Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Cluster Randomized Controlled Trial
Phase: NA
Conditions: Low Back Pain
Sponsor: University of Pittsburgh

Study Protocol 
 
 
Official Title:  Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: 
A Multi-Site Pragmatic Cluster Randomized Controlled Trial 
 
ClinicalTrials.gov ID (NCT number):  NCT02647658 
 
Protocol Date:  9/1/2018 

 
 
Targeted Interventions to Prevent Chronic Low Back 
Pain in High Risk Patients: A Multi-Site Pragmatic RCT 
(TARGET Trial) 
 
Protocol  
Version 3.0; 09/01/2018 
 
 
 
 
 
 
Principal Investigators: 
Anthony Delitto, PhD, PT, FAPTA 
Professor and Dean 
University of Pittsburgh School of Health and Rehabilitation Sciences 
 
Robert Saper, MD, MPH 
Professor of Family Medicine 
Boston University School of Medicine 
Director of Integrative Medicine 
Boston Medical Center 
  
 
 
 
 
 
This project is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award 
(PCS-1402-10867) 
PCORnet Study Identification Number: C11-2016-0001 

 
 
Table of contents 
Synopsis .................................................................................................................................... 1 
1 
Study objectives .................................................................................................................. 3 
1.1 
Primary objective ......................................................................................................... 3 
1.2 
Secondary objectives ................................................................................................... 3 
2 
Background ......................................................................................................................... 5 
2.1 
Background on acute LBP ........................................................................................... 5 
2.2 
Gaps in evidence ......................................................................................................... 6 
2.3 
Study rationale ............................................................................................................. 8 
3 
Study design ......................................................................................................................14 
3.1 
Primary, secondary and additional study designs .......................................................14 
3.2 
Randomization ............................................................................................................15 
3.3 
Primary, secondary, and additional study outcomes ...................................................15 
3.4 
Study population and sites ..........................................................................................16 
4 
Selection and enrollment of participants .............................................................................17 
4.1 
Inclusion criteria ..........................................................................................................17 
4.2 
Exclusion criteria .........................................................................................................17 
4.3 
Study enrollment procedures ......................................................................................17 
5 
Study interventions ............................................................................................................19 
5.1 
Interventions, administration, and duration ..................................................................19 
5.2 
Handling of study interventions ...................................................................................20 
5.3 
Concomitant interventions ...........................................................................................21 
5.4 
Adherence assessment ..............................................................................................21 
6 
Study procedures ...............................................................................................................22 
6.1 
Schedule of evaluations ..............................................................................................22 
6.2 
Description of evaluations ...........................................................................................22 
7 
Safety assessments ...........................................................................................................24 
8 
Intervention discontinuation ...............................................................................................24 
9 
Statistical considerations ....................................................................................................24 
9.1 
General design issues ................................................................................................24 
9.2 
Randomization, sample size and power – RCT cohort ................................................26 
9.3 
Randomization, sample size and power – observational cohort ..................................27 

 
 
9.4 
Outcomes ...................................................................................................................28 
9.5 
Data analyses .............................................................................................................28 
10 
Data collection and quality assurance ............................................................................30 
10.1 
Data collection ............................................................................................................30 
10.2 
Data management ......................................................................................................31 
10.3 
Quality assurance .......................................................................................................31 
11 
Participants rights and confidentiality ..............................................................................33 
11.1 
Institutional Review Board (IRB) review ......................................................................33 
11.2 
Informed consent scripts .............................................................................................33 
11.3 
Participant confidentiality ............................................................................................33 
11.4 
Study discontinuation ..................................................................................................33 
12 
Committees ....................................................................................................................34 
13 
Publication of research findings ......................................................................................34 
14 
References .....................................................................................................................35 
15 
Appendix 1: Chronic LBP Questionnaire .........................................................................40 
16 
Appendix 2: STarT Back Tool .........................................................................................41 
17 
Appendix 3: Oswestry LBP Questionnaire ......................................................................42 
18 
Appendix 4: Physical Therapist Checklist .......................................................................43 
19 
Appendix 5: Flow diagram for each regional site ............................................................44 
20 
Appendix 6: Data from electronic medical record ............................................................45 
21 
Appendix 7: Letters from health system to eligible patients (30 days) .............................46 
Appendix 7 (continued): Letters from health system to eligible patients (90 days) .........47 
Appendix 7 (continued): Letters from health system to eligible patients (150 days) .......48 
22 
Appendix 8: Consent for 6-month assessment ...............................................................49 
23 
Appendix 9: Participating study sites and investigators ...................................................50 
 
 

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Synopsis 
Study title: Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A 
Multi-Site Pragmatic RCT (TARGET Trial) 
Objectives:  
Low back pain (LBP) is one of the most prevalent and potentially disabling conditions for which 
people seek health care. Patients, providers, and payers are in agreement that greater effort 
needs to be directed toward prevention of the transition from acute to chronic LBP. Chronic LBP 
is painful, disabling and expensive (from a patient’s perspective), extremely difficult to manage 
(from a provider’s perspective), fraught with inefficiencies including unnecessary exposure to 
expensive tests and risky procedures (from a payer’s perspective), and may contribute to opioid 
dependence and abuse (from society’s perspective). With the majority of patients who 
experience acute LBP seeking care from their primary care physician (PCP), this study will 
compare common, pragmatic, evidence-based, and patient-centered approaches emanating 
from the PCP environment to reduce the proportion of people with acute LBP who transition to 
chronic LBP and improve functional abilities. 
The research question to be addressed with the present study is:  
For patients with acute LBP deemed high risk to transition to chronic LBP, does 
prompt referral to psychologically informed physical therapy (PIPT) reduce the rate of 
transition to chronic LBP and improve functional abilities? 
To answer this question, we will compare: 
1. A Guideline-Based Care (GBC) arm (comparator arm) in which management decisions 
are made between PCPs and patients with the guidance of best evidence but with no 
specific directives; and 
2. A Guideline-Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) 
arm (intervention arm) in which PCP care is enhanced with a prompt referral to physical 
therapy (PT) that includes psychologically informed coaching directed towards education 
and reduced fear of movement. 
Specific aims: 
Primary Aims:  For patients with acute LBP deemed high risk to transition to chronic LBP, 
determine the effect of prompt referral to PIPT in (1) preventing transition to chronic LBP and (2) 
improving functional abilities. 
Secondary Aims: (1) Measure use of medical resources for treatment of LBP for those patients 
categorized as high risk at presentation; and (2) Describe rates of transition from acute to 
chronic LBP, functional ability, and use of medical resources for patients categorized as low or 
medium risk at presentation to their PCP. 
Hypotheses: The combined GBC+PIPT intervention arm for high risk patients will be more 
effective than the GBC comparator arm alone in (1) preventing patients with acute LBP from 
developing chronic LBP, (2) improving functional outcomes, and (3) reducing medical resource 
utilization for the treatment of LBP. 

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Design and outcomes:  
The primary randomized controlled trial (RCT) cohort study is a multi-site cluster RCT 
comparing GBC versus GBC+PIPT for patients with acute LBP at high risk for transition to 
chronic LBP, as determined by the STarT Back Screening Tool. A secondary, prospective, 
observational cohort study will be conducted for those patients presenting with acute LBP who 
are at low or medium risk for chronic LBP as measured with the STarT Back Tool. 
The STarT Back Tool is a 9-item, validated questionnaire for use in the PCP setting to screen 
patients with acute LBP for prognostic indicators of transition to chronic LBP. The tool groups 
patients into low, medium, and high risk categories. Though the tool was developed and tested 
with European samples, there is emerging evidence to support its use in the US. Recruitment 
will include a minimum of 12 PCP clinics within each of five geographical areas (Pittsburgh, PA; 
Boston, MA; Baltimore, MD; Charleston, SC; Salt Lake City, UT). Each PCP clinic will be cluster 
randomized to one of two arms of the trial.  
The primary outcome measures of the study are the presence or absence of chronic LBP and 
functional ability, determined by the Oswestry Low Back Pain Disability Index (Oswestry), at 6 
months in the high risk group. A secondary outcome measure is medical resource utilization 
related to LBP (e.g., imaging, epidural steroid injections, prescribed medications, surgery) 
determined through electronic medical record (EMR) data. 
Interventions and duration: 
This research study is built upon a quality improvement (QI) initiative that includes 1) collection 
of patient-reported outcomes in all primary care settings and 2) prompt referral to PIPT for 
patients with high risk acute LBP in the intervention settings. All PCPs part of the initiative will 
receive a primer on current evidence-based clinical care guidelines for the treatment of acute 
LBP. All PCP practices will receive QI instruction on how to collect data for the Chronic LBP 
Questionnaire, the Oswestry LBP Questionnaire, and the STarT Back Tool, which will be given 
to clinicians and PCPs through the EMR. Clinicians in the intervention settings will also receive 
QI instruction and EMR tools to refer patients with high risk acute LBP to a PT practice where 
physical therapists have been trained in PIPT methods. Patients in the GBC comparator arm will 
receive care from their PCP based on best evidence but with no specific directives or prompts 
for referrals. Recruiting for participation in the research study will occur at each of the five sites 
for 15-26 months. 
Sample size and population: 
Plans are to enroll 1,860 high risk patients for the RCT. The observational cohort will consist of 
6,900 low and medium risk patients. Both groups will be followed for 12 months. 
 
 

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1 Study objectives 
The target population for this study is adult patients who present to PCPs (i.e., internal 
medicine, family practice, and geriatric medicine physicians) to receive care for back pain 
during the primary care clinic visit. To distinguish “acute” versus “chronic” LBP, a 2-
question screen based on criteria developed by the NIH Research Task Force on Chronic 
Low Back Pain will be used: 1) How long has low back pain interfered with your ability to do 
regular daily activities? 2) Think only about the past 6 months.  How often has low back 
pain interfered with your ability to do regular daily activities? A response of “more than 
three months” to question 1, and a response of “half the days or more than half the days” to 
question 2 will define chronic LBP. By definition, all other patients will be defined as having 
acute LBP. Patients will be excluded who have medical contraindications to PT (“red flags”) 
based on the judgement of the PCP as documented in the EMR. 
1.1 Primary objective  
The primary aims (PA1 and PA2) of this pragmatic clustered RCT and the primary 
hypotheses (H1 and H2) are: 
1.1.1 PA1: In patients with acute LBP who are deemed “high risk” for transition to 
chronic (RCT cohort), two study arm treatments will be compared, 1) GBC and 
2) GBC+PIPT, and the proportion of this cohort that transition to chronic LBP at 
the 6-month assessment. 
1.1.2 H1: GBC+PIPT will be more effective than GBC alone for preventing patients 
with high risk acute LBP from developing chronic LBP. 
1.1.3 PA2: Compare between the two study arms LBP-related function (e.g., lifting, 
walking, sleeping) for high risk patients using the Oswestry at 6 months. 
1.1.4 H2: GBC+PIPT will be more effective than GBC alone for improving functional 
outcomes for patients with high risk acute LBP. 
1.2 Secondary objectives 
Secondary aims (SA) and relevant hypotheses are: 
1.2.1 SA3: Compare between the two study arms acute LBP-related medical 
resource utilization (e.g., imaging, epidural steroid injections, opioids) for high 
risk patients. 
1.2.2 H3: GBC+PIPT will be more effective than GBC alone for reducing LBP-related 
medical resource utilization for patients with high risk acute LBP. 
1.2.3 SA4: Follow patients with acute LBP who are deemed “low and medium risk” in 
an observational cohort to determine the proportion that transitions to chronic 
LBP at 6 months, assess functional outcomes at 6 months, and measure LBP-
related medical resource utilization at 12 months.  

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1.2.4 SA5: Conduct subgroup analyses for PA1-2 and SA3-4 on patients with lower 
socioeconomic status (using Medicaid or no insurance as a proxy) and the co-
morbid conditions of smoking, depression, and obesity. 
1.2.5 H5: GBC+PIPT will have lower transition to chronic LBP and will be more 
effective than GBC alone for improving functional outcomes and reducing LBP-
related medical resource utilization for the subgroup of patients with depression 
or low socioeconomic status. Because the interventions being studied do not 
specifically target obesity and smoking, and the influence of smoking and 
obesity on the progression of acute to chronic LBP is uncertain, group x obesity 
or smoking interactions are not expected. 
 
