Overview
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 progression 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 provider (PCP), this study will compare common, pragmatic, evidence-based, and patient-centered approaches emanating from the primary care environment to reduce the proportion of people with acute LBP who progress to chronic LBP and improve functional abilities.
The question this study will address is:
For patients with acute LBP deemed high risk to progress to chronic LBP, does prompt referral to psychologically informed physical therapy (PIPT) reduce the rate of progression to chronic LBP and improve functional abilities?
To answer this question, we will conduct a pragmatic cluster RCT with 3,000 "high risk" acute LBP patients to compare:
- A Guideline-Based Care (GBC) arm in which pain management decisions are made between primary care providers (PCPs) and patients using the guidance of best evidence but with no specific directives; and
- A Guideline-Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) arm in which PCP care is enhanced with a prompt referral to physical therapy that includes psychologically-informed coaching directed towards education and reduced fear of movement.
A secondary, prospective, observational cohort study will be conducted for those patients presenting with acute LBP who are at "low" or "medium risk" for progression to chronic LBP (N=9,000). Both cohorts will receive follow-up calls at 6 and 12 months to assess for the presence of LBP and functional status.
TARGET is considered a pragmatic trial. Pragmatic trials are designed to evaluate interventions in "real-life" settings with a broad patient population. Pragmatic trials produce results that can be generalized and readily used to improve patient care in routine practice.
TARGET Trial Team
The Steering Committee includes the lead investigators and patient investigators from each of the five national sites.
The Advisory Board is a team of patient, provider, payer, and purchaser representatives. The Advisory Board provides a “safe harbor” for the Steering Committee members to review study options and provide input from their respective stakeholder perspective. The board meets face-to-face or via conference calls annually. Specific roles of the board are to 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. Click here to read more about this team.
The Data Integrity Committee is responsible for harmonizing 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. Click here to read more about this team.