MOBile Instruction for Low Back Pain (MOBIL)

Study Overview
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Brief Summary
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The purpose of this project is to measure the impact of a short educational session on outcomes for patients consulting in primary care for low back pain. Subjects will be patients consulting to their primary care provider for a primary complaint and new episode of low back pain. Subjects will be randomized to receiving the educational tool versus usual care (information only without an educational component) in the clinic immediately prior to seeing their PCP. Patients will be followed for a 6-month period, and outcome measures will be collected and compared across both groups.

Detailed Description
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Patients that arrive for an initial evaluation for low back pain will be randomized to either receive the video education via an application (app) on a tablet computer, or usual care (which consists of information in the form of a handout but no further education prior to seeing the Primary Care Provider - PCP). To control for exposure to the tablet computer, subjects in both groups will use the tablet computer to fill out the self-reported outcome measures. This will all take place while the patient is waiting to see their PCP, who will be blinded to the educational intervention that the patient received. After enrollment and completion of baseline outcome measures and surveys, the subject will be randomized to one of the 2 arms, receive the intervention, and then proceed to have their appointment with their PCP. The appointment with the PCP will proceed per usual care standards, with no additional research interventions. The subjects will be contacted for a follow-up at 1 and 6 months for assessment of self-reported outcomes measuring pain, function, and disability. The investigators will also abstract healthcare utilization from claims data and compare variables of healthcare use between both groups over the 6-month period following enrollment (radiographs, MRIs, prescription opioids, and specialty referrals).

Official Title
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Brief Mobile Education at the Point of Care to Influence Healthcare Decisions Related Low Back Pain Management in Primary Care

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Educational Video App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A Tricare beneficiary with a primary complaint of low back pain consulting in a primary care clinic Between the age of 18 - 50 years Read and speak English well enough to interact with the mobile education technology, provide informed consent and follow study instructions Exclusion Criteria: History of prior surgery to the lumbosacral spine Medical red flags of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease Known current pregnancy or history of pregnancy in the last 6 months Already seen in primary care for an episode of low back pain within the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education Group<br>This will consist of a 6-minute educational video app created and delivered within an application (mobile app) that will be interactive in nature, asking multiple-choice questions at the end to help reinforce key points of the video message. It will include self-management guidance based on evidence related to activity, exercise, and other behavioral components known to influence the prognosis of low back pain. Subjects will also receive the 1-page general conditioning handout that the usual care group will receive. | Behavioral: Educational Video App<br>* The content of the app will be grounded in a biopsychosocial model and modeled on the Back Book, a booklet developed to help modify beliefs and behavior of patients with LBP. Essentially this will take the primary concepts and ideas often given in print or verbal form, and present it in a more engaging and dynamic fashion.<br>* Other names: Mobile Technology Education;|
| No Intervention: Usual Care Group<br>Subjects randomized to usual care will receive a 1-page generic informational handout on general conditioning recommended for low back pain, in addition to whatever education the subject's PCP decides to provide. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare Utilization | This will include an a frequency count of diagnostic imaging orders and types, specialty referrals, and medication use (primarily prescription opiates). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes Measurement Information System 29 Item Subscale (PROMIS-29) | The PROMIS 29-item short form efficiently assesses several outcomes important to patients with a neuromusculoskeletal injury, including pain intensity and interference, sleep disturbance, anxiety, depression, fatigue, and social role participation using items developed with rigorous methodology and patient input. The PROMIS-29 scores have been found valid for patients with orthopedic injuries with minimal clinically important change thresholds of 2-4 points for most scales. It has also been used to successfully measure psychosocial resiliency in patients with disability. | 0, 1, 6 months | 
| Keele STarT Back Screening Tool (SBST) | The Keele STarT Back Screening Tool classifies patients into one of three risk categories (low, medium, and high) for targeted treatment, based on the presence of potentially modifiable physical and psychological prognostic indicators for persistent, disabling symptoms, identified through 9 questions. Patients are classified as low risk of future disabling LBP if they score positively on fewer than 4 questions. The remainder are then subdivided into medium risk (physical and psychosocial indicators for poor outcome, but without high levels of psychological indicators) and high risk (high levels of psychological prognostic indicators with or without physical indicators). | 0, 1, 6 months | 
| Optimal Screening for Prediction of Referral and Outcome Yellow Flags assessment tool (OSPRO-YF) | Measures of psychosocial risk factors taken early after injury and sequentially over time represent an important and relevant clinical necessity, as psychosocial risk factors can vary over time. Some preliminary work on how sequential assessment may improve predictive capabilities has been performed. In previous studies of the SBST, baseline risk status was compared to prediction from 4-week risk status, and 4-week change in risk status for prediction of 6 month pain and disability outcomes following low back pain. The results indicated that prediction improved when 4-week risk status or 4-week change in risk status was incorporated into predictive models. In particular, those with worsened 4 week change in psychosocial risk status (i.e. increasing pain associated distress) had notably worse 6 month outcomes. This provides promising preliminary data for investigating how these change patterns influence patient outcomes in patients with low back pain. | 0, 1, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient education, low back pain, technology