Clinical trial NCT02777983: MOBile Instruction for Low Back Pain (MOBIL)
Official title: Brief Mobile Education at the Point of Care to Influence Healthcare Decisions Related Low Back Pain Management in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: patient education
low back pain
technology
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2016-05-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: Inclusion Criteria:

1. A Tricare beneficiary with a primary complaint of low back pain consulting in a primary care clinic
2. Between the age of 18 - 50 years
3. Read and speak English well enough to interact with the mobile education technology, provide informed consent and follow study instructions

Exclusion Criteria:

1. History of prior surgery to the lumbosacral spine
2. Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease
3. Known current pregnancy or history of pregnancy in the last 6 months
4. Already seen in primary care for an episode of low back pain within the last 3 months

Primary outcomes:
measure: Healthcare Utilization
timeFrame: 6 months
Secondary outcomes:
measure: Patient Reported Outcomes Measurement Information System 29 Item Subscale (PROMIS-29)
timeFrame: 0, 1, 6 months
measure: Keele STarT Back Screening Tool (SBST)
timeFrame: 0, 1, 6 months
measure: Optimal Screening for Prediction of Referral and Outcome Yellow Flags assessment tool (OSPRO-YF)
timeFrame: 0, 1, 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center; Baylor University
name: Daniel Rhon, DPT, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
citation: George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Brief psychosocial education, not core stabilization, reduced incidence of low back pain: results from the Prevention of Low Back Pain in the Military (POLM) cluster randomized trial. BMC Med. 2011 Nov 29;9:128. doi: 10.1186/1741-7015-9-128.
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citation: Godges JJ, Anger MA, Zimmerman G, Delitto A. Effects of education on return-to-work status for people with fear-avoidance beliefs and acute low back pain. Phys Ther. 2008 Feb;88(2):231-9. doi: 10.2522/ptj.20050121. Epub 2007 Dec 4.
citation: Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. doi: 10.1097/00007632-199912010-00010.
citation: Cherkin D, Deyo RA, Berg AO. Evaluation of a physician education intervention to improve primary care for low-back pain. II. Impact on patients. Spine (Phila Pa 1976). 1991 Oct;16(10):1173-8. doi: 10.1097/00007632-199110000-00008.
citation: Moore JE, Von Korff M, Cherkin D, Saunders K, Lorig K. A randomized trial of a cognitive-behavioral program for enhancing back pain self care in a primary care setting. Pain. 2000 Nov;88(2):145-153. doi: 10.1016/S0304-3959(00)00314-6.
citation: Rhon DI, Mayhew RJ, Greenlee TA, Fritz JM. The influence of a MOBile-based video Instruction for Low back pain (MOBIL) on initial care decisions made by primary care providers: a randomized controlled trial. BMC Fam Pract. 2021 Oct 9;22(1):200. doi: 10.1186/s12875-021-01549-y.