 
 

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2 Background 
2.1 Background on acute LBP 
2.1.1 LBP is highly prevalent. Low back pain (LBP) is the most common type of 
pain and the second most common reason for doctor visits in the United 
States.1 More than 26 million Americans age 20-64 have frequent LBP2 and 
nearly 2.5 million Americans are disabled by LBP, 1.2 million permanently.3 Up 
to 80% of United States adults will experience at least one episode of LBP in 
their lifetime4,5 and approximately 25% report experiencing an episode of LBP 
during the previous month.6 Chronic LBP affects an estimated 5-10% of United 
States adults.7 
2.1.2 Acute LBP frequently transitions to chronic LBP. The prognosis of acute 
LBP is generally considered good, with a prevailing view that spontaneous 
recovery occurs within six weeks.8 However, epidemiologic studies in primary 
care settings report that only 60% to 75% of patients improve within one 
month,9 and at three months, 27% are completely better, 28% improved, 30% 
have no change, and 14% are worse or much worse.10 Additionally, 
recurrences are common (up to 54% in first 6 months) and 19% of patients can 
still be symptomatic at 2 years.11 Patients, providers, and payers are in 
agreement that greater effort needs to be directed toward preventing the 
transition from acute to chronic LBP. Once LBP becomes a chronic condition, it 
is painful, disabling, expensive, extremely difficult to manage, and fraught with 
health system inefficiencies. 
2.1.3 LBP significantly reduces quality of life. LBP is associated with limitations in 
physical function, work, and school activities.12 It can impact the ability and 
desire to engage in social activities, resulting in social isolation, marital conflict, 
and feelings of resentment and dejection in friends or family members.13 Over 
50% of adults with chronic LBP report difficulties with basic functions such as 
movement or cognition, and 55% report difficulties with complex actions such 
as self-care or work activities.1 LBP is also the most common cause of lost 
work productivity and is second only to upper respiratory complaints as a 
reason for lost work time.12 
2.1.4 LBP results in high medical resource utilization. LBP accounts for 34 
million office visits annually to family physicians and primary care internists.14 
Annual direct costs for LBP care in the US are more than $50 billion.15 Indirect 
costs for chronic LBP (predominantly change in work productivity in most 
populations)16 are large and estimated to be greater than direct costs.17-22 Back 
pain patients incur up to 75% more medical expenditures than patients without 
back pain.23,24 Back injury is the leading and most expensive cause of workers’ 
compensation claims.25,26 
2.1.5 Opioid prescribing for LBP is contributing to the opioid abuse problem. 
Opioids are increasingly prescribed by PCPs for patients with LBP. The 

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evidence for opioid treatment for chronic LBP is weak but suggests modest 
clinical improvement in pain control as compared to controls, with no evidence 
of functional or quality of life improvement.27,28 There are numerous concerns 
associated with the increased prescribing of these medications, including 
addiction and opioid-induced overdose. Since the 1980s, opioid prescribing 
and unintentional opioid overdose deaths have increased four-fold, and 
substance abuse treatment admissions for prescription opioid addiction have 
increased five-fold.29,30 In 2010, opioids were the leading cause of prescription 
drug overdose death in the US, responsible for 16,651 deaths.31 
2.1.6 Health disparities are associated with LBP. LBP disproportionately impacts 
racial and ethnic minorities.7,32,33 Medical expenditures for LBP in minorities are 
30% lower than for whites.15 Minorities with LBP receive less patient 
education,14 analgesic prescriptions,14,34 back surgery,35 specialty referrals,36 
and intensive rehabilitation for occupational back injuries.37 
2.2 Gaps in evidence 
2.2.1 Effective patient-centered strategies to prevent acute LBP from becoming 
chronic are unknown. The most comprehensive systematic review of practice 
guidelines to date, issued in 2007 by the American College of Physicians and 
the American Pain Society in Annals of Internal Medicine, found there were 
insufficient data to support any specific approach to prevent the transition from 
acute to chronic LBP.38 An exhaustive review of the literature published after 
11/1/2006 (search terms clinical trials, back pain, chronic, acute, prospective, 
prognosis) was conducted that yielded 96 citations. The titles and abstracts 
were reviewed to identify 59 papers that were reviewed more thoroughly. Of 
these, 23 attempted to either predict the transition from acute to chronic pain 
and/or follow patients through the transition. However, no definitive prospective 
clinical trials were identified comparing different patient-oriented interventions 
with sufficient long-term follow-up to determine effectiveness for the prevention 
of the transition from acute to chronic LBP. 
2.2.2 The rate of transition from acute to chronic LBP is not well characterized. 
The societal burden of chronic LBP, which is attributed to a small minority of 
patients with LBP, is well supported.39 Despite numerous studies documenting 
epidemiological features of LBP, there is little discrete information about 
chronic LBP and its relationship to acute LBP,26 including more precise data 
concerning the rate of transition from acute to chronic. Estimated rates of 
transition vary widely from 5-33%.8-11,40 European studies41 of a stratified 
approach similar to our proposed intervention demonstrated improvement in 
patient-centered outcomes, such as back pain-related function (e.g., 
improvements in walking, climbing stairs, carrying groceries, sexual function), 
pain intensity, patient satisfaction, sleep, and mood. Reduced patient exposure 
to expensive and possibly risky tests and procedures was also found. However, 

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the European studies did not assess the potential for reducing the transition 
from acute to chronic. 
2.2.3 There is a historical lack of a consensus definition of chronic LBP. A 
contributor to the lack of strategies to prevent chronic LBP and characterization 
of chronic LBP is the lack of definition of chronic LBP, ranging from 7-12 
weeks.42 However, the 2014 NIH Research Task Force on Chronic Low Back 
Pain addressed this issue by developing a straightforward two-question 
approach to distinguish chronic from acute LBP.42 
2.2.4 Deficiency of LBP guideline implementation at the PCP level. Various 
clinical practice guidelines for the management of LBP have been developed 
with the goal of enhancing the effectiveness and efficiency of care.8,43 The 
aforementioned 2007 Annals of Internal Medicine review recommended 
patients with acute nonspecific LBP should be provided with generic treatment 
that emphasizes spontaneous recovery facilitated through low-impact exercise 
and a prompt return to normal activity, at the same time discouraging early 
diagnostic (e.g., MRI) and intervention (e.g., epidural steroid injections, 
surgery) procedures.44 However, systematic reviews of adherence to guidelines 
suggest that, in general, adherence is incomplete and slow45 and only 
minimally influenced by printed educational materials and other passive 
diffusion techniques.46 
2.2.5 Primary care LBP clinical guidelines do not always align with 
psychosocial factors related to LBP. All LBP guidelines promote early 
activation (e.g., encouragement to quickly return to normal activities). Yet some 
patients overtly avoid physical activity during an episode of LBP because of 
fear of aggravating their condition (“fear avoidance”), a disproportionately 
pessimistic outlook (“catastrophizing”), and depression.47 Fear avoidance, 
catastrophizing, and depression are generally recognized as major obstacles to 
recovery.48 Recent work largely carried out in European countries has 
demonstrated that a stratified approach using prognostic screening tools to 
assess both physical and psychosocial factors, coupled with matched 
intervention pathways, can have important implications for better managing 
acute LBP in primary care settings.41,49,50  
2.2.6 Deficiency of LBP guideline implementation in PT care. Guideline 
adherence in PT environments remains at a persistently low level and variation 
is poorly understood,51-55 despite the existence of accepted guidelines and 
reasonable evidence for effectiveness of LBP treatments.56 Of particular 
relevance to the proposed study is the emerging evidence in PT that supports 
the use of psychologically informed physical therapy for patients with 
psychosocial characteristics associated with transition to chronic LBP. 
Combined therapies for those individuals, who can be identified via a brief 
screening procedure, are recommended in current PT guidelines.56 

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2.2.7 Patient preferences do not always align with LBP guidelines. A systematic 
review of qualitative and quantitative studies57 verified that patients with LBP 
expect: 1) a physical exam, 2) a diagnosis and explanation of the cause of their 
pain, 3) information and instructions on self-care, and 4) pain relief. Patients 
also expect health care providers to confirm that their pain is real, listen to and 
respect their views and treatment preferences, and include them in decision 
making. Patients can become impatient with “wait and see” approaches, which 
are common in guideline recommendations, and will instead request more 
biomedical explanations for their symptoms.58 In response to patient desires 
and demands, PCPs will commonly order expensive diagnostic tests,57 invasive 
therapies, or referrals to specialists that include significant out-of-pocket 
expense or expose patients to unnecessary risk. For example, between 2000 
and 2002, almost 61% of Pennsylvania Medicare cases received an MRI for 
nonspecific LBP even though there were no indicators for the procedure, as 
specified by the U.S. Department of Health and Human Services Agency for 
Health Care Policy and Research guidelines for LBP.59 Opioid analgesics, 
epidural steroid injections, and spine surgery referrals are also commonly 
recommended by PCPs for nonspecific LBP despite lack of strong evidence 
supporting effectiveness.60  
2.2.8 PCP constraints do not align with LBP guidelines, Though guideline-based 
approaches to LBP do not appear to be uniformly embraced by PCPs,61 the 
non-adherence to guidelines may have less to do with PCP knowledge gaps 
and be more related to time constraints. Stakeholder engagement discussions 
with PCPs, confirmed by the literature,62 identify time constraints common to 
PCP practice in the US as the major barrier in addressing patient concerns. 
Given the prevalence of LBP in primary care settings, the cumulative time for 
communication and education - specifically inquiring about patients' 
expectations, providing opportunities to correct misperceptions, explaining the 
natural history of LBP and the rationale for test and treatment decisions - 
quickly becomes overburdening in a busy PCP clinic. A quote heard in more 
than one PCP stakeholder engagement session was, “It’s far easier to just 
order the MRI and prescribe medications.” Our own patient stakeholders 
uniformly comment that they also are frustrated by the lack of time their PCP 
has to address their LBP, especially when it is above and beyond multiple other 
chronic issues, such as diabetes and hypertension, that all need to be 
addressed in a 15-minute visit. Patients also expressed dissatisfaction with a 
medication-only approach. A common sentiment of our patients was, “All the 
doctor wants to do is prescribe drugs.” 
2.3 Study rationale 
This study will assess whether the stratified approach using PIPT matched to acute 
LBP patients at high risk for poor outcomes 1) is effective in the US; 2) has the 
potential to prevent patients from transitioning to chronic LBP; and 3) reduces patient 
exposure to unnecessary, expensive, and potentially harmful tests (e.g., MRIs), 

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medications (e.g., opioids), and procedures (e.g., epidural steroid injections). The 
research will provide guidance to patients, primary care providers, clinics, hospital 
systems, insurers, payers, and professional organizations responsible for clinical 
practice guidelines and dissemination regarding the following health decision: Should 
prompt referral to evidence-based psychologically informed physical therapy be 
strongly recommended for high risk patients presenting with acute LBP? 
2.3.1 Pragmatic clinical trial design: This study is focused on whether the stratified 
approach with PIPT is feasible and effective in a primary care clinical setting. 
Consequently, based on the work of Thorpe et al64 and Loudon et al,63 the 
study intentionally incorporates the Pragmatic Explanatory Continuum Indicator 
Summary tool, version 2 (PRECIS-2), nine domains to achieve a pragmatic 
approach. The nine domains are eligibility criteria, recruitment, setting, 
organization, delivery, adherence, follow-up, primary outcome, and primary 
analysis. These domains will be referenced in the remainder of the document 
as specifics of the design, interventions, and analysis are presented. 
2.3.2 Subjects are patients with acute LBP that present at primary care 
practices: Subjects for this study will be adult patients who present to PCPs 
(i.e., internal medicine, family practice, and geriatric medicine physicians) to 
receive care for back pain during a primary care clinic visit. Testing this 
approach in primary care environments was chosen because many patients in 
the US prefer accessing their PCP for the majority of their health problems, 
including LBP. This setting is consistent with the PRECIS-2 pragmatic setting 
domain. Subjects will then be identified as acute or chronic using a modified 
version of the chronic LBP definition recently created by the NIH Research 
Task Force on Chronic Low Back Pain.42  
2.3.3 Acute LBP interventions based on a stratified approach: After identification 
as an acute LBP patient, the STarT Back Tool will be administered, and the 
resulting scores will stratify patients as low, medium, or high risk for transition 
to chronic LBP. Patients identified as high risk are patients who would likely 
benefit from increased education and attention due to greater perceived pain, 
poor physical functioning, maladaptive coping behaviors (catastrophizing, fear 
avoidance), and comorbid depression and anxiety.65 PCPs can then efficiently 
target interventions for these patients. 
This stratified approach to treating LBP in the primary care environment is 
largely based on compelling effectiveness data from European investigators.41 
Foster’s study in UK family practices used the STarT Back Tool to stratify acute 
LBP patients into 3 risk categories: high, medium, low.50 In the development of 
the STarT Back Tool, patients were a significant part of a clinical advisory 
panel that reviewed the list of potential constructs and chose the final ones. 
Patient acceptability of the tool was also assessed using a sample of back pain 
patients consulting primary care. Patients need 2-3 minutes to answer the 9 
patient-centered, yes/no questions. Those patients determined by the STarT 

