Stratified Primary Care for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The SPLIT project evaluates the implementation of a stratified model of care for people with
      low back pain patients who consulted primary care.This involves evaluating the process of
      implementation as well as patient level outcomes.

      The project consists of two phases: First, a before-after study comprising two sequential but
      independent cohort studies will be conducted to compare the outcomes and cost-effectiveness
      of current practice with the SPLIT stratified model of care. Second, an implementation
      strategy will be developed based on the results of a survey regarding determinants of current
      practice, and two focus groups concerning the barriers and facilitators for the
      implementation of the SPLIT stratified model of care.
    

Detailed description: 
      A before after study consisting of two sequential but independent cohorts of LBP patients,
      separated by a 3 months interval will be conducted in 6 primary care units in Portugal. In
      both cohorts participants will be recruited during a 7 months period.

      Recruitment and data collection procedures will be identical for both cohorts. Participants
      will be eligible if they consult one of the participating General Practitioner practices (GA)
      due to non-specific Low Back Pain (LBP), with or without leg pain (The International
      Classification for Primary Care-2 diagnostic codes L03, L84, and L86), if they are aged
      between 18 and 65 years and able to read and speak the Portuguese language. They will be
      excluded if they have clinical signs of infection, tumor, osteoporosis, fracture, structural
      deformity, inflammatory disorder, radicular syndrome, or cauda equine syndrome, if they have
      severe depression or other psychiatric condition, if they are pregnant, or if they have
      undergone back surgery or conservative treatment in the prior 6 and 3 months, respectively.

      Patients will be recruited by their GP, who will briefly explain the study and obtain consent
      to pass the contact details to a research assistant (RA). The RA will inform the patients
      about the study and ask them if they are willing to participate and to be contacted for
      follow-up questionnaires (by phone), and whether they give permission for their LBP medical
      records to be reviewed. Patients who decline referral will not be eligible for the study and
      will follow the usual clinical care.

      On the initial screening with the RA, eligible LBP patients who consent to participate in the
      study will fill a questionnaire booklet containing socio-demographic and clinical questions,
      the Start Back Screening Tool, and patient reported outcomes concerning back-related
      disability (Roland Morris Disability Questionnaire), pain intensity (Numeric Pain Rating
      Scale), and health related quality of life (EuroQuol, five dimensions, 3 levels). These
      outcomes will be reassessed at 2 and 6 months following the first medical consultation. A
      Global Perceived Effect Scale (GPES) to assess patient overall perception of improvement with
      treatment will be added in the follow-up reassessments.

      In both cohorts no specific instruction will be given to GPs concerning their practice. They
      will be encouraged to assess and treat their patients as usually and make all the referrals
      they think are appropriate for their patients. At the end of each cohort the GPs medical
      records will be reviewed and data concerning the number of primary care consultations,
      prescribed medications, ordering of diagnostic tests, referrals to other professionals or
      services will be extracted.

      The primary outcome is back-related disability measured by the Roland Morris Disability
      Questionnaire (RMDQ). This questionnaire consists of 24 items related to activities of daily
      living and was developed to measure self-rated disability due to LBP. Each answer can be
      scored "0" or "1," thus leaving a range of scores from 0 to 24, with higher scores indicating
      higher disability. The RMDQ has shown good reliability, construct validity and responsiveness
      in studies with LBP patients. Secondary outcomes include pain, health related quality of life
      (HRQoL), and patients' perception of overall change of their back condition. Pain intensity
      will be measured by the Numeric Pain Rating Scale (NPRS). This is an 11-point self-report
      measure (0 to 10) with the labels "no pain" and "worst imaginable pain" on the ends, that has
      proven to be valid and reliable with patients with musculoskeletal pain. The EuroQuol, five
      dimensions, 3 levels (EQ-5D-3L) is a generic measuring instrument developed to assess HRQoL.
      The weight applied to the states is based on the Portuguese valuation study of the EQ-5D-3L.
      GPES is a transition scale designed to assess the patients' perception of overall change in
      their back condition. All patient reported measures are cross-culturally validated into
      European Portuguese Language showing adequate psychometric properties.

      Two criteria will be used to interpret the response to treatment: 1) the Minimal Clinically
      Important Difference established for the RMDQ and NPRS (reduction of ≥30% from baseline); the
      definition of persisting LBP disability (RMDQ score >7) at 2 and 6 months.

      In parallel with the data collection of the first cohort, an implementation plan will be
      developed. Determinants of practice (change) will be identified through the results of a
      survey about the GPs and Physical Therapists (PTs) attitudes, beliefs and confidence in
      managing LBP patients, and their adherence to clinical guidelines. Behavioural change
      strategies will be selected and implemented. Based on the published results of the current
      practice in primary care, and on the effectiveness of knowledge transfer strategies in
      similar studies, it is very likely that the intervention program will include different
      strategies such as patient-mediated interventions, educational meetings and key practice
      enablers (e.g. a web platform with information for patients, mentoring program, audit and
      feedback) targeted to GPs, PTs and patients.
    

Intervention name(s): Usual Care; SPLIT Stratified Model of Care
Intervention type(s): Drug; Other
Intervention description(s): Pain Medication, imaging, referrals to other health services, other health care appointments; Physiotherapy targeted treatment system of increasing complexity for each subgroup (low, medium or high) of risk of chronicity. Includes patient education, manual therapy and exercise
Other intervention name(s): Pain Medication; Physiotherapy
Intervention MeSH terms: Analgesics
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Low Back Pain; Risk-stratification; STarT Back; Patient outcomes; Cost-effectiveness;; Barriers and Facilitators