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| Name | Class |
|---|---|
| TIMC-IMAG | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Task-sharing and shifting | Experimental | 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. |
|
| Usual care | Active Comparator | In the usual care group, patients with acute low back pain are seen by their family physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Task-sharing and shifting model between family physicians and physiotherapists | Other | Medical consultations for acute low back pain patients are shifted from family physicians to physiotherapists. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelie Kechichian, PhD student | Contact | +33 (0)698304997 | akechichian@chu-grenoble.fr | |
| Aida Mandzo | Contact | +33(0)476766816 | amandzo@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Pinsault, PhD | University Grenoble Alps | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maison de santé pluriprofessionnelle de Cran Gévrier | Recruiting | Annecy | Auvergne-Rhône-Alpes | 74960 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32628696 | Background | Babatunde OO, Bishop A, Cottrell E, Jordan JL, Corp N, Humphries K, Hadley-Barrows T, Huntley AL, van der Windt DA. A systematic review and evidence synthesis of non-medical triage, self-referral and direct access services for patients with musculoskeletal pain. PLoS One. 2020 Jul 6;15(7):e0235364. doi: 10.1371/journal.pone.0235364. eCollection 2020. | |
| 31603709 |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D059825 | Physical Therapists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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Cluster randomized controlled trial
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Data analysis will be blinded.
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| Usual care | Other | Medical consultations for acute low back pain patients are performed by family physicians |
|
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 |
| Maison de santé pluriprofessionnelle des Hauts de Chambéry | Recruiting | Chambéry | Auvergne-Rhône-Alpes | 73000 | France |
|
| Maison de santé pluriprofessionnelle de Voiron-Sud | Recruiting | Coublevie | Auvergne-Rhône-Alpes | 38500 | France |
|
| Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en Vercors | Recruiting | Lans-en-Vercors | Auvergne-Rhône-Alpes | 38250 | France |
|
| Maison de santé pluriprofessionnelle de Moirans | Recruiting | Moirans | Auvergne-Rhône-Alpes | 38430 | France |
|
| Pôle de santé interprofessionnel de Saint-Martin d'Hères | Recruiting | Saint-Martin-d'Hères | Auvergne-Rhône-Alpes | 38400 | France |
|
| Demont A, Bourmaud A, Kechichian A, Desmeules F. The impact of direct access physiotherapy compared to primary care physician led usual care for patients with musculoskeletal disorders: a systematic review of the literature. Disabil Rehabil. 2021 Jun;43(12):1637-1648. doi: 10.1080/09638288.2019.1674388. Epub 2019 Oct 11. |
| 27081203 | Background | Chiarotto A, Maxwell LJ, Terwee CB, Wells GA, Tugwell P, Ostelo RW. Roland-Morris Disability Questionnaire and Oswestry Disability Index: Which Has Better Measurement Properties for Measuring Physical Functioning in Nonspecific Low Back Pain? Systematic Review and Meta-Analysis. Phys Ther. 2016 Oct;96(10):1620-1637. doi: 10.2522/ptj.20150420. Epub 2016 Apr 14. |
| 22716771 | Background | Desmeules F, Roy JS, MacDermid JC, Champagne F, Hinse O, Woodhouse LJ. Advanced practice physiotherapy in patients with musculoskeletal disorders: a systematic review. BMC Musculoskelet Disord. 2012 Jun 21;13:107. doi: 10.1186/1471-2474-13-107. |
| 21963002 | Background | Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28. |
| 34928239 | Background | Kechichian A, Lafrance S, Matifat E, Dube F, Lussier D, Benhaim P, Perreault K, Filiatrault J, Rainville P, Higgins J, Rousseau J, Masse J, Desmeules F. Multimodal Interventions Including Rehabilitation Exercise for Older Adults With Chronic Musculoskeletal Pain: A Systematic Review and Meta-analyses of Randomized Controlled Trials. J Geriatr Phys Ther. 2022 Jan-Mar 01;45(1):34-49. doi: 10.1519/JPT.0000000000000279. |
| 39558330 | Derived | Kechichian A, Desmeules F, Girard P, Terrisse H, Vermorel C, Pinsault N. Physiotherapists as first-contact practitioners for patients with low back pain in French primary care: a pragmatic cluster randomised controlled trial. BMC Health Serv Res. 2024 Nov 18;24(1):1427. doi: 10.1186/s12913-024-11814-2. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |