What was the research about?
Back pain is a common problem that makes it hard for people to work, move around, or take care of themselves and their families. The STarT Back strategy is a computer-assisted program that doctors and physical therapists can use to identify treatment options appropriate for patients’ risk for ongoing back pain.
In this study, the research team wanted to learn if using the STarT Back strategy helped improve patients’ back pain and ability to move. The team compared patients in clinics that used STarT Back with patients in clinics that didn’t use it.
What were the results?
The study found no differences in patient outcomes or in use of appropriate treatments between patients in clinics that used STarT Back and patients in clinics that didn’t use it.
Who was in the study?
The study included 1,701 patients in Washington State. Of these, 79 percent were white, and 48 percent were over age 60. All patients had back pain without a specific cause, such as an injury.
What did the research team do?
The research team assigned three clinics, by chance, to use the STarT Back strategy and three clinics not to use it. The STarT Back strategy included a questionnaire that patients answered to estimate their risk of ongoing back pain. In the clinics that used the STarT Back strategy, doctors or physical therapists entered patients’ answers to the questionnaire. The program used the answers to predict whether patients would have a low, medium, or high risk of ongoing, disabling pain that would keep them from being able to move around easily. The program also recommended treatment options appropriate for each patient’s level of risk. The doctor could then talk with the patient about the treatment options. Clinic staff used STarT Back for about 50 percent of visits related to low back pain. The clinics that didn’t use STarT Back treated patients with low back pain as they usually did.
Next, the team asked patients about their back pain two weeks after their first doctor’s visit and again two and six months later.
People in the community with experience with chronic pain and primary care doctors worked with the research team during this study.
What were the limits of the study?
Patients had started treatment when the research team first asked about their back pain. As a result, patients’ responses may not accurately reflect the effects of using STarT Back compared with usual care. The team studied only one healthcare system in Washington State. The results may be different for other clinics or locations.
Future research could look at ways to make sure doctors use the STarT Back questionnaire with all patients and then recommend appropriate treatments for patients in each risk category.
How can people use the results?
Researchers can look at other ways to help patients with low back pain get appropriate treatments based on their risk of ongoing pain and distress.
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
|Design||Randomized controlled trial|
|Population||1,701 patients with nonspecific low back pain at 6 primary care clinics in Washington State|
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.
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).
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.
Final Research Report
View this project's final research report.
Results of This Project
Related Journal Citations
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Reviewers’ comments and the investigator’s changes in response included the following:
- The awardee addressed reviewers’ confusion about the timing of this study in the context of a larger, system-wide initiative to change low back pain care within Group Health Cooperative (now Kaiser Permanent Washington). The awardee explained that the dissemination of the system-wide initiative was passive. The investigator noted that the initiative was not mandatory but it represented usual care in the comparison clinics. The awardee explained that it implemented the quality improvement intervention, STarT Back, only in the three study clinics, which required training for physicians and other staff.
- In response to reviewer questions, the awardee explained that stakeholder engagement was influential in deciding on outcome measures and messaging for study participants but was not a factor in the design of the study. The awardee noted that the stakeholders did not have expertise in study design.
- The reviewers noted that the 12-day span between participants’ study entry and baseline data collection could have allowed for patients to improve before the collection of baseline data, resulting in the intervention’s small effect size. The awardee acknowledged this as a limitation of the study.
- The reviewers asked the awardee to add information to the background and discussion sections describing similarities and differences between the current study and a previous study of the same intervention in the United Kingdom. The awardee posited possible reasons that patients receiving the intervention showed improvement in the United Kingdom but not in the United States. The investigator based its reasoning on differences in healthcare structure in the two countries. The awardee also noted that the UK intervention primarily focused on physical therapy, rather than the multiple treatment options in the current study. The awardee also noted that in the current study, patients had more disability related to low back pain than patients did in the UK study.
Conflict of Interest Disclosures
Study Registration Information
^Group Health Cooperative was aquired by Kaiser Permanente in February 2017.
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