Team-based program to improve primary care for adults with low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Using a cluster randomized design, over 100 general practitioners in French-speaking Switzerland will be assigned to either the multilevel PRIME program or usual care, and roughly 500 patients will be followed. The intervention supports clinicians in adopting guideline-based practices, delivers patient education, and creates an interprofessional care pathway tailored to each patient's needs. Primary outcomes include cost-effectiveness, imaging prescription rates, and patient-reported back-related disability, with secondary measures of opioid prescribing, sick leave, pain, function, and clinician beliefs. As a hybrid type 1 effectiveness-implementation study, the trial will also measure implementation outcomes such as acceptability, feasibility, fidelity, and adoption among clinicians.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients consulting their participating general practitioner for a primary concern of LBP (with or without leg pain)
* Above 18 years old

Exclusion Criteria:

* If they had consulted their general practitioner for a primary concern of LBP in the past 3 months, as care was already started prior to the study.
* Unable to give consent (eg. cognitive impairment)
* Unable to access comfortably an electronic device to answer the questionnaires (smartphone, computer)
* Unable to answer questionnaires in French
* Known pregnancy
* Have had back surgery in the last 6 months
* Any specific cause of LBP (e.g. inflammatory arthritis, malignancy, infection, fracture, cauda equina syndrome).
* a major strength deficit (M3 and below) due to radiculopathy or have to be referred directly to emergency or a specialist because of that. As specific causes of LBP may be unknown at the first consultation in primary care, patients with a confirmed diagnosis of specific LBP could be excluded post-allocation by an independent doctor that is part of the Data Monitoring Committee.

Where it's running

• Geneva
  Geneva, Canton of Geneva, Switzerland Recruiting
• Vaud
  Lausanne, Canton of Vaud, Switzerland Recruiting

Study contacts

• Principal investigator: Guillaume Christe, PhD — Haute Ecole de Santé Vaud
• Study coordinator: Guillaume Christe, PhD
• Email: guillaume.christe@hesav.ch
• Phone: +41 21 556 62 67

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.