An interventional study of Task-sharing and shifting model between family physicians and physiotherapists and Usual care in Low Back Pain, sponsored by University Hospital, Grenoble. Status unknown at 6 sites in France. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's planned enrollment of 195 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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
In the usual care group, patients with acute low back pain are seen by their family physician.
Other: Usual care
Medical consultations for acute low back pain patients are shifted from family physicians to physiotherapists.
Medical consultations for acute low back pain patients are performed by family physicians
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.
Time frame: 6 weeks after the initial consultation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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;
Time frame: 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)
Time frame: 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
Time frame: Initial consultation, 6 weeks and 3 months after the initial consultation
Plan to share: No
Started Mar 2022 (actual). Primary completion is estimated for Dec 2023, 21 months after the start.
Of 1,187 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 21 months is above that.
Counting every sponsor, half of 1,246 studies reached it within 11 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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