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Back Tool as being high risk had higher levels of fear avoidance, 
catastrophizing, mood disturbance, and perceived pain. They were deemed 
high risk for worse outcomes and were referred to psychologically informed PT 
to address physical symptoms and function, and also psychosocial obstacles to 
recovery.41,49,50 Compared to usual care, the high risk group referred to PT 
experienced significantly improved back function, less time off work, and less 
expensive care.41,49,50 Though the stratified approach with targeted intervention 
is beginning to be evaluated in the US, published studies based in US 
healthcare systems have thus far been limited in scope, observational in 
nature, and have not prospectively measured the transition from acute to 
chronic LBP.  
2.3.4 Pragmatic RCT comparing GBC and GBC+PIPT interventions: This 
pragmatic RCT will have two study arms for treating patients identified as high 
risk for transitioning to chronic LBP: 1) GBC arm in which management 
decisions are made between PCPs and patients with the guidance of best 
evidence but with no specific directives, and 2) GBC+PIPT in which the PCP 
care includes directives for an immediate referral of high risk patients to a 
standardized regime of PIPT directed towards education and reduced fear of 
movement. By assessing the comparative effectiveness of GBC versus 
GBC+PIPT in an RCT conducted in the US, patients and their PCPs will be 
better able to judge the potential effectiveness of prompt referral to PIPT in 
reducing the risk of acute LBP leading to persistent disability from chronic LBP. 
Based on stakeholder feedback, an RCT design was chosen because its 
results will be more compelling and definitive, more generalizable with a 
greater degree of certainty that could lead to changes in provider behavior and 
payers’ benefit design. This study’s primary outcome (PRECIS-2 domain) of 
rate of transition from acute LBP to chronic LBP for high risk patients receiving 
PIPT is directly relevant to high risk acute LBP patients because it will address 
their specific psychosocial conditions and improve outcomes. Furthermore, it 
will provide PCPs with specific techniques for caring for these patients. 
2.3.5 Rationale for GBC comparator arm: Based on guidance from Thompson and 
Schoenfeld,66 a comparator arm (GBC in this case) is justified because: 1) the 
research question is to compare an evidence-based “strategy” against 
guideline-informed care and 2) both approaches are considered prudent and 
good care for the target population. The “strategy” (GBC+PIPT) is an approach 
designed to match patients with LBP stratified to high risk to the PIPT regimen, 
which has been shown to be effective.41,49,50 In the GBC arm, PCPs will be 
given a primer on guidelines for LBP and have available through the EMR 
information about the patients’ chronic versus acute status, functional 
limitations (Oswestry), and risk level (STarT Back). However, a PT referral will 
not be automatically generated and the PCP will have the freedom to treat high 
risk patients according to their individual clinical judgment.  

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Furthermore, there are pragmatic reasons to include the GBC arm. Primary 
care for low back pain is highly variable with little evidence thus far of adequate 
translation of evidence-based practice (EBP) guidelines to routine clinical care. 
Until recently, most approaches to EBP uptake in primary care have relied 
solely on passive diffusion (e.g., “publish it and they will come”) approaches. 
With health care reform and increasing emphasis on quality, however, there 
are other factors that may accelerate clinicians’ adoption of EBP approaches. 
At the University of Pittsburgh Medical Center (UPMC), Intermountain 
Healthcare, and Boston Medical Center, shared savings programs and other 
system-wide quality initiatives have been implemented, all of which may result 
in better uptake of best care standards. Provider stakeholders interviewed all 
agreed that LBP represents an area of concern within their systems and 
predicted that it will be a target of such initiatives. Given these probable 
initiatives within the study sites, it is essential to have a comparator arm to the 
study as an accurate comparator of real-life primary care for LBP. In addition, a 
number of the primary care stakeholders interviewed do not routinely refer to 
physical therapists. However, they are willing to go along with the 
randomization assignment and will comply with either arm of the trial. Although 
some degree of crossover is anticipated (i.e., patients assigned to GBC will be 
referred to PT), it is highly likely to be less than patients from GBC+PIPT sites. 
Moreover, this crossover will be tracked through the EMR.  
2.3.6 Rationale for GBC+PIPT intervention: When familiarized with the studies 
from Europe on the STarT Back approach, stakeholders and investigators were 
intrigued with its sensibility and, most importantly, its positive results with 
regard to outcomes, such as less pain, improved back function, and reduced 
exposure to tests and measures. The probability of transitioning to chronic LBP 
relative to GBC will be measured, which was not measured by the European 
studies. Though all interviewed stakeholders agreed and understood the lack of 
generalizability to the US health care system, all were confident that the 
approach could be easily replicated in the US with some caveats. Although PT 
is a covered benefit common to virtually all US payers, the size, scope, and 
cost of US PT benefits are often distinctly different than in Europe (i.e., less 
care with greater co-payments). These concerns were quickly brought forth for 
discussion by patient stakeholders and PCP providers whose clientele are 
under-served populations.  
2.3.7 Quality improvement initiatives: This study is dependent on the 
implementation of two QI initiatives. First, all sites and PCP clinics involved in 
this study will implement tools (e.g., patient portals, tablet computers, EMR 
upgrades) for the collection of patient-reported outcomes. They will also put in 
place QI training programs for staff and clinicians to learn how to collect 
patient-reported outcomes into the EMR. Finally, they will create monitoring 
reports that track performance of the PCP clinics in capturing patient-reported 
outcomes. Second, all intervention sites will implement tools (e.g., EMR 

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notifications, order sets, electronic orders, letters) to alert clinicians and PCPs 
of patients with high risk acute LBP. They will also conduct QI training 
programs on when and how to refer patients to PIPT. Monitoring reports for 
referral to PIPT will also be implemented to track performance on this QI 
initiative. 
2.3.8 Generalizability of subject eligibility: This study will use broad inclusion 
criteria (age 18 or older, primary complaint of back pain) and limited exclusion 
criteria (“red flag” signs and symptoms of medical contraindications to physical 
therapy based on the judgement of the PCP as documented in the EMR). The 
study will exclude patients less than 18 years of age based on feedback from 
primary care stakeholders who stated that patients younger than 18 commonly 
have their care managed by pediatricians, and LBP in adolescents is typically 
managed differently than adult LBP. Selection of the exclusion criteria was 
determined based on concerns for patient safety. In keeping with the pragmatic 
nature of the trial and the PRECIS-2 domain of eligibility, it will: 1) have no 
upper age limit; 2) include women who are pregnant; and 3) include people 
with non-severe compressive nerve root signs, all of which are typical exclusion 
criteria in studies of acute LBP.  
2.3.9 Rationale for patient-reported outcomes: This study will also measure 
patient-reported outcomes with the Oswestry questionnaire. Since 1994, there 
has been a growing recognition in the treatment of back pain that patient 
perspectives are essential in judging the results of treatment. In fact, many 
experts argue that improving the patient's "quality of life" is often the main goal 
of therapy. Consequently, research in LBP has shifted dramatically from 
physiologic outcomes (e.g., range of motion, muscle strength, neurologic 
deficits) to rigorous measurement of patient-reported outcomes such as pain, 
functional status, medication use, role function, quality of life, satisfaction with 
treatment, and work status. In many cases, functional outcomes can be 
measured with a high level of reproducibility. Because symptoms and 
functional outcomes are sometimes only loosely associated with physiologic 
phenomena in LBP research, the functional outcomes should be measured 
directly. Modern questionnaires for measuring patient quality of life combine the 
expertise of social scientists, clinicians, and patients to result in excellent 
reliability and validity.  
Through qualitative interviews with patients with LBP who were familiar with 
PT, several accepted LBP-specific instruments designed to measure health-
related quality of life were reviewed. Patients were asked for candid judgments 
of whether the items on the outcome instruments adequately represented what 
was important to them. Surprisingly, some items were uniformly rejected by the 
patients, such as numeric pain ratings and global ratings of change, both of 
which are considered essential and widely accepted in the LBP literature. 
Instead, questionnaires that dealt with functional ability (e.g., Oswestry) were 
uniformly endorsed, with patients confirming the relevance of the items to their 

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problem and even going as far to say the instrument helped them to articulate 
how their problem was affecting their everyday life. Consequently, patients also 
stated that any study that demonstrated improvement in the items listed on 
outcome assessment forms, such as the Oswestry, would be relevant to them.  
2.3.10 Non-reliance on clinician expertise: Other than providing updates to existing 
guidelines through standard continuing education courses, this study does not 
require additional expertise on the part of PCPs or physical therapists in either 
arm. In both study arms, high risk patients will be identified in the EMR at the 
PCP office. In the GBC arm, the high risk patients will be identified for the 
PCPs, and the PCP will be given the freedom to treat the patient according to 
their individual clinical judgment. Matched interventions (advice to stay active, 
cognitive behavioral approaches, education, etc.) will be recommended through 
the EMR. In the intervention GBC+PIPT arm of the study, high risk patients will 
be identified and PIPT will be recommended. To keep the trial pragmatic, the 
treatments will be made available with an explanation of potential benefits to 
patients in their respective study arms as well as referrals when applicable. 
There will be no undue pressure to comply with the treatments in either arm of 
the study. This is consistent with the PRECIS-2 domain of flexibility (delivery). 
PIPT training will be provided to physical therapists to whom patients are 
commonly referred by the PCP offices. The continuing education courses for 
physical therapists will be limited to 8 hours, far less than the licensure 
requirements in the states participating, and physical therapists will not be 
restricted due to expertise. Continuing education will be focused on reviewing 
the principles of PIPT and not dictating to physical therapists exactly how the 
interventions are to be carried out.  
2.3.11 Potential risks: Due to the highly pragmatic nature of this study, the risks of 
either of these interventions are minimal. All aspects of patient care are within 
normal clinical practice and under the control of clinic-based practitioners. Any 
risks would be subject to the PCP or PT sites’ normal patient safety 
procedures. 
 
 

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3 Study design 
3.1 Primary, secondary and additional study designs 
 
 
Figure 1. Diagram of sample size by cohort and study arm 
3.1.1 Primary study (PA1-2, SA3, SA5): The primary study is a multi-site cluster 
RCT comparing GBC with GBC+PIPT for patients with acute LBP deemed to 
be high risk for transition to chronic LBP (RCT cohort). Data collection will be 
conducted at baseline, 6 months, and 12 months. Resource use, determined 
with EMR data, will be evaluated in a subset of patients. 
3.1.2 Secondary study (SA4-5): A secondary ancillary prospective, observational 
cohort study will be conducted for those patients presenting with acute LBP 
Assessed for Eligibility 
 
Baseline Measures 
Chronic LBP Questionnaire 
STarT Back Tool 
Oswestry  
Observational Cohort 
Acute LBP: Low/Medium Risk 
 
RCT Cohort 
Acute LBP: High Risk 
 
Excluded: Chronic LBP 
 
GBC + PIPT 
 
GBC 
 
6-Month Assessment 
Chronic LBP Questionnaire 
Oswestry 
12-Month Assessment 
Resource Utilization 
 
6-Month Assessment 
Chronic LBP Questionnaire 
Oswestry 
12-Month Assessment 
Resource Utilization 
 
