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临床试验/NCT02777983
NCT02777983已完成不适用

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

Brooke Army Medical Center2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
2
主要终点
Healthcare Utilization

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Education Group

Experimental

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.

干预措施: Educational Video App (Behavioral)

Usual Care Group

No Intervention

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.

结局指标

主要结局

Healthcare Utilization

时间窗: 6 months

This will include an a frequency count of diagnostic imaging orders and types, specialty referrals, and medication use (primarily prescription opiates).

次要结局

  • Patient Reported Outcomes Measurement Information System 29 Item Subscale (PROMIS-29)(0, 1, 6 months)
  • Keele STarT Back Screening Tool (SBST)(0, 1, 6 months)
  • Optimal Screening for Prediction of Referral and Outcome Yellow Flags assessment tool (OSPRO-YF)(0, 1, 6 months)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Dan Rhon

Director of Physical Therapy, Center for the Intrepid

Brooke Army Medical Center

研究点 (2)

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