Validation of the STarT Back Screening Tool in Primary Care Management of Back Pain in the Military Health System: A Randomized Trial of Risk-stratified Care

Background: The management of low back pain (LBP) imposes significant economic burden on individuals, healthcare delivery systems, and society. Total annual direct healthcare costs in the United States incurred by patients with LBP were estimated at 90 billion dollars in 1998, 60% higher than costs for individuals without LBP. Increasing amounts of research point to the importance of even the earliest care decisions made about the management of patients with LBP towards predicting the outcomes of care including work readiness and the likelihood of utilization of high-cost procedures. A novel approach is to determine whether stratified care according to the estimated risk of poor prognosis improves clinical outcomes. The STarT Back Screening Tool (SBST) does precisely this, classifying patients into one of three risk categories (low, medium, and high) for targeted treatment based on the presence of modifiable physical and psychological indicators of persistent, disabling symptoms. Recent studies have shown improved outcomes and significant costs saving associated with using the tool in primary care settings. However, it is unknown whether a similar stratified care approach will achieve similar results in the primary care management of patients with LBP in the Military Health System (MHS).

Objective/Hypothesis: The purpose of this study is to validate the clinical and cost-effectiveness of the SBST in the primary care management of patients with LBP in the MHS. The overall hypothesis is that, for patients seeking care for LBP, treatment decisions based on risk stratification will result in significantly better long-term outcomes and decreased overall healthcare utilization compared to the usual care method of making treatment decisions.

Specific Aims:

Specific Aim 1: Compare clinical outcomes between risk-stratified care according to the SBCT and usual care in patients with LBP.

Specific Aim 2: Compare direct and indirect costs associated with risk-stratified versus usual care in patients with LBP.

Specific Aim 3: Compare the cost-effectiveness of risk-stratified care versus usual care.

Study Design: Multi-site randomized controlled trial.

Relevance: A relatively small percentage of patients with LBP will develop chronic disability; however, these individuals account for a disproportionate share of healthcare expenditures. Most clinical practice guidelines recommend only advice and education for all patients with nonspecific LBP during the initial weeks of management, with consideration of psychosocial factors and referral to physical therapy recommended only when recovery is delayed. Psychosocial factors have been identified as risk factors that act as 'obstacles to recovery' and increase the risk of developing chronic disability. Therefore, targeted management strategies (risk-stratified care) initiated immediately upon initial consultation in primary care may be more cost-effective than delaying treatment (usual care) for some patients. If these results could be validated within this setting, then this simple-to-use screening strategy could be implemented practically and efficiently across the MHS, with the expectation that this would also come with substantial cost savings and lower disability among its beneficiaries that suffer from LBP.

Patients within the MHS that receive stratified care utilizing the SBST may demonstrate the same improvements in disability and increased quality of life, while also exhibiting lower healthcare costs as has been shown in other medical settings. One of the limitations of the SBST trial's study design was that there was no standardization of the physical therapy interventions that were delivered. Therefore, it's difficult to ascertain whether the favorable outcomes in the risk stratified group are attributable to superior physical therapy intervention or the overall effectiveness of the stratification process in directing the right patients to physical therapy with or without psychological augmentation. It is also unknown whether a similar stratified care approach will achieve similar results in the primary care management of patients with LBP in the MHS.