PIPT Checklist 

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deemed to be low or medium risk. Patients with acute LBP who do not meet 
criteria for high risk will be identified for the prospective observational cohort. 
These patients will receive GBC and not be targeted with any specific study 
interventions, such as PIPT.  Data collection will also occur at baseline, 6 
months, and 12 months. The objective of this ancillary observational study is to 
precisely determine the rates of transition from acute to chronic LBP and 
resource use in the treatment of LBP. 
3.2 Randomization 
The study will be conducted in five distinct US geographical areas in each of which a 
minimum of 12 primary care clinics will be participating and enrolling patients. The unit 
of cluster randomization will be the primary care clinic site. Thus, in one geographical 
area, six PCP clinics will be randomized to the GBC arm and six to the GBC+PIPT 
arm. The unit of randomization and analysis is a cluster because the intention is to 
enhance the application of a stratified approach to treating LBP in primary care 
environments as a whole while minimizing contamination.67 When randomization at the 
individual level was considered, it was found to be impractical and susceptible to 
selection bias and contamination.  
The randomization for each study site will be conducted by the study biostatistician 
and will be stratified by two factors: Total Back Pain Encounters (Factor 1) and % 
Medicaid/Self-Pay (Factor 2). First, the clinics will be ordered by Factor 1 and divided 
into subgroups (blocks). Clinics in each block will then be further ordered by Factor 2, 
and randomly assigned to either group A or group B, making sure that the two groups 
would be balanced in terms of both Factor 1 and Factor 2. 
3.3 Primary, secondary, and additional study outcomes 
3.3.1 The first primary outcome of the study (PA1) is the presence or absence 
of chronic LBP. This is determined through the patients’ answers to a two-
item Chronic LBP Questionnaire based on criteria developed by the NIH Task 
Force on research standards for chronic LBP.42 The questions are: 1) How long 
has low back pain interfered with your ability to do regular daily activities? 2) 
Think only about the past 6 months.  How often has low back pain interfered 
with your ability to do regular daily activities?  Chronic LBP is defined as a 
response of “more than three months” to question 1, and a response of “half 
the days or more than half the days” in the past 6 months to question 2.  
3.3.2 The second primary outcome of the study (PA2) is the Oswestry 
Disability Index.68 Originally described by Fairbanks et al,68 the Oswestry LBP 
Questionnaire is a reliable, well-validated, easily-administered, disease-specific 
measure that results in an index of a patient’s perceived level of function due to 
LBP and is based on ten areas of performance. Items include how the back 
pain impacts the patient’s ability to care for themselves (washing, dressing, 
etc.), lift, walk, sit, stand, and sleep. It also assesses the effect of the pain on 
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stakeholders unanimously find this type of instrument more patient-centered 
than the standard pain numerical rating scale and believe that the Oswestry 
represents functional activities that can become impaired when they 
experience back issues and are important to them to overcome. Each area is 
scored from 0 - 5 with zero representing no limitation and five representing 
maximal limitation. The ten areas, which include an assessment of pain 
intensity, are added together, resulting in a maximum score of 50. This score is 
doubled and interpreted as a percentage of patient-perceived disability, with 
higher scores representing greater disability. 
3.3.3 A secondary outcome (SA3-5) is LBP-related medical resource utilization, 
including 1) referrals to specialists (e.g., orthopedists, spine surgeons, 
physiatrists) and other health care providers, 2) tests (e.g., MRIs), surgical 
procedures (e.g., epidural steroid injections, laminectomy), and 3) prescription 
analgesics including opioids.  
3.4 Study population and sites 
The target population for this study will be adult patients who present to primary care 
physicians (i.e., internal medicine, family practice, and geriatric medicine physicians) 
with a primary complaint of LBP. Patients will be recruited from health systems in five 
regional areas that surround: 1) Pittsburgh, PA (UPMC); 2) Boston, MA (Boston 
Medical Center); 3) Baltimore, MD (Johns Hopkins Medicine); 4) Charleston, SC 
(Medical University of South Carolina); and 5) Salt Lake City, UT (Intermountain 
Healthcare). Within the individual regional areas, primary care clinics have been 
identified that represent community-based PCP clinics. In all instances, there are more 
potential sites than are required for successful completion of the trial, which will allow 
flexibility in the randomization scheme and alternatives should there be individual 
PCP-clinic recruitment shortfalls. This large, nation-wide group of clinics across five 
different health systems provides a high level of pragmatism for the PRECIS-2 
organizational domain because the systems will be variable with regards to provider 
expertise, resources, and organizational structure. 
Certain patient subgroups are of particular interest (SA5) given greater risk for poorer 
LBP outcomes as demonstrated in observational cohort studies. Adequate enrollment 
will be assured to have statistical power to conduct subgroup analyses of patients with 
lower socioeconomic status (using insurance as a proxy) and the comorbid conditions 
of smoking, depression, and obesity.11,69-71 Identification of subgroups will be based on 
information obtainable in the EMR. The participating primary care clinics will be 
sampled to reflect gender, race, and ethnicity proportions of the population being 
served at the recruitment sites.  
 
 

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4 Selection and enrollment of participants 
4.1 Inclusion criteria  
Inclusion criteria for the study are:  
1) 18 years of age or older, and 
2) Receiving care for acute low back pain (i.e., does not meet the criteria for 
chronic LBP) during a primary care clinic visit. 
An even distribution of age from 20-60 years of age is expected with a slight drop off 
after age 60, due to LBP becoming more of a chronic problem with aging. The lower 
age limit on recruitment of 18 years was included based on stakeholder feedback from 
internal medicine and family medicine colleagues that pointed out the different nature 
of LBP in adolescents. Gender is expected to be 50% male and race/ethnicity will 
closely match those in the geographical location of the sites. English language 
proficiency will not be an inclusion criterion because it is assumed that clinics with a 
significant non-English population will have translation capabilities for that population. 
4.2 Exclusion criteria  
Exclusion criteria are limited to medical contraindications to physical therapy based on 
the judgement of the PCP as documented in the EMR (i.e., “red flag” signs and 
symptoms of a potentially serious condition such as cauda equina syndrome, major or 
rapidly progressing neurological deficit, cancer, spinal infection or fracture).72 
4.3 Study enrollment procedures  
4.3.1 Subjects will be enrolled at all of the PCP clinics selected for the trial. In 
keeping with the pragmatic nature of the trial, all patients will be admitted into 
the trial who present with a complaint of acute back pain. Recruitment 
(PRECIS-2 domain) is highly pragmatic being solely based on patients 
presenting to the clinic with back pain. 
4.3.2 Randomization: The study is a cluster RCT; randomization of treatment arm 
assignment is at the clinic level, not the individual patient. Enrollment will be the 
same for both arms of the study.  
4.3.3 Screening procedures: Using patient portals, clinic-based tablets, or manual 
questionnaires, administrative staff or clinicians at the PCP sites will administer 
a baseline assessment with three components that will be included in the 
patients’ EMR. At all sites, the EMR will be modified to accept these data 
elements: 
1) The 2-item Chronic LBP Questionnaire (Appendix 1),42 
2) The 9-item STarT Back Tool to stratify risk for transition to chronic LBP 
and identify high risk patients (Appendix 2),41 
3) The 10-item Oswestry LBP Questionnaire (Appendix 3). 

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4.3.4 Ineligibility and non-participation: Patients with chronic LBP will be 
documented as not eligible and will not be enrolled for intervention or 
subsequent assessments. Patients refusing to complete the baseline 
assessments will be documented as refusing screening and not included in the 
enrollment for intervention or subsequent assessments.  
 

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5 Study interventions  
Table 1: Study intervention components by study arms 
Intervention components 
GBC 
GBC+PIPT 
Training of non-clinical and clinical staff at PCP offices 
on patient identification and data collection (QI) 
 
 
PCP primer of LBP guidelines (QI) 
 
 
PCP and clinical staff instruction on stratification and 
referral to PIPT (QI) 
 
 
Training for physical therapists on PIPT (QI) 
 
 
Identification of LBP patients upon scheduling 
appointments or arrival in clinic (QI) 
 
 
LBP patient completion of questionnaires (Chronic LBP, 
STarT Back, Oswestry) (QI) 
 
 
Patient questionnaire results given to PCPs in EMR (QI) 
 
 
Acute LBP patient informed consent and enrollment in 
study for assessments at 6 months and review of 
medical record data (Research) 
 
 
Acute LBP high risk patients referred to PIPT (QI) 
 
 
Acute LBP high risk patients attend PIPT session (QI) 
 
 
PT performs PIPT for acute LBP high risk patients (QI) 
 
 
PT completes checklist and returns to PCP for acute 
LBP high risk patients (QI) 
 
 
6-month assessment for all acute LBP patients 
(Research) 
 
 
12-month EMR resource use assessment for all acute 
LBP patients*(Research) 
 
 
*EMR data for UPMC, BMC, JHM, IH 
 
 
 
5.1 Interventions, administration, and duration 
5.1.1 Referral to PIPT: As a result of the QI initiative, all patients in the intervention 
arm identified as high risk will be referred to PIPT. PCPs will have the results of 
the screening questionnaires in the EMR to identify the high risk acute LBP 
patients and refer them to PIPT. PCPs will provide patient education materials 
as appropriate, including materials about musculoskeletal injury, PT, and pain 
management. Referrals will occur through automatic electronic referral, manual 
electronic referral, written prescription, fax, or verbal means. 
5.1.2 Delivery of PIPT: Upon referral to PIPT, trained physical therapists will use the 
PIPT approach with the high risk patients. The number of PT sessions 
recommended by the physical therapist will be based on their clinical judgment. 
Physical therapists will complete a checklist based on PT standards of care 
(see Appendix 4 based on Guide to Physical Therapy Practice 
http://guidetoptpractice.apta.org/) that will reflect the elements of the treatment 
provided. This checklist will be sent to the PCP and entered into the EMR. This 

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checklist will allow tracking of how many patients have received the prescribed 
physical therapy (i.e., a completed checklist, number of PT sessions). 
5.1.3 Patient-centered PIPT discharge instructions: Community discussions with 
patients emphasized the desire to have a home exercise program in place after 
physical therapy that is feasible, effective, and sustainable. As an adjunct to the 
PIPT program, physical therapists can provide patients at discharge printed 
instructions for home practice exercises and a list of recommended community-
based exercise classes and resources appropriate for the patient. 
5.1.4 Patient-reported outcomes: At 6 months for all sites, lists of eligible patients 
will be generated from the EMR and patients will be contacted by research 
assistants by phone, email, or postal mail. This procedure is a modest 
departure from the pragmatic approach (PRECIS-2 follow-up domain); 
however, stakeholders indicated that 6-month assessments of this nature were 
not normal practice for the PCP clinics. These assessments will be for the 
Chronic LBP Questionnaire and Oswestry. 
5.2 Handling of study interventions  
5.2.1 PCP clinic instruction: As part of the QI initiative, all PCP clinic sites will 
receive instruction on how to identify and collect patient-reported outcomes for 
patients with back pain. QI staff will work with physician champions at each 
practice site and their staff to ensure smooth processes for administering the 
screening tools. They will also receive an educational presentation, including a 
primer on guidelines for LBP, an overview of the Chronic LBP Questionnaire, 
the STarT Back Tool, and the Oswestry. Sites included in the GBC arm will not 
be instructed to alter their normal clinical procedures beyond data collection 
while those in the intervention arm will be coached by QI staff on referral to 
PIPT. 
5.2.2 PIPT physical therapist education: To educate physical therapists in the 
referral areas for the intervention arm, a PT continuing education program will 
be provided for physical therapists that includes PT guidelines, principles of 
PIPT, clinical application, and adherence. Initial training of physical therapists 
will consist of a 1-day (8-hour) course that offers:  
1) A condensed and focused summary of the principles of pain 
neuroscience and cognitive behavioral therapy (CBT), 
2) Case examples of using PIPT principles with back pain patients, 
3) Basic training in specific communication skills and styles that can 
enhance patient motivation for attitudinal and behavioral change, and 
4) Interactive, experiential training in delivering brief educational and 
PIPT approaches.  
Ongoing training to promote adherence to the PIPT skills in clinical treatment 
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discussion groups, and an adherence checklist for use during treatment of high 
risk patients. The intervention is designed to be a practical, patient-centered, 
and activity-based treatment, and will utilize American Physical Therapy 
Association (APTA) Orthopaedic Section Clinical Practice Guidelines.56  
5.3 Concomitant interventions  
In keeping with the pragmatic nature of the trial, there will be no restrictions on patients 
taking part in other clinical trials. 
5.4 Adherence assessment  
5.4.1 Patient adherence: Patients will be compensated for their participation in data 
collection: one payment of $15 will be mailed after the completion of the 6-
month assessment. All care will be paid for through existing health insurance 
benefit structures, established programs for underserved patients, or will be 
self-pay.  
5.4.2 Provider adherence: Approaches will be implemented to enhance provider 
adherence within the context of the EMR. PCP stakeholders strongly believed 
that time restrictions would not permit them to enter into the EMR the data 
necessary to identify baseline characteristics (2-item chronic questionnaire, 
STarT Back Tool, and Oswestry LBP Questionnaire). As a result, the portal or 
tablet-based approaches programmed within the EMR environment would be 
the first line of data collection utilized uniformly throughout the study sites. 
Portal and tablet-based approaches are becoming increasingly implemented in 
PCP environments, supporting generalizability. The study team will not dictate 
treatment fidelity approaches for PT provider adherence, but will implement a 
“checklist” that includes reference guidelines for the PIPT approach. This 
checklist will be included in the routine communication that occurs between the 
physical therapist and a referring PCP. 
 
 

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6 Study procedures  
6.1 Schedule of evaluations 
Table 2: Schedule of evaluations 
Assessment 
Screening and 
Enrollment 
6-Months 12-Months 
Chronic LBP Questionnaire   
 
 
 
STarT Back Tool 
 
 
 
Oswestry LBP Disability Index 
 
 
 
EMR Medical Resource Use* 
 
 
 
*EMR data for UPMC, BMC, JHM, IH 
A detailed flow diagram for each regional site is provided in Appendix 5. 
6.2 Description of evaluations  
6.2.1 Screening evaluation: Patients receiving care for acute back pain will be 
given the three-part assessment during the PCP visit scheduling process (up to 
seven days prior) or upon arrival at the clinical site. Candidates will be deemed 
eligible for the study if they are identified as an acute LBP patient. Those in the 
high risk STarT Back group will be identified for enrollment in the RCT for the 
primary and secondary outcomes, and those in the low or medium risk STarT 
Back groups will be identified for enrollment in the observational cohort for 
secondary outcomes. The screening evaluations are part of normal practice, 
and results for all screened patients will be available for clinical staff to use in 
the EMR. 
6.2.2 Consent process: The University of Pittsburgh Institutional Review Board 
(IRB) has approved a waiver of informed consent/HIPAA authorization to 
access, record, and use protected patient health information/patient medical 
record information for review and analysis of medical recorddata for the 
conduct of this study at UPMC clinics and Intermountain Healthcare clinics. It 
has also approved a waiver for the requirement to obtain a written informed 
consent for completion of questionnaires and interviews at those sites. Verbal 
consent will be obtained by telephone  or electronic consent by email prior to 
the 6-month assessment by research staff from the University of Pittsburgh. A 
letter will be mailed from the Healthsystem prior to the contact by research 
personnel to inform the patients about the research study and provide them an 
option of opting out of receiving any additional follow up by calling a project 
office telephone number or sending an email message to the project email 
address.  Participants will be given the option of completing the 6-month 
assessment as a hard copy self-report, which will be mailed to the project office 
with a consent template with their name recorded for tracking. The research 
involves no more than minimal risk to the participant, the waivers will not 

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adversely affect the rights and welfare of the participant, and the research 
could not practicably be carried out without the waivers.  
 
