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

June 26, 2023 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Auvergne-Rhône-Alpes
      • Annecy, Auvergne-Rhône-Alpes, France, 74960
        • Recruiting
        • Maison de santé pluriprofessionnelle de Cran Gévrier
        • Contact:
        • Principal Investigator:
          • Bruno Mas
      • Chambéry, Auvergne-Rhône-Alpes, France, 73000
        • Recruiting
        • Maison de santé pluriprofessionnelle des Hauts de Chambéry
        • Contact:
        • Principal Investigator:
          • Guillaume Bouchet, Dr
      • Coublevie, Auvergne-Rhône-Alpes, France, 38500
        • Recruiting
        • Maison de santé pluriprofessionnelle de Voiron-Sud
        • Contact:
        • Principal Investigator:
          • Patrick Lambert, Dr
      • Lans-en-Vercors, Auvergne-Rhône-Alpes, France, 38250
        • Recruiting
        • Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en Vercors
        • Contact:
        • Principal Investigator:
          • Alban Thoret
      • Moirans, Auvergne-Rhône-Alpes, France, 38430
        • Recruiting
        • Maison de santé pluriprofessionnelle de Moirans
        • Contact:
        • Principal Investigator:
          • Muriel Carlotti, Dr
      • Saint-Martin-d'Hères, Auvergne-Rhône-Alpes, France, 38400
        • Recruiting
        • Pôle de santé interprofessionnel de Saint-Martin d'Hères
        • Contact:
        • Principal Investigator:
          • Laura Vasselier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks
Time Frame: 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.
6 weeks after the initial consultation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the TS/S model on acute LBP patients' disability at 3 months
Time Frame: 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.
3 months after the initial consultation
Effect of the TS/S model on acute LBP patient's pain at 6 weeks and 3 months
Time Frame: 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.
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
Time Frame: 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.
6 weeks and 3 months after the initial consultation
Effect of the TS/S model on acute LBP patient's satisfaction
Time Frame: 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;
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 Frame: Initial consultation
Time (number of days and hours)
Initial consultation
Effect of the TS/S model on healthcare resources use
Time Frame: 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
Initial consultation, 6 weeks and 3 months after the initial consultation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

TIMC-IMAG

Investigators

  • Study Director: Nicolas Pinsault, PhD, University Grenoble Alps

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC21.0259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe