Task-sharing and Shifting Model for Acute Low Back Pain

Study Overview
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Brief Summary
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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

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Task-sharing and shifting model between family physicians and physiotherapists
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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
Interventional Model Description: Cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Task-sharing and shifting<br>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. | Other: Task-sharing and shifting model between family physicians and physiotherapists<br>* Medical consultations for acute low back pain patients are shifted from family physicians to physiotherapists.<br>|
| Active Comparator: Usual care<br>In the usual care group, patients with acute low back pain are seen by their family physician. | Other: Usual care<br>* Medical consultations for acute low back pain patients are performed by family physicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks | 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. | 6 weeks after the initial consultation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of the TS/S model on acute LBP patients' disability at 3 months | Rolland Morris Disability Questionnaire It is a 24 points scale. Scores rank form 0 to 24. Higher scores mean worse outcomes as the disability level is higher. | 3 months after the initial consultation | 
| Effect of the TS/S model on acute LBP patient's pain at 6 weeks and 3 months | Brief Pain Inventory It is a 10 points scale. Scores rank from 0 to 10. Higher scores mean worse outcomes, as the pain level is higher. | 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 | Start-Back screening tool It is a 9 points scale. Scores rank from 0 to 9. Higher scores mean worse outcomes. | 6 weeks and 3 months after the initial consultation | 
| Effect of the TS/S model on acute LBP patient's satisfaction | Medrisk questionnaire It is a 5 points scale. Scores rank from 0 to 5. Higher scores mean better outcomes; | Few minutes after the initial consultation (less than one hour) | 
| Effect of the TS/S model on acute LBP patient's wait time before the initial consultation | Time (number of days and hours) | Initial consultation | 
| Effect of the TS/S model on healthcare resources use | Initial prescription of sick leave and medications, number of family physician visits, number of physical therapy appointments, number of emergency department visits at 6 weeks and 3 months | Initial consultation, 6 weeks and 3 months after the initial consultation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Task-sharing, Task-shifting, Family physician, Physiotherapist