Specifically, 
• 
The study is comparing two standard-of-care treatments that patients could 
receive regardless of participation in the study, 
• 
These standard clinical approaches do not require consent outside of the 
research context, 
• 
A total sample size of at least 8,760 participants is needed from these sites 
to meet the aims of the study,  
• 
The study needs to be conducted within the clinical setting (i.e., a 
pragmatic trial), which typically allows <15 minutes per patient visit; the 
consent/authorization procedures would disrupt the clinical setting and 
potentially impact patient care. 
6.2.3 Enrollment and baseline evaluation: Upon determination of eligibility, 
patients will be enrolled in the QI initiative of the study. Baseline data will be 
contained in the EMR and extracted for study purposes, including screening 
results, demographic information, billing information, and clinical data (e.g., 
diagnoses, referrals to specialists). Patients identified as high risk, acute LBP 
patients in the intervention arm will be referred to PIPT, and this referral will 
also be captured in the EMR. The list of baseline variables to be extracted from 
the EMR is provided in Appendix 6. 
6.2.4 Randomization: As a cluster RCT, randomization will occur at the clinic level 
and not the patient level; therefore, randomization is not a factor in the 
enrollment or baseline evaluation. 
6.2.5 Follow-up: Follow-up to the initial screening and QI enrollment visit will occur 
through three mechanisms: 
1) Referral to PIPT: For eligible patients referred to PIPT, follow up at PT 
will be evaluated through the checklist completed at the PT visit and 
returned to the PCP site. This checklist will indicate use of the PIPT 
approach and number of PT sessions. 
2) Six-month assessment: Research staff will contact all enrolled 
patients 6 months after their initial visit at all sites and conduct the 
Chronic LBP Questionnaire and the Oswestry to assess the primary 
outcomes.  
3) Medical resource utilization: Researchers will also extract data from 
the EMR at select sites  to determine the secondary outcome of LBP-
related medical resource utilization of tests, procedures, and 
pharmaceuticals by enrolled patients for 12 months after the initial visit. 

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The list of variables for medical resource utilization is provided in 
Appendix 6. 
7 Safety assessments  
All clinical activities related to this trial will be performed in accordance with normal clinical 
practice. Safety concerns and adverse events arising from clinical operations within the 
PCP or PT settings will also follow normal clinical procedures. Adverse events related to 
the research study would be limited to a data breach of confidentiality. This would not 
require patient report but would require study report, following Office of Information Security 
protocols at the University of Pittsburgh for reporting and resolution.  
8 Intervention discontinuation 
Enrollees who do not follow the clinical practices contemplated within this trial or do not 
respond to the follow-up calls will be documented but not discontinued. 
9 Statistical considerations 
9.1 General design issues  
9.1.1 A primary aim (PA1) is to determine in patients with acute LBP who are 
deemed high risk for transition to chronic, what is the proportion of patients 
transitioning to chronic LBP by the time of the 6-month assessment who are 
treated with 1) GBC compared to 2) GBC+PIPT. 
9.1.2 H1: GBC+PIPT will be more effective than GBC alone for preventing patients 
with high risk acute LBP from transitioning to chronic LBP. 
9.1.3 The primary outcome will be determined by patients’ responses to the Chronic 
LBP Questionnaire at 6 months. The proportion of patients that have 
transitioned will be compared across the two study arms. 
9.1.4 PA2 is to compare patient-centered outcomes of LBP-related function (e.g., 
lifting, walking, sleeping) for high risk patients between the two study arms at 
the 6-month assessment. 
9.1.5 H2: GBC+PIPT will be more effective than GBC alone for improving functional 
outcomes for patients with high risk acute LBP. 
9.1.6 This primary outcome will be measured using patients’ responses to the 
Oswestry LBP Questionnaire at baseline versus at 6 months to determine 
changes in the score.  
9.1.7 SA3 is to compare acute LBP-related medical resource utilization (e.g., 
imaging, epidural steroid injections, opioids) for high risk patients between the 
two study arms. 

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9.1.8 H3: GBC+PIPT will be more effective than GBC alone for reducing LBP-related 
medical resource utilization for patients with high risk acute LBP. 
9.1.9 This secondary outcome will be measured by retrieving patient medical 
resource utilization data from the EMR for LBP-related tests, procedures, 
specialty visits, and pharmaceuticals for 12 months after the initial visit. 
9.1.10 SA4 is related to PA1-2 and SA3 but will determine the proportion of medium 
and low risk patients that transitions to chronic LBP; patient-centered outcomes 
(e.g., functional impact); and LBP-related medical resource utilization. 
9.1.11 Outcomes for this aim will utilize the same measures and sources as PA1-2 
and SA3 for the medium and low risk patients. 
9.1.12 SA5 is to conduct subgroup analyses for PA1-2 and SA3 on patients with lower 
socioeconomic status (using insurance as a proxy) and the co-morbid 
conditions of smoking, depression, and obesity. 
9.1.13 H5: GBC+PIPT will have less transition to chronic LBP and will be more 
effective than GBC alone for improving functional outcomes and reducing LBP-
related medical resource utilization for the subgroup of patients who are 
underserved or with depression. Because the interventions being studied do 
not specifically target obesity and smoking, and the relationship of these 
variables to transition to chronic are unclear, group x obesity interactions are 
not expected. 
9.1.14 Outcomes for this aim will utilize the same measures and sources as PA1-2, 
SA3 but will also include EMR data on patient co-morbidities, smoking status, 
and socioeconomic status. 
9.1.15 Missing data: Baseline characteristics, such as age, gender, and health 
insurance status, will be compared between patients with complete 
assessment data to those with missing data by treatment group in order to 
assess potential biases that may exist in the complete case analysis. 
Sensitivity analyses for the primary and secondary outcomes will be conducted 
using several methods, which have different missing data assumptions.73  
1) Complete case analyses, which assumes missing data are completely at 
random, 
2) Multiple imputation using M=10 imputations, which assumes missing at 
random, and 
3) Assigning poor scores and good scores for missing values differentially 
by treatment group, which aligns with non-ignorable missingness (the 
data missingness is nonrandom and related to the actual value).   
  

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9.2 Randomization, sample size and power – RCT cohort 
9.2.1 Randomization will occur at the clinic level, which was chosen for the 
pragmatic reason that randomizing patients within a clinic would result in cross 
contamination of the interventions within the same clinic. The biostatisticians 
and the individuals conducting the 6-month assessments will be blinded to the 
randomization assignment to avoid bias in analyses and data capture.  
9.2.2 Sample size is based on the first primary outcome of the transition rate to 
chronic LBP at month 6. We propose to enroll N=1860 high risk acute LBP 
patients. We are targeting an average of n=31 enrolled high risk patients per 
clinic (60*31=1860) to account for the variation in cluster sizes (assuming 
coefficient of variation=0.65) and 40% non-response rate at 6 months.  
9.2.3 Power: With a total of 60 PCP clinics for randomization, m=30 clinics per 
intervention strategy and fixed n=10-14 completers per clinic for the 6-month 
assessment, we will have just over 80% power to detect a 40% reduction in 
transition to chronic LBP assuming the control arm has a transition rate of 25%-
30% and the intraclass correlation is 0.05, which is an upper bound for what 
has been observed in other cluster randomized trials with respect to either pain 
of LBP. Assuming that low and medium risk subjects with acute LBP have an 
expected 20% transition to chronic and using data on obesity and smoking 
rates based on national surveys, depression rates based on prevalence rates 
reported in primary care, and proportions of underserved patients estimated 
from patient registries at each of the five regional sites, the planned sample 
size for the observational cohort is sufficient to detect at least a 30% relative 
difference (6% absolute difference) from 20% with powers ranging from 79% to 
87%. The study would have 65% power to detect a 40% relative or 8% 
absolute difference (hypothesized increased rate of transition) for the 
depression subgroup.    
9.2.4 Treatment assignment procedures: Detecting an interaction effect the same 
size as the overall intervention effect would require a four-fold increase in the 
effective sample size (more clinics and patients accounting for clustering), 
which is not feasible.82 There will be sufficient power to detect stronger 
intervention effects in some a priori defined subgroups at the participant level 
(smoking, depression, obesity, lower SES) if the cohort is evenly split.  
9.2.5 Analysis of randomization: Distributions of baseline characteristics for clinics 
and patients will be compared between the study arms to assess effectiveness 
of the randomization, and statistical or clinical differences will be adjusted for in 
sensitivity analyses. All analyses for treatment group comparisons will use an 
intention-to-treat approach and results will be reported using the CONSORT 
extension to cluster randomized trials.83 This approach is highly pragmatic per 
the PRECIS-2 primary analysis domain. 

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9.3 Randomization, sample size and power – observational cohort 
9.3.1 Randomization is not applicable to the observational cohort because 
moderate and low risk patients will not receive the PIPT intervention. 
9.3.2 Sample size is again based on a total of 60 PCP clinics. An average of n=115 
patients will be enrolled per clinic, for a total sample of N=6,900 low or medium 
risk acute LBP patients.  
9.3.3 Power: The sample size will allow precise determination of 1) the transition 
rates for low risk and medium risk acute LBP who receive GBC; 2) differences 
between low/medium risk patients receiving GBC in the observational cohort 
and high risk patients receiving GBC in the intervention group; and most 
importantly, 3) differences among low/medium risk patients due to specific 
subgroup characteristics, in particular patients who are underserved, obese, 
depressed, or smokers. Of the three objectives, the subgroup analyses require 
the greatest sample size, and therefore will be described in detail here. 
For the purposes of the calculations, from the literature it is assumed that low 
and medium risk subjects with acute LBP have an expected 20% transition to 
chronic. Data on obesity and smoking rates are based on national surveys. 
Depression rates are based on prevalence rates reported in primary care. 
Proportions of underserved patients are estimated from patient registries at 
each of the five regional sites. For the underserved, obesity, and smoking 
subgroups, the given sample sizes in Table 3 would be ample enough to detect 
at least a 30% relative difference (6% absolute difference) from 20% with 
powers ranging from 79% to 87%. The study would have 65% power to detect 
a 40% relative or 8% absolute difference (hypothesized increased rate of 
transition) for the depression subgroup.   
Table 3: Power at a significance level of 0.05 to detect the specified % absolute and 
relative differences from a 20% chronic transition rate based on a two-sided Z-test 
adjusted for clustering within clinic (ICC=0.01) among 60 clinics, N=6900 enrolled and 
conservatively 60% response rate at 6 months in the low or medium risk population 
(adjusting for design effect and nonresponse N=2464). 
Subgroups (N) 
25% 
relative 
difference 
(5% 
absolute 
difference) 
30% 
relative 
difference 
(6% 
absolute 
difference) 
35% 
relative 
difference 
(7% 
absolute 
difference) 
40% 
relative 
difference 
(8% 
absolute 
difference) 
Underserved (n=665 of 
2464) 
74 
87 
95 
98 
Obesity (n=640 of 2464) 
73 
86 
94 
98 
Depression (n=184 of 2464) 
33 
44 
54 
65 
Smoking (n=493 of 2464) 
64 
79 
89 
95 

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9.4 Outcomes  
9.4.1 Primary outcome 1: To test the effect of the intervention on preventing the 
transition from acute to chronic LBP (PA1), the study team will compare the 
rates of transition to chronic LBP at 6 months, based on the results of the 6 
month Chronic LBP Questionnaire, between enrolled patients at intervention 
clinics and enrolled patients at comparator clinics. This comparison will be 
conducted for high risk patients at 6 months (PA1) as well as  low and medium 
risk patients (SA4) and specific subgroups (SA5). 
9.4.2 Primary outcome 2: To test the effect of the intervention on improving patient-
centered outcomes of back-related function (PA2), the study team will compare 
changes in the Oswestry scores from baseline to 6-month assessment 
between enrolled patients at intervention clinics and enrolled patients at 
comparator clinics. This comparison will be conducted for high risk patients at 6 
months (PA2) as well as low and medium risk patients (SA4) and specific 
subgroups (SA5). 
9.4.3 Secondary outcomes: To test the effects of the intervention on reducing 
medical resource utilization (SA3) the study team will compare LBP-related 
medical resource utilization data for enrolled patients at intervention clinics and 
enrolled patients at comparator clinics for a period of 12 months. This 
comparison will be conducted for high risk patients (SA3) as well as low and 
medium risk patients (SA4) and specific subgroups (SA5). The medical 
resource utilization data will be identified and categorized using Healthcare 
Common Procedure Coding System (HCPCS) Level 1 (CPT-4) and 2, and ICD-
10 codes.  These data will be used to evaluate the frequency, intensity and 
composition of services received within the participating PCP/PT practices as 
well as care delivered in other community practices and facilities.  The study 
team will investigate evaluation & management services (PCP & specialist), 
diagnostic testing, rehabilitation services, and medical procedures.  
Furthermore, the study team will also capture prescribing patterns for key drug 
classes commonly used for LBP management such as non-steroidal anti-
inflammatory drugs (NSAIDs), acetaminophen (Tylenol), opioid analgesics, 
skeletal muscle relaxants, antidepressants (e.g., tricyclic antidepressants and 
duloxetine), and drugs for neuropathic pain (e.g., gabapentin).38 
9.5 Data analyses  
9.5.1 Primary outcome 1: This initial analysis (PA1) will use a generalized linear 
mixed model with a logit link controlling for block set (see Randomization) and 
a fixed effect for intervention accounting for the cluster RCT design with a 
random clinic effect. Primary analyses will also adjust for patient characteristics 
(maladaptive pain coping behaviors such as catastrophizing and fear 
avoidance, functional impairment as measured by the Oswestry, and presence 

