TARGET Trial Overview
The Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients (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 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. Third, there was the importance of identifying facilitators for physical therapists to attend the PIPT training (e.g., cost, continuing education credit, and time commitment). Finally, the potential impact of discussions between physical therapists was not as concerning based on the cluster-randomized clinical trial study design, which decreased likelihood for contamination across clinical sites. 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 that consisted 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
Similar training programs have undergone beta testing to obtain critical feedback for guiding modification and prior to providing actual training in preparation for trial participation (21, 24). Beta testing of the PIPT training program was provided for two separate cohorts of licensed physical therapists over a two-month period in Pittsburgh, PA (n = 40) and at a professional conference in National Harbor, MD (n = 15). Participant feedback was collected through discussion and brief surveys with key suggestions considered during subsequent modifications to the PIPT training program. One important outcome of the beta testing provided by course participants was 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 led to strategies for developing additional and previously recommended (28) 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 beta course participants, standardized self-assessments and intervention team discussions. This led to restructuring of the live workshop to include: 1) several interactive breakout sessions, designed for the participants to gain initial experience implementing PIPT skills; 2) video-based mock clinical scenarios suitable for live course learning opportunities; 3) development of online video modules for training maintenance; and 4) increased time allotment and enhanced patient-centered communication training methods dedicated 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). Collectively, the overall objectives of the PIPT training program 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. Methods of delivery (described below) were intended to promote a blended learning (i.e., flipped classroom) learning environment with instructional strategies guided by specific learning objectives (29, 30). Flipped classroom pedagogy principles included as part of the PIPT training program included: flexible learning, improved preparation for the live workshop, self-reflection, peer-learning and enhanced rapport with instructors.
5. Final course content
A description of the final course content is provided in Table 2. Course content was broadly described as either ‘Overview’ – providing rationale and supporting data for PIPT approach, 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 augment delivery of PIPT implementation. Flipped classroom instructional methods were integrated to enhance preparation for the live workshop, with the intention 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 and promote a flipped classroom learning model. These online educational modules were designed to be viewed in sequence, with each module ranging from 8 to 22 minutes in duration (total viewing time: 150 minutes). 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. Viewing online video modules was highly recommended prior to attending the live workshop, however we did not monitor everyone who accessed the website. Physical therapists seeking continuing education credit were required to complete a quiz after each online module, thereby providing a method to monitor online attendance certificate of completion eligibility. In situations where physical therapists were not seeking continuing education credit (as not required in all states), quizzes were not administered and there was no method to objectively monitor online attendance.
2. Live workshop
All sites participating in the TARGET Trial had practicing physical therapists that would deliver PIPT at a local clinic were required to host live workshops as part of their site participation requirement. However, our ability to monitor which specific physical therapists attended and where they were practicing in a given site was limited as registration processes varied across TARGET site locations. 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 led teaching on specific clinical skills; 2) instructor led case-based role playing with mock patient; 3) course participant led 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 (31, 32). 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) (31, 32). Consistent with the pragmatic nature of the TARGET Trial, balance between feasibility and obtaining comprehensive fidelity assessments was considered (33). 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 strategies (PIPT treatment checklist and booster training) and measures (physical therapist attitudes, beliefs and confidence, described in greater detail below) to enhance treatment quality and impact of training.
Strategies to enhance treatment quality
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 (31-34). 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 that physical therapists found difficult to implement. For example, prior to the 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 led 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.
Measures to assess training impact
Physical therapists that attended the live work shop were administered questionnaires to assess attitudes, beliefs and confidence (described below). Course instructors did not provide any instruction or advice for how to respond to individual questionnaire items.
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 (PABS-PT) (35, 36). The PABS-PT consists of 19 items about treatment orientation that are rated using a 6-point Likert scale ranging from “totally disagree” to “totally agree”. 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. 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 (same day). 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”.
Evaluation of PIPT Training Program
We performed several descriptive statistics on the physical therapists who participated in our PIPT training workshop at the five trial sites. A total of four hundred and seventy one outpatient physical therapists attended at least one live workshop and completed pre-training questionnaires. Means and standard deviations were calculated for available continuous variables (i.e., age, years in practice, PABS-PT and confidence scores) for the entire study sample by each TARGET site (Table 3). Paired samples t-tests were used to assess for pre to post-course changes in the scores derived from the PABS-PT (biomedical and behavioral scale) and confidence in applying PIPT questionnaires. Then, three separate multiple regression models were used to explore the contribution of TARGET site location and viewing pre-course online video modules as predictors of post-course scores. For each model, Block 1 accounted for pre-training PABS-PT or confidence scores depending upon the outcome of interest; Block 2 added TARGET site location to Block 1; and Block 3 added self-report response to question about viewing pre-course video modules (Yes or No) to Block 2. Finally, one-way analysis of variance with Bonferroni post-hoc procedures was used to compare physical therapist PABS-PT (biomedical and behavioral scale) and confidence residualized change scores between TARGET site locations to evaluate for training replicability.