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临床试验/NCT05200533
NCT05200533Unknown不适用

Task-sharing and Shifting Model Between Family Physicians and Physiotherapists for Acute Low Back Pain Patients: a Pragmatic Cluster Randomized Controlled Trial

University Hospital, Grenoble6 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2022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
发起方
入组人数
195
试验地点
6
主要终点
Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks

研究概览

简要总结

Background: The aging population and the rising prevalence of musculoskeletal disorders increase resort to primary care services. Models of care integrating task sharing and shifting (TS/S) can help face challenge of access to care by strengthening the role of healthcare professionals. In France, a new TS/S model is being implemented between family physicians (FPs) and physiotherapists (PTs) for acute low back pain (LBP) patients' care. The aim of this study is to evaluate the effect of this new model of care on patient clinical outcomes, healthcare resources use and patient satisfaction.

Design: Pragmatic cluster randomized controlled trial

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
None

盲法说明

Data analysis will be blinded.

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients from 20 to 55 years old
  • •Suffering from acute low back pain since less than 4 weeks
  • •Able to understand and speak French
  • •Whose family physician is included in the task-sharing and shifting model (only in the intervention group)

排除标准

  • •Protected patient according to the public health regulation,
  • •Patient unable to fill the survey,
  • •Non-availability of the physiotherapist to receive the patient (only in the intervention group)

研究组 & 干预措施

Task-sharing and shifting

Experimental

In the task-sharing and shifting group, family physicians shifted acute low back pain consultations to physiotherapists. Patients with acute low back pain are seen by the physiotherapist instead of family physician. Physiotherapist diagnose acute low back pain, identify red and yellow flags, prescribe sick leave and medications and can refer the patient to additional physical therapy treatment.

干预措施: Task-sharing and shifting model between family physicians and physiotherapists (Other)

Usual care

Active Comparator

In the usual care group, patients with acute low back pain are seen by their family physician.

干预措施: Usual care (Other)

结局指标

主要结局

Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks

时间窗: 6 weeks after the initial consultation

Rolland Morris Disability Questionnaire It is a 24 points scale. The lower score is 0, the higher score is 24. Higher scores mean worse outcomes as the disability level is higher.

次要结局

  • Effect of the TS/S model on acute LBP patient's pain at 6 weeks and 3 months(6 weeks and 3 months after the initial consultation)
  • Effect of the TS/S model on acute LBP patient's satisfaction(Few minutes after the initial consultation (less than one hour))
  • Effect of the TS/S model on acute LBP patients' disability at 3 months(3 months after the initial consultation)
  • Effect of the TS/S model on healthcare resources use(Initial consultation, 6 weeks and 3 months after the initial consultation)
  • Effect of the TS/S model on acute LBP patient's psychosocial risk factors at 6 weeks and 3 months(6 weeks and 3 months after the initial consultation)
  • Effect of the TS/S model on acute LBP patient's wait time before the initial consultation(Initial consultation)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (6)

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