TARGET Trial Overview
The TARGET Trial is a multisite, pragmatic cluster-randomized clinical trial studying patients with acute LBP who seek care from a primary care physician and are at high risk for persistent disability. The study is designed to assess if prompt referral of patients to physical therapists with PIPT training reduces the rate of progression to chronic LBP 6-months later (primary trial outcome) and improves back-related function as compared to guideline-based primary care management. Secondary outcomes include additional healthcare resource utilization. The ongoing TARGET Trial enrolls patients from primary care clinics across multiple health systems in five geographic regions across the United States (Pittsburgh, PA; Boston, MA; Baltimore, MD; Salt Lake City, UT; and Charleston, SC) with a total planned sample size (n = 1860) that exceeds or is similar to previously completed studies [18,19,27]. The TARGET Trial is funded by the Patient Centered Outcomes Research Institute and was prospectively registered with ClinicalTrials.gov (NCT02647658) on January 4, 2016.
PIPT Training Program
Considering the pragmatic study design, several factors were considered when developing the overall structure of the PIPT training program. First, there was the need for developing a multidisciplinary training team consisting of individuals representing physical therapy and clinical psychology. Second, there was the challenge of addressing the feasibility barrier of providing training to physical therapists from different healthcare systems located across five diverse geographical regions in the United States. Finally, there was the importance of identifying facilitators for physical therapists to attend the PIPT training (e.g., cost, continuing education credit, and time commitment). Prior to trial initiation, the PIPT training program was developed, tested, and modified using an iterative process to enhance optimal effects during study training that were intended to be implemented during routine clinical practice (Figure 1).
Training Background
Development of the PIPT training program was guided by previous protocols that have tested risk stratification approaches for LBP using the STarT Back Tool [21,24]. In addition, members of the TARGET intervention team (JMB and SZG) provided PIPT training for a small scale feasibility study, training providers within a single healthcare system [26]. Key developers of the TARGET Trial PIPT training program consisted of physical therapy, clinical psychology and chiropractic providers.
Content Development
PIPT training program content development consisted of stakeholder engagement, beta testing, modification of training and confirmation of final course objectives. Each of these stages is described in greater detail below.
1. Stakeholder engagement
Prior to providing formal PIPT training, feedback and support from key stakeholders was obtained. We initially targeted a single healthcare system (University of Pittsburgh Medical Center, Centers for Rehab Services) to provide an introduction and overview of the TARGET Trial and PIPT training program. Our initial strategy included a formal task force meeting consisting of representation from TARGET Trial investigators, healthcare system executives, outpatient clinical education, senior management and clinicians. The key objective of this meeting was to prepare a task force of physical therapists within UPMC Centers for Rehab Services to become ‘clinical champions’ for implementing a standard biopsychosocial model for patients with musculoskeletal pain conditions.
2. Beta testing
Beta testing of the PIPT training program was conducted two times over a two-month period in Pittsburgh, PA and at a professional conference in National Harbor, MD. Participant feedback was collected and key suggestions were considered during subsequent modifications to the PIPT training program. One important outcome of the beta testing was that training team members identified the need for blended learning opportunities (i.e., strategic use of combined web-based and in-person content with interactive activities to enhance clinician learning), which lead to strategies for developing additional delivery platforms (e.g., PIPT website).
3. Modification of training
An iterative process of development for the PIPT training program was used, that incorporated feedback from course participants, standardized self-assessments and intervention team discussions. This lead to restructuring of the live workshop to include several interactive breakout sessions, designed for the participants to gain initial experience implementing PIPT skills. Further, video-based mock clinical scenarios suitable for live course learning opportunities, and viewing online modules for training maintenance were developed. In addition, increased time allotment and enhanced training methods were dedicated to specific PIPT content areas (e.g., patient-centered communication) based on initial feedback from participants to address barriers to clinical practice integration. These modifications are consistent with enhancements provided following pilot testing of other previous training packages [24].
