LombalgIP: Task-sharing and Shifting Model for Acute Low Back Pain

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Recruiting

CT.gov ID

NCT05200533

Collaborator

TIMC-IMAG (Other)

195

Enrollment

Locations

Arms

Anticipated Duration (Months)

32.5

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: Task-sharing and shifting model between family physicians and physiotherapists Other: Usual care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

195 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster randomized controlled trialCluster randomized controlled trial

Masking:

None (Open Label)

Masking Description:

Data analysis will be blinded.

Primary Purpose:

Treatment

Official Title:

Task-sharing and Shifting Model Between Family Physicians and Physiotherapists for Acute Low Back Pain Patients: a Pragmatic Cluster Randomized Controlled Trial

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Task-sharing and shifting 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 Medical consultations for acute low back pain patients are shifted from family physicians to physiotherapists.
Active Comparator: Usual care 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 performed by family physicians

Arm

Intervention/Treatment

Experimental: Task-sharing and shifting

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

Medical consultations for acute low back pain patients are shifted from family physicians to physiotherapists.

Active Comparator: Usual care

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 performed by family physicians

Outcome Measures

Primary Outcome Measures

Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks [6 weeks after the initial consultation]
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 [3 months after the initial consultation]
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 [6 weeks and 3 months after the initial consultation]
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 [6 weeks and 3 months after the initial consultation]
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 [Few minutes after the initial consultation (less than one hour)]
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 [Initial consultation]
Time (number of days and hours)
Effect of the TS/S model on healthcare resources use [Initial consultation, 6 weeks and 3 months after the initial consultation]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maison de santé pluriprofessionnelle de Cran Gévrier	Annecy	Auvergne-Rhône-Alpes	France	74960
2	Maison de santé pluriprofessionnelle des Hauts de Chambéry	Chambéry	Auvergne-Rhône-Alpes	France	73000
3	Maison de santé pluriprofessionnelle de Voiron-Sud	Coublevie	Auvergne-Rhône-Alpes	France	38500
4	Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en Vercors	Lans-en-Vercors	Auvergne-Rhône-Alpes	France	38250
5	Maison de santé pluriprofessionnelle de Moirans	Moirans	Auvergne-Rhône-Alpes	France	38430
6	Pôle de santé interprofessionnel de Saint-Martin d'Hères	Saint-Martin-d'Hères	Auvergne-Rhône-Alpes	France	38400