Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic and at Risk of Chronic Low Back Pain in Primary Care

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: collaboration general practitioner and physiotherapist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 3. 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Trainig of GP and physiotherapist at collaborative coordinated care pathway | Procedure: collaboration general practitioner and physiotherapist<br>* training general practitioner and physiotherapist<br>|
| No Intervention: Control<br>without modification of the usual follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability at 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). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability at 12 months | Absolute change in overall ODI scale score between 0 and 12 months. Total score ranging from 0 (no functional disability) to 100 (severe functional disability). | 12 months | 
| Health-related quality of life at 3 months | Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 3 months and between 0 and 12 months | 3 months | 
| Health-related quality of life at 12 months | Absolute change of health-related quality of life by the EuroQol 5 Dimensions scale (EQ-5D) between 0 and 12 months | 12 months | 
| Evaluation of the course of care: compliance | number (%) of patients having followed the entire course of care | 12 months | 
| Evaluation of the course of care: number of consultations | total number of consultations with GPs and physiotherapists (PTs) | 12 months | 
| Evaluation of the course of care: medical imaging | total number of medical imaging related to low back during the follow up | 12 months | 
| Evaluation of the course of care: total cost | total cost (in euros €) of healthcare pathway in the two groups | 12 months | 
| Evaluation of effective collaborative practices | qualitative analysis of GP/PT collaboration using semi-structured interviews with professionals | 12 months |