A Multilevel Intervention for Low Back Pain Management in Primary Care: An Effectiveness-implementation Hybrid Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Mean incremental cost per quality-adjusted life-year (QALY) calculated using the EQ-5D-5L questionnaire
Study Overview
Brief Summary
Low back pain is the leading cause of disability worldwide and one of the main reasons for consulting in primary care. This project aims to improve the management of people with low back pain in primary care through an innovative intervention developed in collaboration with general practitioners, physiotherapists, and occupational therapists.
The main objective is to test the effectiveness of a multilevel intervention designed to improve the care pathway for individuals with low back pain consulting their general practitioner. The intervention supports healthcare professionals in adopting practices based on current guidelines, promotes patient education, and offers an interprofessional care pathway tailored to each person's needs and profile.
The study will include over 100 general practitioners in French-speaking Switzerland, randomly assigned to either the intervention group or the control group (usual care). Around 500 patients will be followed according to their doctor's approach. Their progress will be monitored over 12 months using questionnaires and administrative data.
This project addresses an urgent need to improve the care pathway in primary care. It will rigorously assess the effectiveness of this new care approach and explore the barriers and facilitators to its integration into daily practice, taking into account the experiences of both healthcare professionals and the people concerned.
Detailed Description
Using an effectiveness-implementation hybrid type I design, this study aims to test the effectiveness of a multilevel intervention in primary care for patients with LBP and investigate the implementation processes.
The primary objectives are to test the effectiveness of a multilevel intervention in primary care for patients with low back pain (PRIME: PRImary care MultilEvel intervention for low back pain) compared with usual care in terms of: (1.1) Cost-effectiveness (system-level) (1.2) Imaging prescription rate (practitioner-level); (1.3) Self-reported back-related disability (patient-level).
Secondary objectives are:
2.1 To evaluate the effectiveness of the PRIME intervention on opioid prescription rate and sick leave days prescription by general practitioners (practitioner-level) 2.2 To evaluate the effectiveness of the PRIME intervention on pain intensity, work participation, health-related quality of life, global perceived change, Pain Self-Efficacy, Fear Avoidance Beliefs, and beliefs about LBP (patient-level) 2.3 To evaluate the effectiveness of the training on clinicians' beliefs about LBP and confidence in treating patients with LBP (practitioner-level)
As an effectiveness-implementation hybrid design type 1 study, implementation process outcomes are secondary objectives. These include: (3.1) evaluating the acceptability, appropriateness, feasibility, fidelity and adoption of the multilevel intervention among general practitioners, physiotherapists and occupational therapists; (3.2) exploring barriers and facilitators to the implementation of the multilevel intervention among healthcare practitioners; (3.3) exploring the experience of a biopsychosocial 2-day experiential workshop among trained physiotherapists; (3.4) exploring the experience and acceptability of the multilevel intervention among patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
All outcome measures will be directly recorded in Redcap by the participants (no outcome assessor).
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
PRImary care MultilEvel intervention for low back pain (PRIME)
For general practitioners in this arm, they will receive 2 x 1 hour of training, will have access to trained physiotherapists and will use a dedicated clinical pathway based on risk of chronicity.
Intervention: PRImary care MultilEvel intervention for low back pain (PRIME) (Behavioral)
Usual Care
General practitioners in this arm will continue to practice as usual.
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Mean incremental cost per quality-adjusted life-year (QALY) calculated using the EQ-5D-5L questionnaire
Time Frame: 0-12 months period after enrolment
Primary system-level outcome measures will be the mean incremental cost per quality-adjusted life-year (QALY) calculated using the EQ-5D-5L questionnaire from a healthcare payer and a societal perspective
Back-related imaging rate (%) among patients with low back pain
Time Frame: 0-6 months period after enrolment
The primary practitioner-level outcome measure will be the back-related imaging rate (%) among patients with LBP during 6 months after the primary consultation.
Self-reported back-related disability measured with the Roland Morris Disability Questionnaire
Time Frame: 6 months after enrolment
The primary patient-level outcome will be self-reported back-related disability measured with the Roland Morris Disability Questionnaire (RMDQ) six months after the initial general practitioner consultation
Secondary Outcomes
- Total number of imaging exams between groups(0-6 months period)
- Beliefs about back pain(6 weeks and 6 months after enrolment)
- Pain intensity with the Numerical Rating Scale(10 days, 6 weeks, 3 months, 6 months, 9 months, 12 months after enrolment)
- Health-related quality of life (HRQL) with the EQ-5D-5L questionnaire(3, 6, 12 months after enrolment)
- Work participation with the Work Productivity and Activity Impairment Questionnaire (WPAI)(10 days, 6 weeks, 3 months, 6 months, 9 months, 12 months after enrolment)
- Pain Self-Efficacy with the Pain Self Efficacy Questionnaire short form (PSEQ-2)(6 weeks and 6 months after enrolment)
- Fear of movement(6 weeks and 6 months after enrolment)
- Depression(6 weeks and 6 months after enrolment)
- Number of patients receiving an opioid prescription(10 days, 6 weeks, 3 months, 6 months, 9 months, 12 months after enrolment)
- Catastrophization(6 weeks and 6 months after enrolment)
- Anxiety(6 weeks and 6 months after enrolment)
- Beliefs about back pain(Baseline, directly after healthcare practitioner training (average of 3 months after baseline), 6 months after healthcare practitioner training (average of 9 months after baseline).)
- Short question about confidence to perform activities people value(10 days, 6 weeks, 3 months, 6 months, 9 months, 12 months after enrolment)
- Medication prescription(10 days, 6 weeks, 3 months, 6 months, 9 months, 12 months after enrolment)
- Confidence in treating patients with LBP(Baseline, directly after healthcare practitioner training (average of 3 months after baseline), 6 months after healthcare practitioner training (average of 9 months after baseline).)
- Short question about capacity to perform activities people value(10 days, 6 weeks, 3 months, 6 months, 9 months, 12 months after enrolment)
- Dose of opioid prescription per patient(10 days, 6 weeks, 3 months, 6 months, 9 months, 12 months after enrolment)
- Back-specific imaging rate over 12 months(0-12 months periods after enrolment)
Investigators
Guillaume Christe
Associate Professor
Haute Ecole de Santé Vaud