Clinical trial NCT05200533: Task-sharing and Shifting Model for Acute Low Back Pain
Official title: Task-sharing and Shifting Model Between Family Physicians and Physiotherapists for Acute Low Back Pain Patients: a Pragmatic Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Task-sharing
Task-shifting
Family physician
Physiotherapist
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
First posted: 2022-01-20
Enrollment: 195
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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)

Primary outcomes:
measure: Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks
timeFrame: 6 weeks after the initial consultation
Secondary outcomes:
measure: Effect of the TS/S model on acute LBP patients' disability at 3 months
timeFrame: 3 months after the initial consultation
measure: Effect of the TS/S model on acute LBP patient's pain at 6 weeks and 3 months
timeFrame: 6 weeks and 3 months after the initial consultation
measure: Effect of the TS/S model on acute LBP patient's psychosocial risk factors at 6 weeks and 3 months
timeFrame: 6 weeks and 3 months after the initial consultation
measure: Effect of the TS/S model on acute LBP patient's satisfaction
timeFrame: Few minutes after the initial consultation (less than one hour)
measure: Effect of the TS/S model on acute LBP patient's wait time before the initial consultation
timeFrame: Initial consultation
measure: Effect of the TS/S model on healthcare resources use
timeFrame: Initial consultation, 6 weeks and 3 months after the initial consultation
Other outcomes:
Locations:
city: Annecy
country: France
facility: Maison de santé pluriprofessionnelle de Cran Gévrier
state: Auvergne-Rhône-Alpes
city: Chambéry
country: France
facility: Maison de santé pluriprofessionnelle des Hauts de Chambéry
state: Auvergne-Rhône-Alpes
city: Coublevie
country: France
facility: Maison de santé pluriprofessionnelle de Voiron-Sud
state: Auvergne-Rhône-Alpes
city: Lans-en-Vercors
country: France
facility: Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en Vercors
state: Auvergne-Rhône-Alpes
city: Moirans
country: France
facility: Maison de santé pluriprofessionnelle de Moirans
state: Auvergne-Rhône-Alpes
city: Saint-Martin-d'Hères
country: France
facility: Pôle de santé interprofessionnel de Saint-Martin d'Hères
state: Auvergne-Rhône-Alpes
Study officials:
affiliation: University Grenoble Alps
name: Nicolas Pinsault, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.