Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic Low Back Pain and Patients at Risk of Chronic Low Back Pain in Primary Care: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Disability at 3 months
研究概览
简要总结
Low back pain is a public health problem with major individual and socio-economic repercussions. In primary care, strong disparities are observed in the management of low back pain patients. While general practitioners (GPs) and physiotherapists appear as two essential first-line caregivers, collaboration between these professionals remains underdeveloped, most often characterized by a lack of consultation or coordination. Systematic increased interprofessional collaboration is likely to improve the results of the care pathway, by optimizing the existing care offer.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients between the ages of 18 and 65
- •Patients consulting their GP for a first or new eisode of acute low back pain (more than 12 months from the previous one) with a STarT Back screening tool score greater than
- •OR low back pain at risk of chronicity (presence of yellow flags, according to the recommendation of the High Health Authority (HAS) of 2019
- •OR recurrent low back pain: in the event of recurrence of low back pain within 12 months after the previous episode, then considered to be at risk of chronicity
- •OR having chronic low back pain (low back pain for more than 3 months)
- •Patients benefiting from the general social security system
- •Patients who understand and speak French fluently
- •Patients who have given their consent after having received complete information on the protocol
排除标准
- •Minor patients
- •Pregnant women (declared pregnancy) or immediately postpartum (up to 3 months)
- •Patients with "red flags" (serious neurological impairment, cancer, infection, fracture or inflammatory disease), according to the 2019 HAS recommendation
- •Patients referred immediately for imaging or specialist advice during the first consultation with the GP (suspicion of underlying pathology)
- •Patients with no history of acute low back pain, at low risk of chronicity (STarT Back screening tool score less than or equal to 3)
- •Patients with a contraindication to rehabilitation by physiotherapy
- •Patients who have already undergone spine surgery
- •Patients with cognitive impairment
- •Patients whose life expectancy is less than 12 months
- •Patients under guardianship or curatorship, under judicial protection or safeguard of justice
- •Patients not affiliated to the general social security system
- •Patients with difficulties in understanding the French language
- •Patients with an inability to give express consent
研究组 & 干预措施
Control
without modification of the usual follow-up
Interventional
Trainig of GP and physiotherapist at collaborative coordinated care pathway
干预措施: collaboration general practitioner and physiotherapist (Procedure)
结局指标
主要结局
Disability at 3 months
时间窗: 3 months
Absolute change in overall Oswestry Disability Index (ODI) scale score between 0 and 3 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability).
次要结局
- Health-related quality of life at 3 months(3 months)
- Evaluation of the course of care: number of consultations(12 months)
- Evaluation of effective collaborative practices(12 months)
- Disability at 12 months(12 months)
- Health-related quality of life at 12 months(12 months)
- Evaluation of the course of care: compliance(12 months)
- Evaluation of the course of care: medical imaging(12 months)
- Evaluation of the course of care: total cost(12 months)