Task-sharing and Shifting Model for Acute Low Back Pain
LombalgIP
1 other identifier
interventional
195
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Mar 2022
Typical duration for not_applicable low-back-pain
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2022
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedJune 27, 2023
June 1, 2023
1.8 years
January 6, 2022
June 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Effect of the TS/S model on acute LBP patients' disability at 3 months
3 months after the initial consultation
Effect of the TS/S model on acute LBP patient's pain at 6 weeks and 3 months
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
6 weeks and 3 months after the initial consultation
Effect of the TS/S model on acute LBP patient's satisfaction
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
Initial consultation
- +1 more secondary outcomes
Study Arms (2)
Task-sharing and shifting
EXPERIMENTALIn 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 COMPARATORIn the usual care group, patients with acute low back pain are seen by their family physician.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- TIMC-IMAGcollaborator
Study Sites (6)
Maison de santé pluriprofessionnelle de Cran Gévrier
Annecy, Auvergne-Rhône-Alpes, 74960, France
Maison de santé pluriprofessionnelle des Hauts de Chambéry
Chambéry, Auvergne-Rhône-Alpes, 73000, France
Maison de santé pluriprofessionnelle de Voiron-Sud
Coublevie, Auvergne-Rhône-Alpes, 38500, France
Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en Vercors
Lans-en-Vercors, Auvergne-Rhône-Alpes, 38250, France
Maison de santé pluriprofessionnelle de Moirans
Moirans, Auvergne-Rhône-Alpes, 38430, France
Pôle de santé interprofessionnel de Saint-Martin d'Hères
Saint-Martin-d'Hères, Auvergne-Rhône-Alpes, 38400, France
Related Publications (7)
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.
PMID: 32628696BACKGROUNDDemont 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.
PMID: 31603709BACKGROUNDChiarotto 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.
PMID: 27081203BACKGROUNDDesmeules 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.
PMID: 22716771BACKGROUNDHill 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.
PMID: 21963002BACKGROUNDKechichian 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.
PMID: 34928239BACKGROUNDKechichian 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.
PMID: 39558330DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nicolas Pinsault, PhD
University Grenoble Alps
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Data analysis will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2022
First Posted
January 20, 2022
Study Start
March 1, 2022
Primary Completion
December 15, 2023
Study Completion
January 31, 2024
Last Updated
June 27, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share