the primary care physician. No automated systems for delivery of patient education materials on spine pain or physical therapy referral.
• Behavioral Delivery 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,
• Behavioral Referral Specialist Training (System Intervention - Usual Care)
  Referral Specialists trained in system-wide procedures for processing referrals, calling patients, and scheduling appointments for specialty services. Physical therapy referrals processed by a dedicated team of Physical Rehabilitation Services Referral Specialists.
• Behavioral Patient Health Navigator Training (System Intervention - STEPPT)
  Patient Health Navigators (PHNs) trained in system-wide procedures for processing referrals, calling patients, and scheduling appointments for specialty services. Additional training on patient communication and enhanced care navigation is provided to address cultural factors, individual barriers, and risk factors for non-adherence. Physical therapy referrals processed by a specially trained team of Physical Rehabilitation Services PHNs.
• Behavioral Care Navigation (System Intervention - STEPPT)
  Upon referral to PT and verification of insurance coverage, patients receive a system-generated auto-call to schedule the PT evaluation followed by up to 3 phone contact attempts by a Patient Health Navigator (PHN) to 1) deliver enhanced care navigation, and 2) schedule PT evaluation. Prior to scheduling, PHN delivers semi-scripted enhanced care navigation (ECN) with mandatory components: * Summarize benefits of PT * Emphasize importance of attending PT even if prescribed medication for tempora
• Behavioral Care navigation audit and feedback (System Intervention - STEPPT)
  Audits of fidelity to enhanced care navigation protocol using self-report checklists and review of recorded phone calls are discussed monthly with PHNs to facilitate competent and consistent delivery of enhanced care navigation for patients in STEPPT registry.
• Behavioral Primary 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)

Primary outcome measures

• Physical Therapy Referral [Time frame: Patient level: 3-months after index PCP encounter; Clinic level: 6-, 12-, 18-, and 24-months after start of trial]
• Physical Therapy Adherence [Time frame: Patient level: 6-months after index physical therapy referral; Clinic level: 6-, 12-, 18-, and 24-months after start of trial]

Secondary outcome measures (12)

• Maintenance Physical Therapy Referral [Time frame: Patient level: 3-months after index PCP encounter; Clinic level: 30-months after start of trial]
• Maintenance Physical Therapy Adherence [Time frame: Patient level: 6-months after index physical therapy referral; Clinic level: 30-months after start of trial]
• Patient age [Time frame: Upon enrollment]
• Patient sex [Time frame: Upon enrollment]
• Patient race [Time frame: Upon enrollment]
• Patient ethnicity [Time frame: Upon enrollment]
• Patient birth place [Time frame: Upon enrollment]
• Patient education [Time frame: Upon enrollment]
• Patient employment [Time frame: Upon enrollment]
• Patient relationship status [Time frame: Upon enrollment]
• Patient neighborhood status [Time frame: Upon enrollment]
• Patient food insecurity [Time frame: Upon enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Family Health Centers of San Diego — San Diego

Identifiers

NCT: NCT07290361 · HS-2023-0122 · R01MD018937

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