Physiotherapists as first-contact practitioners for patients with low back pain in French primary care: a pragmatic cluster randomised controlled trial.

IF 2.7 3区 医学 Q2 HEALTH CARE SCIENCES & SERVICES BMC Health Services Research Pub Date : 2024-11-18 DOI:10.1186/s12913-024-11814-2
Amélie Kechichian, François Desmeules, Pauline Girard, Hugo Terrisse, Céline Vermorel, Nicolas Pinsault
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Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Trial registration: The study has been registered in ClinicalTrials.gov (NCT05200533) on the 20th of January 2022.

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物理治疗师作为法国基层医疗机构腰背痛患者的首诊医生:一项实用分组随机对照试验。
背景: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,扩大他们对急性腰背痛(LBP)患者的常规诊疗范围。我们的研究旨在评估这种新的首次接触物理治疗(FCP)高级实践模式与家庭医生常规护理相比所产生的影响:方法:我们在法国的六个多学科初级保健中心开展了一项多中心实用性非劣效性分组随机对照试验(RCT)。年龄在20至55岁之间的急性腰椎间盘突出症患者可选择接受康复治疗师或初级保健医生的治疗。康复治疗师对患者进行独立评估和管理,包括开药。主要结果是六周后的残疾程度(罗兰-莫里斯残疾问卷,范围 0-24)。次要结果包括疼痛、残疾风险预后、护理满意度、医疗资源使用和等待时间。数据收集时间为基线、六周和十二周。采用混合模型回归分析比较各组结果。除主要结果的非劣效性分析外,其他分析的双侧显著性水平均为 0.05:共招募了 60 名患者(PT:32 人,FP:28 人)。经调整后,两组患者在 6 周时的残疾平均差异为 0.39,FP 组更胜一筹(95%CI:-2.03; 2.81,p = 0.753)。考虑到 5 分的最小临床重要性差异,就主要结果而言,FCP 主导的护理模式并不比常规 FP 护理差。在3个月时的残疾程度以及6周和3个月时的疼痛程度方面,组间差异无统计学意义。康复治疗师开出的药物处方明显少于全科医生(P 结论:康复治疗师开出的药物处方明显少于全科医生:这是首个评估全科医生高级实践护理模式(包括初级保健中的医疗委托行为)影响的 RCT。我们的研究结果表明,以全科医生为主导的护理模式在6周后的残疾程度方面并不逊色于常规的全科医生护理。FCP模式可能会在医疗资源使用方面带来益处。要得出更有力的结论,还需要进一步开展样本量更大的充分研究:该研究已于2022年1月20日在ClinicalTrials.gov(NCT05200533)上注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Health Services Research
BMC Health Services Research 医学-卫生保健
CiteScore
4.40
自引率
7.10%
发文量
1372
审稿时长
6 months
期刊介绍: BMC Health Services Research is an open access, peer-reviewed journal that considers articles on all aspects of health services research, including delivery of care, management of health services, assessment of healthcare needs, measurement of outcomes, allocation of healthcare resources, evaluation of different health markets and health services organizations, international comparative analysis of health systems, health economics and the impact of health policies and regulations.
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