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of psychiatric comorbidities), as these have been associated with higher 
transition to chronic LBP.69 The intraclass correlation coefficients will also be 
estimated and reported for all outcome measures to assess the assumptions 
for sample size analyses and also for future investigations using similar 
designs and outcomes. Analysis for the secondary aims (SA4 and SA5) will be 
largely descriptive assessing the proportion of patients who transition to chronic 
LBP among the low and moderate risk observational cohort. The proportion 
and confidence interval will be estimated using generalized linear models 
adjusting for clustering.  
9.5.2 Primary outcome 2: This aim (PA1) will be analyzed using contrasts from a 
linear mixed models analysis for 6-month back-related function (Oswestry) 
controlling for baseline Oswestry and the block set (see Randomization). The 
intervention will first be explored by time interaction, and then proceed to a 
main effects model with only group and time.  For the secondary aims (SA4 
and SA5) patient-centered outcomes, such as functional status, would use 
general linear models if deemed appropriate based on normality assumptions. 
If normality is hugely violated, a cutpoint for ‘response’ will be applied. 
9.5.3 Secondary outcome: Analyses of health care utilization data (SA3) will use 
generalized linear mixed models with the distribution determined by the type of 
data but still controlling for the cluster randomized trial design by having 
random effects for clinics. Logit link (binary distribution) will be used for health 
care outcomes, such as surgery, that are dichotomous (Yes/No) variables. For 
outcomes resulting in count data over the time frame such as number of 
outpatient visits for back pain, hospitalizations or ER visits, Poisson or negative 
binomial distribution with log link will be used to compare the event rates 
controlling for the period of follow up. The secondary aims (SA4 and SA5) 
would use a similar approach. 
 
 

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10 Data collection and quality assurance 
10.1 Data collection 
10.1.1 Baseline data: Data collection for the three baseline patient questionnaires 
(Chronic LBP Questionnaire, STarT Back, and Oswestry) will be self-report via 
an internet-based form in a patient portal, a tablet-based form, or a paper 
questionnaire. The forms via patient portal or tablet will be loaded into the 
EMR. For paper questionnaires, the medical assistant will enter the data 
directly into the EMR. The PT checklist will be completed either electronically or 
on paper, and will also be loaded into the EMR. 
10.1.2 Follow-up data: The study team will extract data from the EMR to determine 6-
month assessment dates for enrolled patients. These data will be collected by 
the study team via telephone or e-mail, or as participant hard copy self-report 
returned to the project office, entered into a database, and matched with the 
EMR data.   
10.1.3 Medical resource utilization data: Data for LBP-related use of medical 
resources during the 12-month assessment period will be collected for four of 
the five regional sites (Pittsburgh, Boston, Baltimore, and Salt Lake City). All 
four regional study sites participate in robust clinical research data networks 
(CRDNs).  Boston Medical Center has access to the Clinical Data Warehouse 
of Boston University Medical Campus and Boston HealthNet, a partnership 
between Boston Medical Center, Boston University School of Medicine, and 15 
community health centers that are participating in the study. Data from these 
resources will allow the capture of comprehensive information regarding the 
LBP-related medical resource utilization (e.g., office visits, specialty visits, 
tests, procedures, prescriptions, surgeries).   
10.1.4 Data sweeps: The EMR administrators and programmers at each site have 
agreed to work with the study team to provide all necessary data. Reporting 
needed for the aims are related to data that need to be regularly pulled from 
the EMR and provided to practice managers and study personnel. These 
include: 
1) Total numbers of subjects with LBP ICD-10 codes or who received care 
for back pain during the primary care clinic visit, 
2) Total numbers of subjects with completed data elements that include: 
• 
Chronic LBP Questionnaire 
• 
STarT Back Questionnaire 
• 
Oswestry LBP Questionnaire 
All sites have agreed to program into the EMR the data elements above. They 
also agreed to program: 
1) Bi-weekly sweeps of the EMR with a report that documents the ratio of 
completed data sets to total patients enrolled with LBP by clinic. These 

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will be used to assure appropriate recruitment levels at all sites. Reports 
will be directed to PCP champions and staff responsible for the clinic.   
2) Regular reports from all of the EMRs of the data elements as well as the 
common data elements. These will be de-identified and sent to the 
coordinating site (Pittsburgh), where the Data Integrity Committee will 
work to harmonize all of the data integral to the primary aims of the study 
from the 5 sites. 
10.2 Data management  
10.2.1 Data coordination and quality monitoring: The University of Pittsburgh will 
manage data from the 5 regional sites’ EMR teams. Monitoring of the trial will 
be facilitated through regular reports provided to the PIs and the Steering 
Committee. University of Pittsburgh staff have experience regularly running 
reports for other trials to monitor recruitment, enrollment, protocol 
implementation, attrition, and safety.  They are also experienced with 
generating Data and Safety Monitoring Reports in both open and closed 
formats. 
10.2.2 Data source adequacy: In choosing sites, major criteria were an established 
EMR linked with networked PCP clinics. All of the sites fit this criterion. One of 
the criteria for eligible PCP clinics was past volume of patients with LBP, 
identified by the ICD-9 code list. All sites conducted a data sweep representing 
calendar year 2013. In order to be an acceptable clinic site for the study, clinics 
needed to have a minimum of 400 patients with LBP diagnoses. Most of the 
selected clinics were far above that number. The conservative estimate is that 
that 10% of the 400 (40 per clinic) would be acute and high risk and therefore 
eligible, based on past literature for chronic rates, which range from 8-10%.4,88 
In addition, a payer stakeholder, OPTUM, shared data with us based on first-
time visits at primary care clinics across the country. Their analysis of chronicity 
(defined as 2 or more subsequent visits six months after the initial visit) verified 
a chronicity rate of <20%. Given the literature on chronic LBP and the STarT 
Back Tool, and data from OPTUM, 10% is a conservative estimate for a yearly 
yield of 31 patients per clinic.   
10.3 Quality assurance 
10.3.1 Methods used to ensure unbiased and systematic data collection from all 
participants: The major sources of potential bias in data collection with a 
cluster-RCT design lie in 1) the selection of sites and 2) missing or incomplete 
data collection once subjects are enrolled within a site. EMRs of all 
participating PCP clinics will be analyzed every two weeks for data completion 
rates (# completed data sets/total number of possible data sets). De-identified 
aggregate data completion rates will be provided to the site PI and feedback 
will be given to individual PCP clinics through the PCP site champion on a 
biweekly basis. The site PI for each city and the PCP clinic champions will 
meet regularly, using in person and teleconference visits as needed. During 

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these meetings recruitment, enrollment, retention, and data collection rates for 
the previous month and cumulative-to-date will be reviewed for each clinic and 
the city as a whole. Successes and challenges will be discussed in a spirit of 
quality improvement. This approach will allow sharing of best practices, 
successes, and challenges; rapid identification of potential barriers to optimal 
recruitment, retention, and data collection strategies; and rapid Plan-Do-Study-
Act (PDSA) cycling to address barriers.  
 

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11 Participants rights and confidentiality 
11.1 Institutional Review Board (IRB) review  
This protocol and any subsequent modifications will be reviewed and approved by the 
relevant IRB for each study site. The University of Pittsburgh IRB as the IRB of Record 
for the UPMC and Intermountain Healthcare study sites has approved a waiver of 
informed consent/HIPAA authorization to access, record and use protected patient 
health information/patient medical record information for review and analysis of 
medical record data. It has also approved a waiver for the requirement to obtain a 
written informed consent for completion of questionnaires and interviews. Separate 
review and oversight will be conducted by the Boston University Medical Center IRB, 
Johns Hopkins University IRB, and Medical University of South Carolina IRB.  
11.2 Informed consent scripts 
The letter to be mailed to QI participants informing them of the research data collection 
and scripts to be used for obtaining verbal consent are provided in Appendix 7 (6--
month assessments). 
11.3 Participant confidentiality  
Any data, forms, reports, and other records in the study database will be identified only 
by a unique participant identification number (Participant ID or PID) to maintain 
confidentiality.  All hardcopy records will be kept in a locked file cabinet.  All computer 
entry and networking programs will be done using PIDs only.  
11.4 Study discontinuation  
The study may be discontinued at any time by the IRB or PCORI as part of their duties 
to ensure that research participants are protected.  
 
 

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12 Committees 
The following committees will guide the work of this project: 
• 
Steering Committee: made up of the project PI and Co-PI, site PIs, and patient co-
investigators who will participate in monitoring the conduct of the project from its 
inception to the dissemination of the study results. Additional key co-investigators 
and staff from each of the study sites will also participate in Steering Committee 
conference calls and meetings. 
• 
Advisory Board: this board is made up of a team of patient, provider, payer and 
purchaser representatives. The Advisory Board will provide a “safe harbor” for the 
Steering Committee members to review study options and provide input from their 
respective stakeholder perspective. The board will meet face-to-face as well as on 
conference calls and engage in meaningful and inclusive discussions of key issues 
as they emerge, particularly during the formative stages early in the granting period. 
Specifically, it will engage and advise the Steering Committee, be active 
ambassadors for the study, help with organization and planning, and directly 
participate in the dissemination phases the study. 
• 
Dissemination and Publications Committee: this committee will promote, 
facilitate, and monitor TARGET Trial dissemination products and ensure compliance 
with PCORI dissemination policies. 
• 
Data Integrity Committee: this committee will work to harmonize all of the data 
integral to the primary and secondary aims of the study from the five sites. This 
includes creating data dictionaries; data extraction templates, policies, and 
timelines; ensuring secure data housing; and working with the study statisticians to 
ensure the data is ready for analysis. 
13 Publication of research findings 
Publication of the results of this trial will be governed by the policies and procedures 
developed by the Steering and Dissemination Committees.   
 
 

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Hoffmann TC, Del Mar CB, Strong J, Mai J. Patients' expectations of acute low 
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15 Appendix 1: Chronic LBP Questionnaire 
Screening for Chronic Low Back Pain 
1. 
How long has low back pain interfered with your ability to do regular daily activities? 
 
 
Less than 1 month 
 
1 – 3 months 
 
More than 3 months 
 
2. 
Think only about the past 6 months.  How often has low back pain interfered with your 
ability to do regular daily activities? 
 
 
Less than half the days 
 Half the days or more than half the days 
 
 
Definition and questionnaire rules: 
• 
“Chronic” = greater than 3 months (Q1c) + at least half the days (Q2b)  
• 
“Acute” = all else Q1a, Q1b, or Q1c+Q2a 
• 
If patient answers 1a or 1b, stop and patient is acute 
• 
If patient answers 1c, proceed to question 2 
• 
If patient answers 2a, patient is acute 
• 
If patient answers 2b, patient is chronic 
 
 
 
 

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41 
 
16 Appendix 2: STarT Back Tool 
STarT Back Screening Tool for Risk Stratification 
Thinking about the last 2 weeks, check your response to the following questions: 
 
 
Disagree 
 
0  
Agree 
 
 1 
1. My back pain has spread down my leg(s) at some time in the last 2 weeks 
 
 
2. I have had pain in the shoulder or neck at some time in the last 2 weeks 
 
 
3. I have only walked short distances because of my back pain 
 
 
4. In the last 2 weeks, I have dressed more slowly than usual because of my back pain 
 
 
 
5. It’s not really safe for a person with a condition like mine to be physically active 
 
 
6. Worrying thoughts have been going through my mind a lot of the time 
 
 
7. I feel that my back pain is terrible and it’s never going to get any better 
 
 
8. In general I have not enjoyed all the things I used to enjoy 
 
 
9. Overall, how bothersome has your back pain been in the last 2 weeks? 
 
 
 
Not at all 
Slightly 
Moderately 
Very much 
Extremely 
 
 
0 
 
0 
 
0 
 
1 
 
1 
Total Score (all 9): 
Sub Score (Q5–9): 
Scoring System 
 
 Low Risk: 
Total Score = 3 or less 
 
Medium Risk: 
Total Score = 4 or more + Sub Score Q5–9 = 3 or less 
 
High Risk:  
Total Score = 4 or more + Sub Score Q5–9 = 4 or more 
 
 
 

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42 
 
17 Appendix 3: Oswestry LBP Questionnaire 
Oswestry LBP Questionnaire 
This questionnaire is designed to give us information as to how your back (or leg) trouble affects your ability to 
manage in everyday life. Please answer every section. Mark one box only in each section that most closely 
describes you today. 
 
