Task-sharing and Shifting Model for Acute Low Back Pain (LombalgIP)
Primary Purpose
Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Task-sharing and shifting model between family physicians and physiotherapists
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Task-sharing, Task-shifting, Family physician, Physiotherapist
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)
Sites / Locations
- Maison de santé pluriprofessionnelle de Cran GévrierRecruiting
- Maison de santé pluriprofessionnelle des Hauts de ChambéryRecruiting
- Maison de santé pluriprofessionnelle de Voiron-SudRecruiting
- Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en VercorsRecruiting
- Maison de santé pluriprofessionnelle de MoiransRecruiting
- Pôle de santé interprofessionnel de Saint-Martin d'HèresRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Task-sharing and shifting
Usual care
Arm Description
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.
In the usual care group, patients with acute low back pain are seen by their family physician.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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;
Effect of the TS/S model on acute LBP patient's wait time before the initial consultation
Time (number of days and hours)
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
Full Information
NCT ID
NCT05200533
First Posted
January 6, 2022
Last Updated
June 26, 2023
Sponsor
University Hospital, Grenoble
Collaborators
TIMC-IMAG
1. Study Identification
Unique Protocol Identification Number
NCT05200533
Brief Title
Task-sharing and Shifting Model for Acute Low Back Pain
Acronym
LombalgIP
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
TIMC-IMAG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Task-sharing, Task-shifting, Family physician, Physiotherapist
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized controlled trial
Masking
None (Open Label)
Masking Description
Data analysis will be blinded.
Allocation
Randomized
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Task-sharing and shifting
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
In the usual care group, patients with acute low back pain are seen by their family physician.
Intervention Type
Other
Intervention Name(s)
Task-sharing and shifting model between family physicians and physiotherapists
Intervention Description
Medical consultations for acute low back pain patients are shifted from family physicians to physiotherapists.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Medical consultations for acute low back pain patients are performed by family physicians
Primary Outcome Measure Information:
Title
Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks
Description
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
Secondary Outcome Measure Information:
Title
Effect of the TS/S model on acute LBP patients' disability at 3 months
Description
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
Title
Effect of the TS/S model on acute LBP patient's pain at 6 weeks and 3 months
Description
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
Title
Effect of the TS/S model on acute LBP patient's psychosocial risk factors at 6 weeks and 3 months
Description
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
Title
Effect of the TS/S model on acute LBP patient's satisfaction
Description
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)
Title
Effect of the TS/S model on acute LBP patient's wait time before the initial consultation
Description
Time (number of days and hours)
Time Frame
Initial consultation
Title
Effect of the TS/S model on healthcare resources use
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amelie Kechichian, PhD student
Phone
+33 (0)698304997
Email
akechichian@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Aida Mandzo
Phone
+33(0)476766816
Email
amandzo@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Pinsault, PhD
Organizational Affiliation
University Grenoble Alps
Official's Role
Study Director
Facility Information:
Facility Name
Maison de santé pluriprofessionnelle de Cran Gévrier
City
Annecy
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
74960
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline Tuttino
Email
medicran74@gmail.com
First Name & Middle Initial & Last Name & Degree
Bruno Mas
Facility Name
Maison de santé pluriprofessionnelle des Hauts de Chambéry
City
Chambéry
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
73000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Fuentes
Email
emilie.f@recoords.fr
First Name & Middle Initial & Last Name & Degree
Guillaume Bouchet, Dr
Facility Name
Maison de santé pluriprofessionnelle de Voiron-Sud
City
Coublevie
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
38500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Pages
Email
sabine.pages@free.fr
First Name & Middle Initial & Last Name & Degree
Patrick Lambert, Dr
Facility Name
Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en Vercors
City
Lans-en-Vercors
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
38250
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laetitia Wrona
Email
assistanteencoordination@gmail.com
First Name & Middle Initial & Last Name & Degree
Alban Thoret
Facility Name
Maison de santé pluriprofessionnelle de Moirans
City
Moirans
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
38430
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Pages
Email
sabine.pages@free.fr
First Name & Middle Initial & Last Name & Degree
Muriel Carlotti, Dr
Facility Name
Pôle de santé interprofessionnel de Saint-Martin d'Hères
City
Saint-Martin-d'Hères
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
38400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime Bertolini
Email
maxime.bertolini@psip-smh.fr
First Name & Middle Initial & Last Name & Degree
Laura Vasselier
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32628696
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.
Results Reference
background
PubMed Identifier
31603709
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.
Results Reference
background
PubMed Identifier
27081203
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.
Results Reference
background
PubMed Identifier
22716771
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.
Results Reference
background
PubMed Identifier
21963002
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.
Results Reference
background
PubMed Identifier
34928239
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.
Results Reference
background
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Task-sharing and Shifting Model for Acute Low Back Pain
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