4. Final course objectives
Following beta testing, feedback from participants and modification of training content and methods, final course learning objectives were finalized by the investigator team (Table 1). The overall objectives of the course were to provide participants with a summary of evidence and clinical skills necessary to support implementing PIPT principles into routine clinical practice for patients identified as being at high risk for transitioning from acute to chronic LBP. Specific learning objective included identifying relationships between biopsychosocial pain models, understanding development and maintenance of chronic LBP; understanding Cognitive-Behavioral Therapy (CBT) principles; and developing effective communication skills for patient education and PIPT implementation
5. Final course content
Detailed description of final course content is provided in Table 2. Course content was broadly described as either ‘Overview’ – providing theoretical rationale and supporting data or ‘PIPT Management’ – providing specific principles or skills with demonstration and practice. ‘PIPT Management’ content consisted of: 1) patient-centered communication; 2) pain coping skills; 3) patient education; 4) activity based intervention; 5) impairment based intervention; and 6) treatment monitoring components (Figure 2). The course content was provided in sequential order for all training sessions.
Methods of Delivery
Consistent with the pragmatic study design of the TARGET Trial, the training was designed to be easily replicated in clinical settings to promote delivery of PIPT implementation. The intention was that each site would determine specific methods favorable for that specific geographical region and health delivery system.
1. PIPT website
The TARGET Trial website [http://www.targettrial.pitt.edu/] provided an alternative delivery platform for content resources that included an overview of the TARGET Trial and provider resources (including key recommended readings). Course participants registered for formal training courses were directed to a separate PIPT website [http://www.rstce.pitt.edu/pipt/] that provided a course overview, learning objectives, education modules, and additional educational resources for patients. Twelve brief pre-course online educational modules were developed to provide necessary foundational information required to optimize the experiential nature of the 1-day live workshop. These online educational modules were designed to be viewed in sequence, with each module ranging from 8 to 22 minutes in duration. Links to voiceover PowerPoint presentations, electronic handouts and audio files were provided for each module to offer course participants different learning platform options. Physical therapists had the opportunity to obtain 2.5 hours of continuing education credit after viewing all the online modules.
2. Live workshop
Live one-day workshops were provided by at least one physical therapist and clinical psychologist up to three times at each of the five TARGET sites throughout the United States (Pittsburgh, PA; Boston, MA; Baltimore, MD; Salt Lake City, UT; and Charleston, SC). Combinations of teaching methods (Table 2) were used during each 8-hour workshop including: PowerPoint presentations; video based mock case scenarios depicting appropriate and inappropriate communication styles; and case-based role playing. To enhance clinical skills training, we utilized several structured teaching and learning strategies including: 1) instructor lead teaching on specific clinical skill; 2) instructor lead case-based role playing with mock patient; 3) course participant lead case-based role playing (i.e., breakout sessions) where smaller groups of 2 to 4 participants each assumed different stakeholder roles (e.g., patient, clinician, and observer) for a variety of clinical scenarios; and 4) class discussion to provide individual learning experience perspectives. To further enhance learning, participants were encouraged to demonstrate newly acquired clinical skills that were evaluated by instructors and other participants for real-time feedback. This case-based role playing was used to develop clinical skills involving self-reflection, motivational interviewing, pain coping skills, and activity-based interventions. Barriers and facilitators to implementing PIPT components (Figure 2) during routine clinical practice were addressed throughout the live workshops.
3. PIPT course materials
Each physical therapist was provided with course materials at the live one-day workshop that could be referenced afterwards. These materials consisted of workshop content, including specific descriptions and scenarios pertaining to PIPT interventions such as patient-centered communication, pain coping skills, patient education, activity-based intervention, impairment-based intervention, and treatment monitoring components.