Section 1 – Pain Intensity 
 
I have no pain at the moment. 
 
The pain is very mild at the moment. 
 
The pain is moderate at the moment. 
 
The pain is fairly severe at the moment. 
 
The pain is very severe at the moment. 
 
The pain is the worst imaginable at the moment. 
 
 
Section 2 – Personal Care (washing, dressing, etc.)  
 
I can look after myself normally without causing additional 
pain. 
 
I can look after myself normally but it is very painful. 
 
It is painful to look after myself and I am slow and careful. 
 
I need some help but manage most of my personal care. 
 
I need help every day in most aspects of self care. 
 
I do not get dressed, I wash with difficulty and stay in bed. 
 
Section 3 – Lifting 
 
I can lift heavy weights without additional pain. 
 
I can lift heavy weights but it gives additional pain. 
 
Pain prevents me from lifting heavy weights off the floor 
but I can manage if they are conveniently positioned, e.g. 
on a table. 
 
Pain prevents me from lifting heavy weights but I can 
manage light to medium weights if they are conveniently 
positioned. 
 
I can only lift very light weights. 
 
I cannot lift or carry anything at all. 
 
Section 4 – Walking 
 
Pain does not prevent me from walking any distance. 
 
Pain prevents me from walking more than one mile. 
 
Pain prevents me from walking more than a quarter of a 
mile. 
 
Pain prevents me from walking more than 100 yards. 
 
I can only walk using a cane or crutches. 
 
I am in bed most of the time and have to crawl to the toilet. 
 
Section 5 – Sitting 
 
I can sit in any chair as long as I like. 
 
I can sit in my favorite chair as long as I like. 
 
Pain prevents me from sitting for more than 1 hour. 
 
Pain prevents me from sitting for more than half an hour. 
 
Pain prevents me from sitting for more than 10 minutes. 
 
Pain prevents me from sitting at all. 
 
 
Section 6 – Standing 
 
I can stand as long as I want without additional pain. 
 
I can stand as long as I want but it gives me additional 
pain. 
 
Pain prevents me from standing for more than 1 hour. 
 
Pain prevents me from standing for more than half an 
hour. 
 
Pain prevents me from standing for more than 10 
minutes. 
 
Pain prevents me from standing at all. 
 
Section 7 – Sleeping 
 
My sleep is never interrupted by pain. 
 
My sleep is occasionally interrupted by pain. 
 
Because of pain I have less than 6 hours sleep. 
 
Because of pain I have less than 4 hours sleep. 
 
Because of pain I have less than 2 hours sleep. 
 
Pain prevents me from sleeping at all. 
 
Section 8 – Sex Life (if applicable) 
 
My sex life is normal and causes no additional pain. 
 
My sex life is normal but causes some additional pain. 
 
My sex life is nearly normal but is very painful. 
 
My sex life is severely restricted by pain. 
 
My sex life is nearly non-existent because of pain. 
 
Pain prevents me from having any sex life at all. 
 
Section 9 – Social Life 
 
My social life is normal and causes me no additional 
pain. 
 
My social life is normal but increases the degree of pain. 
 
Pain has no significant effect on my social life apart from 
limiting my more energetic interests, e.g., sport, etc. 
 
Pain has restricted my social life and I do not go out as 
often. 
 
Pain has restricted my social life to home. 
 
I have no social life because of pain. 
 
Section 10 – Traveling 
 
I can travel anywhere without pain. 
 
I can travel anywhere but it gives me additional pain. 
 
Pain is bad but I am able to manage trips over two 
hours. 
 
Pain restricts me to trips of less than one hour. 
 
Pain restricts me to short necessary trips of under 30 
minutes. 
 
Pain prevents me from traveling except to receive 
treatment. 
 
ODI © Jeremy Fairbank 1980. All Rights Reserved. Version 2.1a 

TARGET Trial Protocol (Version 3.0; 09/01/2018) 
 
43 
 
18 Appendix 4: Physical Therapist Checklist 
Thank you for this referral to (Insert Clinic Name)      .   The following is a summary of content areas 
covered (indicated by checked boxes) with this patient during treatment for their acute low back pain, 
based on your initial referral of   /  /    .  
 
Patient Information: 
Patient Name:  
      
HICN:        
DOB:  
  /  /     
Diagnosis Indicating Therapy:  
      
ICD-10 Code:      
 
Referring Physician:  
      
Start of Care Date:  
  /  /     
 
 
 
Progress Content Areas:  
• Communication 
 Active listening (eye contact, paraphrase/repeat back what patient says) 
 Facilitation of self-disclosure, activation philosophy (elicit patient’s concerns, discuss and reassure RE: activity)  
 Patient centered goal-setting / motivational interviewing (connect with patient RE: shared goals) 
• Pain coping skills taught and reinforced 
 Relaxed breathing 
 Adaptive distraction skills (e.g., pleasant place imagery) 
 Balanced statements to counteract unhelpful thinking styles (e.g., pain catastrophizing, all-or-nothing thinking) 
• Activity-based treatment  
 Graded activity (to reduce pain-related activity avoidance) 
 Graded exposure (to reduce fear-related motion avoidance) 
• Physical impairment component – most appropriate classification (from APTA clinical practice guidelines): 
 Acute/subacute LBP with mobility deficits 
 Acute/subacute LBP with movement coordination impairments 
 Acute LBP with related (referred) lower extremity pain 
 Acute/subacute LBP with radiating pain 
• Home exercise program: 
 
 Specific activities integrating pain coping skills (as described above) 
 
 Specific education (e.g., web-based format) 
• Treatment monitoring completed: 
 
Yes 
  
No 
 
Additional comments:       
 
 
 
 
Therapist’s Name: 
 
 
Date: 
   /     /    
(Completed checklist is to be forwarded to office of referring PCP via electronic scan or fax.)           
 

TARGET Trial Protocol (Version 3.0; 09/01/2018) 
 
44 
 
19 Appendix 5: Flow diagram for each regional site  
 
 
Primary care clinics  
identified for study 
Primary care clinics  
randomized to GBC+PIPT 
 
 
 
Patient completes            
STarT Back Tool            
(risk assessment) and       
Oswestry 
 
 
PCP provides GBC 
Acute 
Acute 
Stop 
Chronic
Stop
Chronic 
PCP provides GBC
All risk groups 
 
Patient completes            
STarT Back Tool             
(risk assessment) and       
Oswestry 
Primary care clinics  
randomized to GBC 
Clinic personnel identify patients 
with back pain potentially eligible for 
quality improvement (QI) initiative 
Clinic personnel identify patients 
with back pain potentially eligible for 
quality improvement (QI) initiative 
Patient completes Chronic LBP 
Questionnaire 
Patient completes Chronic LBP 
Questionnaire 
Risk status documented 
in the EMR 
Risk status documented 
in the EMR 
Low/medium risk 
(observational cohort) 
High risk 
(RCT cohort) 
Patient receives 
PIPT 
6-month assessment: Chronic LBP Questionnaire and Oswestry 
12-month assessment:  
Medical resource utilization (excluding MUSC site) 
PCP provides GBC 
and refers to PIPT 
GBC: Guideline-Based Care 
(comparator arm) 
GBC+PIPT: Guideline-Based 
Care plus Psychologically 
Informed Physical Therapy 
(intervention arm) 
LBP: low back pain 
Oswestry: Oswestry LBP 
Questionnaire 
EMR: electronic medical record 
RCT: randomized controlled trial 
PCP: primary care physician 
PT: physical therapy 

TARGET Trial Protocol (Version 3.0; 09/01/2018) 
 
45 
 
20 Appendix 6: Data from electronic medical record 
 
 
 
 
 
Contact information (for 6- and 12-month assessments) 
• 
Name 
• 
Street address 
• 
Electronic mail address 
• 
Telephone number 
 
Baseline sociodemographic variables 
• 
Sex 
• 
Race 
• 
Hispanic ethnicity 
• 
Date of birth 
• 
Height 
• 
Weight 
• 
Body mass index 
• 
Tobacco use 
• 
Comorbid conditions  
• 
Insurance status 
 
Encounters and procedures  
• 
Name of providers 
• 
Primary care visits 
• 
Referrals to specialists (orthopedists, spine surgeons, physiatrists)  
• 
Rehabilitation procedures (physical therapy, occupational therapy, osteopathic 
manipulation, chiropractic manipulation, acupuncture) 
• 
Imaging of spine (radiologic , computed tomography, magnetic resonance) 
• 
Surgical procedures (epidural steroid injections, laminectomy) 
• 
Emergency department visits  
• 
Observation unit stays 
• 
Hospitalizations 
 
Medications prescribed/dispensed 
• 
Non-steroidal anti-inflammatory drugs 
• 
Antidepressants 
• 
Antiepileptic drugs 
• 
Skeletal muscle relaxants 
• 
Opioid analgesics 

TARGET Trial Protocol (Version 3.0; 09/01/2018) 
 
46 
 
21 Appendix 7: Letters from health system to eligible patients (30 
days) 
 
 
 
         Aiming to Improve Low Back Treatment 
 
 
Insert Site-Specific Logo 
           Study Site Project Office 
           Return Address 
 
<<Date>> 
«First_Name» «Last_Name» 
«ADD_LINE_1» «ADD_LINE_2» 
«CITY», «STATE»  «ZIP» 
 
Dear «First_Name» <<Last_Name>>: 
Your primary care doctor’s office, «DEPARTMENT», is participating in a research study 
about back pain (the TARGET Trial) to find out how people like you are doing 6 months after 
a doctor visit for back pain. Because you were recently seen at <DEPARTMENT> for back 
pain, you are eligible for this study. 
In about 5 months, researchers from the University of Pittsburgh will get in touch with you by 
phone or email and ask if you would be willing to complete a short survey (about 5-10 
minutes long) asking if you have any back pain and, if so, how it affects your daily activities.  
• 
You will be paid $15 for completing the survey. 
• 
You do not have to join this research study. Whether or not you decide to complete 
the surveys will not affect your medical care at [insert Study Site] now or in the 
future. 
If you do not want to be contacted for this research study, please call (xxx) xxx-xxxx or 
email targettrial@pitt.edu.  
Dr. [Site PI] is the main person in charge of this research study. If you have any questions or 
concerns about this letter or the study, please call the study team at the number listed above 
or Dr. [Site PI] at xxx-xxx-xxxx.  
Thank you for your consideration. 
Sincerely, 
 
Site-specific signature 
Title 
 
 

TARGET Trial Protocol (Version 3.0; 09/01/2018) 
 
47 
 
Appendix 7 (continued): Letters from health system to eligible 
patients (90 days) 
 
 
 
      Aiming to Improve Low Back Treatment 
Site-Specific Med Center Logo 
           Study Site Project Office 
           Return Address 
 
<<Date>> 
«First_Name» «Last_Name» 
«ADD_LINE_1» «ADD_LINE_2» 
«CITY», «STATE»  «ZIP» 
 
 
Greetings from the TARGET Trial Study Team.  
 
This is a reminder that researchers from <Site Name> will be 
contacting you in about 3 months (by phone or email) to complete a 
brief (5-10 minutes) survey.  
 
The purpose of the survey is to see how you are doing since your visit to 
<DEPARTMENT> on <DATE> for back pain. We are interested in 
learning if you still have any back pain and if it affects your daily activities.  
 
You will receive $15 after completing the survey. 
 
Please note that you do not have to join this study. Whether or not 
you choose to take part in the study will not affect your medical 
care at <Site Name> now or in the future.  
 
