Professional Abstract

Objective

To evaluate the effect of implementing the STarT Back strategy for categorizing and treating patients at low, medium, and high risk of persistent low back pain in primary care clinics on patients’ physical function and pain severity

Study Design

Design Element	Description
Design	Randomized controlled trial
Population	1,701 patients with nonspecific low back pain at 6 primary care clinics in Washington State
Interventions/ Comparators	STarT Back strategy includes a tool used by providers to estimate the risk of a patient’s continued problems with low back pain and recommendations for treatment options based on that risk Usual care
Outcomes	Primary: patient-reported ratings of back-related functional limitations and back pain severity over the past 7 days Secondary: patient-reported symptoms of depression and anxiety, fear of movement, global improvement, self-efficacy, satisfaction, work productivity, activity impairment, use of back-related medications, and exercise; use of healthcare services
Timeframe	6-month follow-up for primary outcome

This randomized controlled trial compared the STarT Back strategy with usual care. The study took place in six clinics in Washington State and had four phases: a control data collection period with no intervention in all sites, a training phase in the intervention clinics, an active treatment period in the intervention clinics with no intervention in the control clinics, and a postintervention data collection period. The team randomly assigned three clinics to adopt the intervention and three clinics to maintain usual care.

The STarT Back tool uses patient responses to a nine-item questionnaire to allocate patients to a low-, medium-, or high-risk subgroup according to their risk of persistent low back pain. Clinicians at the intervention clinics entered patient responses to the questionnaire directly into the electronic health record (EHR) during the clinic visit. The EHR assigned patients to a risk subgroup and displayed the recommended treatment options for that subgroup on a screen visible to patients and clinicians and gave them an opportunity to discuss the information. At the usual care clinics, clinicians continued to provide standard care for low back pain.

A total of 2,138 patients with a primary diagnosis of nonspecific low back pain visited the intervention clinics and 2,571 visited the control clinics. Researchers collected patient-reported outcomes data by phone two weeks after the doctors’ visits and again two and six months later. Overall, 1,701 patients provided baseline outcomes data. Of these, 79% were white, and 48% were over age 60. Researchers also measured healthcare utilization over the six-month period for all patients who visited the control and intervention clinics.

Community members with personal experience with chronic pain and primary care clinicians from the healthcare system worked with researchers regularly throughout the study.

Results

Clinicians in the three intervention clinics entered data from the STarT Back questionnaire for about 50% of visits related to low back pain. The tool indicated that 41% of patients had a low risk for persistent back problems, 37% had a medium risk, and 22% had a high risk.

Compared with usual care, the STarT Back strategy had no significant effects on primary or secondary outcomes. The study found no evidence that the intervention increased the use of treatments recommended for medium- and high-risk patients (e.g., physical therapy, complementary and alternative medicine, or cognitive behavioral therapy) or decreased the use of nonrecommended tests or treatments for patients at any risk level (i.e., imaging, opioid medications, spine injections, or surgical referrals).

Limitations

Researchers collected baseline data two weeks after the start of treatment. As a result, treatment effects may have masked the effects of the intervention compared with usual care. Only 36% of eligible patients agreed to participate in the study. Results may have differed if a higher proportion of eligible patients had participated. The study took place within one healthcare system in Washington State. Results may differ for other clinics or locations.

Conclusions and Relevance

The STarT Back strategy to support stratified care for low back pain had no effect on patient outcomes or healthcare use in this study.

Future Research Needs

Future research could explore strategies for increasing clinician use of the STarT Back tool and referral of patients to evidence-based treatments appropriate for their risk levels.