Strategies to Enhance and Assess Quality and Impact of Provider Training
Establishing treatment fidelity to insure the reliability and validity of behavioral interventions has been identified as a major challenge [28,29]. The National Institutes of Health Behavior Change Consortium (NIHBCC) has developed and recently updated a treatment fidelity framework consisting of five domains (i.e., study design, training of providers, treatment delivery, treatment receipt, and treatment enactment) [28,29]. Consistent with the pragmatic nature of the TARGET Trial, balance between feasibility and obtaining comprehensive fidelity assessments was considered [30]. The PIPT program was designed to promote treatment fidelity by providing quality training that impacted key provider factors and could be replicated. Thus, we incorporated measures and strategies to enhance treatment quality and impact of training (assessment of physical therapist attitudes, beliefs and confidence; PIPT treatment checklists; and booster training).
Training quality and impact
To determine if training positively impacted physical therapist attitudes and beliefs regarding biopsychosocial treatment orientation for LBP and confidence in PIPT skill application, several statistical analyses were performed. First, paired samples t-tests were used to assess for pre to post-course changes in attitudes, beliefs, and confidence scores (described in greater detail below). Second, separate multiple regression models were used to evaluate the contribution of viewing pre-course online modules as a predictor of post-course attitudes, beliefs, and confidence scores. Third, one-way analysis of variance with Bonferroni post-hoc procedures was used to compare physical therapist attitude and belief residualized change scores between TARGET site locations to evaluate for training replicability.
Attitudes and beliefs
Physical therapist attitudes and beliefs about biomedical and biopsychosocial treatment orientations were assessed before training, immediately after completion of training, and 4-months later using the Pain Attitudes and Beliefs Scale for Physical Therapists [31,32]. The PABS-PT biomedical scale (10 items) has a potential score range from 10 to 60 and the PABS-PT biopsychosocial scale (9-items) has a potential score range from 9 to 54 with higher scores indicating increased biomedical or biopsychosocial treatment orientation depending upon the respective scale. To further explore if different delivery aspects were associated with post-course scores, we evaluated the impact of viewing pre-course online modules and pre-course scores by TARGET site location. TARGET site leaders initiated a request for follow-up assessment four months after training through email that directed course attendees to a remote website containing an electronic version of the PABS-PT with reminders being sent 2 weeks later.
Confidence in PIPT skill application
Physical therapist confidence in implementing PIPT principles was assessed before training and upon completion of training. Specifically, participants were asked to “rate your level of confidence with implementing psychological informed principles during clinical practice” using an 11-point scale (range 0 to 10) with “0” indicating “no confidence” and “10” indicating “extreme confidence”. To further explore if different delivery aspects were associated with post-course confidence scores, we evaluated the impact of viewing pre-course online modules and pre-course scores by TARGET site location. Follow-up assessments of confidence 4-months after training were not performed.
PIPT treatment checklist
To promote treatment fidelity, physical therapists were trained to indicate specific PIPT treatment content delivered during patient care by completing self-report checklists [28-30,33]. Strategies for administering checklists varied across geographical regions ranging from traditional hardcopy methods to direct entry into the electronic medical record.
Booster Training
Due to the pragmatic nature of the trial, the amount and frequency of follow-up communication and training maintenance was different in each geographical region. As a result, booster or refresher training varied extensively, with course instructors and site coordinators offering several options following the live workshop. All course participants were provided options for continued remote communication with instructors, and were encouraged to submit follow-up questions and testimonials to promote a flipped classroom learning environment. One implementation process that may be described as possible ‘best practice’ within this trial consisted of one-hour follow-up sessions provided at several clinical sites in the Salt Lake City, UT region that were focused on improving specific PIPT skills physical therapists found difficult to implement. For example, prior course participants indicated difficulty with initiating PIPT interventions, specifically related to patient-provider communication. Cognitive reassurance (engaging the patient in education) was thoroughly discussed in group settings and motivational interviewing strategies were revisited through case-based role playing using specific patient scenarios that were lead by site mentors. Another strategy in Pittsburgh, PA, Baltimore, MD, and Boston, MA regions consisted of offering brief 45-60 minute webinars where course participants were asked to submit topical questions with instructors and clinical champions providing strategies to overcome barriers to successful implementation.