 
TARGET Trial Project Office 
 
Phone: xxx-xxx-xxxx 
 
 
 
 
     Email: 
targettrial@xxx.edu 
 
(*) options: University of Pittsburgh for UPMC, Boston Medical Center, Johns 
Hopkins, Intermountain Healthcare, Medical University of South Carolina 
 

TARGET Trial Protocol (Version 3.0; 09/01/2018) 
 
48 
 
Appendix 7 (continued): Letters from health system to eligible 
patients (150 days) 
 
 
 
       Aiming to Improve Low Back Treatment 
     Site-Specific Medical Center Logo 
           Study Site Project Office 
           Return Address 
 
 
<<Date>> 
«First_Name» «Last_Name» 
«ADD_LINE_1» «ADD_LINE_2» 
«CITY», «STATE»  «ZIP» 
 
Dear «First_Name» <<Last_Name>>: 
Your primary care doctor’s office, «DEPARTMENT», is participating in a research study about 
back pain (the TARGET Trial). According to your records, you mentioned having back pain when 
you saw <<Dr. Name>> about 5-6 months ago.  
Researchers from the <<Site Name>> (area code xxx) will be contacting you by phone or 
email in about 2-4 weeks to invite you to complete a 5-10 minute survey. We have included a 
copy of the survey with this letter. The survey will ask if you have any back pain and, if so, how 
it affects your daily activities.  
• 
We are very interested in learning how you are feeling now, even if you no longer have any 
back pain.  
• 
You will be paid $15 for completing the survey. 
• 
You do not have to join this research study. Whether or not you choose to participate or 
complete the study will not affect your medical care at <<Site-specific medical center>> now or 
in the future. 
Before you complete the survey, you will need to agree (consent) to take part in this study. If you 
would like to fill out the enclosed survey now, please check the consent box at the top of the 
survey, complete the survey, and mail it back in the enclosed, self-addressed, stamped envelope. 
You can also use the following link <<xxxxxx>> and complete the questions online.  
If we do not get a mailed survey or online survey from you within the next two weeks, we will 
contact you by phone or email to complete the survey. 
Dr. <<Site PI Name>> is the main person in charge of this research study. If you have any 
questions or concerns about this letter, the survey, or the study, please call the study team at 
<<xxx-xxx-xxxx>> or send an email to targettrial@xxx.edu.  Thank you for your consideration. 
Sincerely,Site-specific signature from Medical Center 
Title 
 

TARGET Trial Protocol (Version 3.0; 09/01/2018) 
 
49 
 
22 Appendix 8: Consent for 6-month assessment 
TARGET Trial Verbal / Electronic Consent at 6 Months 
 
 
Your doctor’s office is participating in the TARGET Trial, a research study about back pain, to 
find out how well people like you are doing 6 months after a visit to their doctor. You are being 
asked to join this research study because you reported having back pain several months ago 
when you saw your doctor. At that time, you were asked some questions about how pain 
interferes with your everyday life. If you agree to be in this study, you will be asked the same 
questions now. A letter about the study, including the survey questions, was mailed to your 
home recently.  
 
The questions will take about 5-10 minutes to answer. The study will not directly benefit you, 
but it may help doctors improve care for patients with back pain in the future. There is no cost 
to you to participate and you will be mailed a $15 debit card in appreciation for your 
participation after completing the survey. It is your choice whether or not to participate. If you 
do participate, you do not need to answer any questions you don’t want to.  
 
This study is classified as minimal risk. There is an unlikely risk that the information you 
provide could be seen by people outside the research study, but every effort will be made to 
keep your information confidential. Dr. [PI Name] at [Study Site Name] is the main person in 
charge of the study. If you have any questions, he can be reached at [PI phone #]. If you have 
any questions about your rights as a research subject or wish to talk to someone other than 
the research team, you may call the University of Pittsburgh Human Subjects Protection 
Advocate toll-free at 866-212-2268.  
 
Do you give your consent to participate in this research? 
 
Yes 
[      ] _ (Provide web-based link for electronic survey, or proceed with interview) 
 
No 
[      ]  Thank you for your time today. 
 
 
If returning survey in enclosed  
envelope, please print name here: ____________________________________ 

TARGET Trial Protocol (Version 3.0; 09/01/2018) 
 
50 
 
23 Appendix 9: Participating study sites and investigators 
Site 1: University of Pittsburgh (Coordinating Center) 
Anthony Delitto, PT, PhD, FAPTA (Project and Site PI) Telephone: 412-383-6631 
Professor and Dean 
Fax: 
412-648-5970 
School of Health and Rehabilitation Sciences 
Email: 
delitto@pitt.edu 
4029 Forbes Tower 
Pittsburgh, PA 15260 
 
Carol Greco, PhD 
Telephone: 412-623-6873 
Assistant Professor of Psychiatry 
Email:  
grecocm@upmc.edu  
School of Medicine 
Thomas Detre Hall 
3811 O’Hara Street 
Pittsburgh, PA 15213 
 
 
Jong-Hyeon Jeong, PhD 
Telephone: 412-624-8549 
Professor and Interim Chair, Department of Biostatistics Email:  
jjeong@pitt.edu  
Graduate School of Public Health 
 
A444 Crabtree, 130 DeSoto Street  
Pittsburgh, PA 15206 
 
Charity Moore Patterson, PhD, MSPH 
Telephone: 412-383-4812 
Professor of Physical Therapy 
Email: cgp22@pitt.edu 
School of Health and Rehabilitation Sciences 
Bridgeside Point 1, 100 Technology Drive, Suite 210 
Pittsburgh, PA 15219-3130 
  
Michael Schneider, DC, PhD 
Telephone: 412-383-6640 
Associate Professor of Physical Therapy 
Email:  
mjs5@pitt.edu  
 
School of Health and Rehabilitation Sciences 
 
Bridgeside Point 1, 100 Technology Drive, Suite 210 
Pittsburgh, PA 15219-3130 
 
 
Gwendolyn Sowa, MD, PhD 
Telephone: 412-648-1091 
Associate Professor and Chair  
Email:  
gas26@pitt.edu 
Department of Physical Medicine and Rehabilitation 
 
School of Medicine 
 
Kaufmann Medical Building 
3471 Fifth Ave., Suite 202 
Pittsburgh, PA 15213 
 
Joel Stevans, PhD, DC 
Telephone: 412-383-6652 
Assistant Professor of Physical Therapy  
Email:  
jms363@pitt.edu  
 
School of Health and Rehabilitation Sciences 
 
Bridgeside Point 1, 100 Technology Drive, Suite 210 
Pittsburgh, PA 15219-3130 
 

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Marie Tamasy, MPIA, PhD 
Telephone: 412-463-4927 
Patient Co-Investigator  
Email:  
tamasymarie@gmail.com 
University of Pittsburgh  
 
 
Ajay Wasan, MD 
Telephone: 412-665-8030 
Professor of Anesthesiology and Psychiatry 
Email:  
wasanad@upmc.edu 
Vice Chair for Pain Medicine 
 
Centre Commons 
5750 Centre Ave., Suite 260 
Pittsburgh, PA 15206 
 
 
Site 2: Boston Medical Center 
Robert Saper, MD, MPH (Project Co-PI and Site PI) 
Telephone: 617-414-6276 
Professor of Family Medicine 
Fax: 
617-414-3345 
Boston University School of Medicine 
Email: 
robert.saper@bmc.org 
Director of Integrative Medicine, Boston Medical Center 
1 Boston Medical Center Pl. 
Dowling 5 South 
Boston, MA 02118 
 
William Adams, MD 
Telephone: 617-414-4233 
Professor of Pediatrics 
Email: 
badams@bu.edu 
Boston University School of Medicine 
 
Director, BU-CTSI Clinical Research Informatics 
88 E. Newton St., Vose Hall 
Boston, MA 02118 
 
Jewel Cash 
Telephone: 857-654-6780 
Patient Co-Investigator 
Email: 
jewelandjewel@yahoo.com 
Boston Medical Center 
 
Katherine Gergen-Barnett, MD 
Telephone: 617-414-2080 
Assistant Professor of Family Medicine 
Email:  
katherine.gergen-barnett@bmc.org 
Boston University School of Medicine 
 
1 Boston Medical Center Pl. 
Boston, MA 02118 
 
Rebecca Mishuris, MD 
Telephone: 617-414-6611 
Assistant Professor of Medicine 
Email: 
rgrochow@bu.edu 
Boston University School of Medicine 
 
801 Massachusetts Avenue, 2nd floor 
25 Buick Street 
Boston, MA 02118 
 
 
 

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Charles Williams, MD 
Telephone: 617-414-2098 
Assistant Professor of Family Medicine 
Email: 
charles.williams@bmc.org 
Boston University School of Medicine 
 
Medical Director, Boston HealthNet 
1 Boston Medical Center Pl. 
Boston, MA 02118 
 
Site 3: Intermountain Healthcare 
Gerard Brennan, PT, PhD (Site PI) 
Telephone: 801-314-2529 
Director, Clinical Quality and Outcomes Research 
Fax:  
801-314-4149 
 
Rehabilitation Services 
Email:  
gerard.brennan@imail.org 
5848 South 300 East 
Murray, UT 84107 
 
Mark Briesacher, MD 
Telephone: 801-442-3495  
Senior Administrative Medical Director  
Email: 
mark.briesacher@imail.org 
Intermountain Medical Group | Central Office 
36 South State Street, 21st floor (Northeast side) 
Salt Lake City, UT 84111 
 
Wayne Cannon, MD 
Telephone: 801-442-2990 
Medical Director Primary Care Clinical Program 
Email: 
wayne.cannon@imail.org 
Intermountain Healthcare | Central Office 
36 South State Street, 21st floor (South side) 
Salt Lake City, UT 84111 
 
Stephen Hunter, DPT, OCS 
Telephone: 801-887-5448 
Administrator, Intermountain Physical Therapy 
Email: 
stephen.hunter@imail.org 
1685 West 2200 South 
Salt Lake City, UT 84119 
 
Scott Lake 
Telephone: 801-505-4288 
Patient Co-Investigator 
Email: 
scottl@msciutah.com  
Intermountain Healthcare 
 
Lee Pierce, MIS 
Telephone: 801-507-8065 
Chief Data Officer 
Email: 
lee.pierce@imail.org 
5171 South Cottonwood Street 
Murray, UT 84107 
 
Raj Srivastava, MD, MPH 
Telephone: 801-442-3417 
Assistant Vice President of Research 
Email: 
raj.srivastava@imail.org 
Intermountain Healthcare 
36 South State Street, Suite 1600 
Salt Lake City, UT 84111 
 

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Site 4: Johns Hopkins University 
Stephen Wegener, PhD, ABPP (Site PI) 
Telephone: 410-502-2441 
Professor of Physical Medicine and Rehabilitation 
Fax: 
410-502-2419 
Director, Division of Rehabilitation Psychology and 
Email: 
swegener@jhmi.edu 
 
Neuropsychology 
The Johns Hopkins School of Medicine 
Phipps Building Room 174 
600 N. Wolfe Street 
Baltimore, MD 21287 
 
Michael Albert, MD 
Telephone: 410-502-8494  
Regional Medical Director 
Email:  
malber11@jhmi.edu 
Johns Hopkins Community Physicians 
1000 East Eager Street 
Baltimore, MD 21213 
 
Akhil Chhatre, MD 
Telephone: 410-614-4030  
Assistant Professor 
Email:  
achhatr1@jhmi.edu 
Johns Hopkins University 
Phipps 174 PMR 
600 North Wolfe Street  
Baltimore, MD 21287 
 
Kelly Daley, PT, MBA 
Telephone: 410-955-4092 
Director of Rehabilitation Informatics and Analytics 
Email:  
kdaley3@jhmi.edu 
Rehabilitation Medicine  
 
Johns Hopkins Hospital 
Osler 159 
1800 Orleans Street 
Baltimore, MD 21287 
 
 
Michael Friedman, MPT, MBA 
Telephone: 443-287-5371 
Director of Rehabilitation Therapy Services 
Email:  
mfried26@jhmi.edu 
Johns Hopkins Hospital, 
Johns Hopkins Physical Medicine and Rehabilitation 
Meyer 1-140 
1800 Orleans St 
Baltimore, MD 21287 
 
 
Site 5: Medical University of South Carolina 
David Morrisette, PT, PhD (Site PI) 
Telephone: 843-792-2940 
Director and Professor, Division of Physical Therapy 
Fax: 
843-792-0710 
Department of Health Professions 
Email: 
morrisdc@musc.edu 
College of Health Professions 
B311 Rutledge Avenue, MSC 962 
Charleston, SC 29425 
 
 

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Kit Simpson, DrPH (Site Co-PI) 
Telephone: 843-792-0760 
Professor  
Email: 
simpsonk@musc.edu 
Department of Healthcare Leadership & Management  
Director, MUSC Comparative Effectiveness Data Analysis Core 
 
151-B Rutledge Avenue, MSC 962 
Charleston, SC 29425 
 
Leslie Lenert, MD, MS 
Telephone: 843-792-1914 
Professor of Medicine  
Email: 
 lenert@musc.edu 
Chief Research Information Officer 
 
135 Cannon Street, Suite 405N 
Charleston, SC 29425 
 
David Louder, MD, MBA 
Telephone: 843-876-2811 
Chief, MUSC Health Alliance 
Email: 
louder@musc.edu 
Chief, Primary Care Integrated Center for Clinical Excellence 
 
MUSC Physicians/College of Medicine 
96 Jonathan Lucas Street, Suite 601-J 
Charleston, SC 29425 
 
Annie Simpson, PhD 
Telephone: 843-792-4493 
 
Associate Professor 
Email: 
 simpsona@musc.edu 
Department of Healthcare Leadership & Management 
151-B Rutledge Avenue, MSC 962 
Charleston, CS 29425