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临床试验/NCT05452876
NCT05452876招募中2 期

Alberta Back Care Pathway (ABCp)

University of Alberta2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年3月31日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
240
试验地点
2
主要终点
Primary Care visits

研究概览

简要总结

Every year, the pain, disability, addiction, and expense associated with LBP increase in Alberta. This escalation is largely because most people with LBP seek care from family physicians who are unable to provide effective, guideline-based interventions due to three recognized barriers: 1) a lack of training, 2) a lack of no (or low) cost access to these interventions and 3) a lack of physician time and reimbursement to deliver these interventions. As a result, most LBP care provided in Alberta is "low-value".

With input from Alberta patients, healthcare providers, administrators and international scientists, the Alberta Back Carepathway (ABCp) was designed to overcome these barriers by giving family physicians a common, guideline-based approach to coordinate, assess and manage LBP patients in day-to-day practice.

The ABCp trains family physicians to quickly and easily place patients into 5 categories each having evidence-based interventions that can be provided by physicians at no or low cost to patients and no net cost to the healthcare system. By designing the ABCp to resolve barriers related to training, access and delivery, the ABCp will "pull" rather than "prod" patients and clinicians toward sustained, long-term implementation of this cost-effective solution.

This study is based on a multi-clinic, controlled, non-randomized stepped-wedge study designed for urban and rural primary care networks (PCNs). The primary outcome will be decreased healthcare resource utilization with secondary improvements in quality of life and opioid consumption. Overall, the savings realized through ABCp will create a self-sustaining, scalable solution for LBP care in Alberta.

详细描述

Justification:

Low back pain (LBP) is a global problem creating more disability than cardiovascular disease and cancer.

In Canada, many people with LBP seek care from general practitioners (GPs) whose services are fully funded by public health programs. Although "free" to Canadians, most approaches used by physicians to address LBP are of low-value - they are often ineffective and potentially dangerous. While research shows that effective LBP interventions are currently available including education, therapeutic exercise, reassurance, manual therapy and non-opioid medications, most LBP patients don't receive these more effective approaches because of their cost (they are not fully funded by public health care) and their GPs are not trained to deliver them. As a result, most LBP patients receive ineffective care that creates 1) unnecessary pain, ongoing disability and potential painkiller addiction, 2) misuse of limited health resources and 3) systemic de-integration of community clinicians who provide evidence-based care for LBP, but are not funded by the current health care system (e.g. Chiropractors and Physical Therapists). To overcome the increasing provision of low-value care for LBP in Canada, the Alberta Back Care pathway has been created (ABCp). The ABCp incorporates GLA:D Back programming (Good Life with Osteoarthritis: Denmark) the elements of which include patient education, structured exercise and data collection. This new program provides evidence-based care at no cost to the patient through innovative decision-making tools that de-medicalize LBP care.

Objectives:

The primary objective is to evaluate the cost-saving performance measures, described by three economic indicators known to be influenced by evidence-based care for LBP. These include 1) the number of LBP visits to family physicians, 2) the number of family physician referrals of LBP patients to specialists and 3) the number of LBP imaging requests from family physicians.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Licensed physicians in the Edmonton West Primary Care Network (EWPCN) and the Calgary Chronic Pain Centre (CPC)
  • Age ≥18 years; (no upper age limit)
  • English speaking and a resident of Alberta who have cognition and language sufficient to understand written information, and to provide consent.
  • Cauda equina syndrome or infection, fracture
  • Single or multiple items such as age over 70, female, significant trauma, and prolonged corticosteroid use)
  • Cancer (single or multiple items such as older age, and previous history of cancer)
  • For the CPC site specifically: additional requirement of depression and anxiety as rated using the PHQ4 exclusion will include score of 3 or greater on the first two questions combined and/or score of 3 or greater on the third and 4th question combined

排除标准

  • Low back pain is caused by a recent motor vehicle accident
  • Any known contraindication to exercise (i.e., unstable angina, uncontrolled arrhythmia, severe aortic stenosis).
  • Current participation in a supervised exercise or rehabilitation program or enrolled in another interventional clinical trial.
  • Plans for, or undergoing, surgery that would involve the spine directly or indirectly or place them into a position where any of the interventions in this trial would be contraindicated as a result of the surgery.

结局指标

主要结局

Primary Care visits

时间窗: Through study completion, an average of 30 months

Number of GP revisits for LBP

次要结局

  • GP ordered LBP imaging(Through study completion, an average of 30 months)
  • GP requested specialist consultations(Through study completion, an average of 30 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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