THEMAS Team, TIMC-IMAG Laboratory, UMR CNRS-UGA, Grenoble, 5525, France.
Department of Physiotherapy, Faculty of Medicine, University Grenoble-Alpes, Grenoble, France.
BMC Health Serv Res. 2024 Nov 18;24(1):1427. doi: 10.1186/s12913-024-11814-2.
A new model of care enables French physiotherapists (PT) working in collaboration with family physicians (FP) to expand their usual scope of practice for patients with acute low back pain (LBP). The aim of our study is to evaluate the impact of this new first-contact physiotherapy (FCP) advanced practice model compared to usual FP care.
A multicentre pragmatic non-inferiority cluster randomised controlled trial (RCT) has been conducted in six multidisciplinary primary healthcare centres in France. Patients from 20 to 55 years old with acute LBP consulted either the PT or the FP. PT independently assessed and managed patients including medication prescription. The primary outcome measure was disability at six weeks (Roland Morris Disability Questionnaire, range 0-24). Secondary outcomes include pain, risk disability prognosis, satisfaction with care, healthcare resources use and wait times. Data were collected at baseline, six and twelve weeks. Outcomes across arms were compared using mixed models regression analysis. Except for non-inferiority analysis of the primary outcome measure, other analyses were performed with a two-sided significance level of 0.05.
Sixty patients were recruited (PT: 32, FP: 28). The adjusted mean difference between groups for disability at 6 weeks was 0.39 in favour of the FP group (95%CI: -2.03; 2.81, p = 0.753). Considering a 5 points minimal clinically important difference, the FCP-led model of care was not inferior to usual FP care for the primary outcome. There was no statistically significant difference between groups in disability at 3 months and pain at 6 weeks and 3 months. PTs prescribed significantly less medications than FPs (p < 0.001). No statistically significant difference was found for other healthcare resource use outcomes, patients' satisfaction and wait times.
This is the first RCT to evaluate the impact of a FCP advanced practice model of care including medical delegated acts in a primary care setting. Our results suggest that the FCP-led model of care is not inferior to usual FP care regarding disability at 6 weeks. The FCP model could result in possible benefits in terms of healthcare resources use. Further adequate powered studies with larger sample size are needed to draw stronger conclusions.
The study has been registered in ClinicalTrials.gov (NCT05200533) on the 20th of January 2022.
一种新的护理模式使法国物理治疗师（PT）能够与家庭医生（FP）合作，扩大其对急性腰痛（LBP）患者的常规实践范围。我们研究的目的是评估这种新的一线物理治疗（FCP）高级实践模式与常规 FP 护理相比的影响。
在法国六个多学科初级保健中心进行了一项多中心实用非劣效性聚类随机对照试验（RCT）。年龄在 20 至 55 岁之间的急性 LBP 患者咨询 PT 或 FP。PT 独立评估和管理患者，包括药物处方。主要结局测量指标是六周时的残疾程度（Roland Morris 残疾问卷，范围 0-24）。次要结局包括疼痛、残疾风险预测、护理满意度、医疗资源使用和等待时间。在基线、六周和十二周时收集数据。使用混合模型回归分析比较各组的结局。除了主要结局指标的非劣效性分析外，其他分析均采用双侧显著性水平 0.05。
共招募了 60 名患者（PT：32 名，FP：28 名）。调整后的组间残疾差异在 6 周时为 0.39，有利于 FP 组（95%CI：-2.03；2.81，p=0.753）。考虑到 5 分的最小临床重要差异，FCP 领导的护理模式在主要结局方面不劣于常规 FP 护理。在 3 个月时的残疾和 6 周和 3 个月时的疼痛方面，两组之间没有统计学上的显著差异。PT 开具的药物明显少于 FP（p<0.001）。其他医疗资源使用结局、患者满意度和等待时间方面无统计学差异。
这是第一项评估包括初级保健环境中医疗委托行为的 FCP 高级实践护理模式对护理的影响的 RCT。我们的研究结果表明，在 6 周时，FCP 领导的护理模式在残疾方面不劣于常规 FP 护理。FCP 模式可能在医疗资源使用方面具有潜在的益处。需要进一步进行具有更大样本量的适当、有力的研究，以得出更有力的结论。
该研究于 2022 年 1 月 20 日在 ClinicalTrials.gov（NCT05200533）注册。
