Implementation of a Best Practice Primary Health Care Model for Low Back Pain

Study Overview
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Brief Summary
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POPULATION: Low back pain (LBP) is a major health problem commonly requiring health care. In Sweden, primary care professionals require an evidenced based model of care for LBP. INTERVENTION: The multi-faceted implementation of a best practice BetterBack model of care for LBP. CONTROL: Current routine practice for LBP care before implementation of the BetterBack model of care. OUTCOME: Patient reported measures (function, activity, health), therapist reported measures (diagnosis, intervention, specialist referral, best practice self-confidence, determinants of implementation) and cost-effectiveness. AIM: To deliver best practice recommendations for LBP and study their most effective implementation through the BetterBack model of care. METHOD: A cluster randomised trial with dog leg design. The hypothesis is that the BetterBack model of care will result in significantly better patient and therapist outcomes as well as cost-effectiveness compared to current routine care.

Detailed Description
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Low back pain (LBP) is a major health and socioeconomic burden. LBP is usually a result of benign dysfunction and context that affects the patient's perception of pain and limits their activity and participation. At present there are no national clinical guidelines or best practice models of care in Sweden focused on the primary care of low back pain. Implementation of a model of LBP primary care based on international evidence-based guidelines is needed to improve care and patient outcomes in Sweden. This project aims to investigate the effectiveness of a best practice model of care (BetterBack) for the primary care management of LBP. A cluster randomised trial with dog leg design will be conducted in the Östergötland Health care region. The hypothesis is that the BetterBack model of care will result in significantly better patient and therapist reported outcomes as well as cost-effectiveness compared to current routine care. This by improved patient outcomes in terms of physical function, low back pain intensity, activity level, work and quality of life. Furthermore, improved care processes and knowledge support for physiotherapists can lead to a smaller proportion of patients requiring specialist care.

Official Title
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Implementation of a Best Practice Primary Health Care Model for Low Back Pain in Sweden (BetterBack): A Cluster Randomised Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Current routine practice
* Behavioral: Multifaceted implementation of the BetterBack


Participation Criteria
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Eligibility Criteria
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Health care practictioner sample Inclusion Criteria: Registered physiotherapists practicing in the allocated clinics and regularly working with patients with LBP Patient sample Inclusion Criteria: Males and females 18-65 years; Fluent in Swedish; Accessing public primary care due to a current episode of a first-time or recurrent debut of benign low back pain with or without radiculopathy Exclusion Criteria: Current diagnosis of malignancy, spinal fracture, infection, cauda equine syndrome, ankylosing spondylitis or systemic rheumatic disease, previous malignancy during the past 5 years; Current pregnancy or previous pregnancy up to 3 months before consideration of inclusion; Patients that fulfill criteria for multimodal/multi-professional rehabilitation for complex longstanding pain; Severe psychiatric diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A cluster randomised trial with dog leg design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Östergötland region - Control group<br> | Behavioral: Current routine practice<br>* Current routine practice for the primary care management of LBP<br>|
| Experimental: Östergötland region - Intervention group<br> | Behavioral: Multifaceted implementation of the BetterBack<br>* The multifaceted intervention is composed of the following: Forming an implementation forum including head of departments/managers of the rehabilitation units and the clinical researchers. Forming a support team comprised of experience clinicians as local supervisors and faculty researchers as knowledge facilitators. Developing the Betterback model of care through a collaboration of the implementation forum, support team and international experts. Forming and delivering a 2-day package of education and training that the support team can utilize to assist the use of the BetterBack model of care by clinicians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale (NRS) for lower back related pain intensity during the latest week | Patient rated 11-point scale consisting of integers from 0 through 10; 0 representing ''No pain'' and 10 representing ''Worst imaginable pain'' | Change between baseline and 3 months post baseline | 
| Oswestry disability index (ODI) version 2.1 | Patient rating of LBP disability analysed as a 0 to100 scale variable where lower scores represent lower levels of low back pain disability. | Change between baseline and 3 months post baseline | 
| Practitioner Confidence Scale (PCS) | A total of 4 items are reported by the practitioner and a total score is collated where 4 represents greatest self-confidence and 20 represents lowest self-confidence | Change between baseline and 3 months post baseline | 
| Incidence of participating patients recieving specialist care | Data on the number of participants accessing specialist care for LBP will be extracted from the Östergötland public health care region registry. | 12 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale (NRS) for lower back related pain intensity during the latest week | Patient rated 11-point scale consisting of integers from 0 through 10; 0 representing ''No pain'' and 10 representing ''Worst imaginable pain'' | Baseline, 3, 6 and 12 months | 
| Oswestry disability index (ODI) version 2.1 | Patient rating of LBP disability analysed as a 0 to100 scale variable where lower scores represent lower levels of low back pain disability. | Baseline, 3, 6 and 12 months | 
| The European Quality of Life Questionnaire (EQ-5D) | Patient rating of health-related quality of life and is computed into a 0 to 1.00 scale from worst to best possible health state by using UK index tariffs. | Baseline, 3, 6 and 12 months | 
| The Brief Illness Perception Questionnaire (BIPQ) | Patient rating of cognitive illness representations (consequences, outcome expectancy, personal control, treatment control, and knowledge), emotional representations (concern and emotions) as well as illness comprehensibility. An overall score 0-80 represents the degree to which the LBP is perceived as threatening or benign where a higher score reflects a more threatening view of the illness | Baseline, 3, 6 and 12 months | 
| Patient Enablement Index (PEI) | Patient rating of enablement with a score range between 0 and 12 with a higher score intended to reflect higher patient self-care enablement | 3, 6 and 12 months | 
| Patient satisfaction | Patient rating of satisfaction asking Over the course of treatment for this episode of low back pain or leg pain, how satisfied were you with the care provided by your health-care provider? Were you very satisfied (1), somewhat satisfied (2), neither satisfied nor dissatisfied (3), somewhat dissatisfied (4), or very dissatisfied (5)?'' | 3, 6 and 12 months | 
| Patient global rating of change (PGIC) | Patient rating of the degree of change in LBP related problems from the beginning of treatment to the present. This is measured with a balanced 11 point numerical scale. | 3, 6 and 12 months | 
| Practitioner Confidence Scale (PCS) | A total of 4 items are reported by the practitioner and a total score is collated where 4 represents greatest self-confidence and 20 represents lowest self-confidence | Baseline, directly after commencement of implementation strategy and at 3 and 12 months afterwards | 
| Clinician rated health care process measures | Grade of patient functional impairment and activity limitation according to the ICF brief core set for LBP is assesses by the physiotherapist where light, moderate, severe and very severe impairment/limitation is coded 0-4 respectively. A total score for baseline and an additional total score for follow-up measures at the final clinical contact (up to 3 months after baseline) is calculated from the sum of the functional impairments divided by the number of functional impairments and a similar total score is calculated for activity limitations. At the final clinical contact the therapists also report the ICD-10 diagnosis codes as well as type and number of patient treatment interventions. | Baseline and final clinical contact (Up to 3 months where the time point is variable depending upon the amount of clinical contact required for each patient) | 
| Pain Attitudes and Beliefs Scale for physical therapists (PABS-PT) | The PABS-PT consists of two factors where higher scores represent more treatment orientation regarding that factor, one measuring the biomedical treatment orientation (Score 0-60) and one regarding the biopsychosocial treatment orientation (Score 0-54) | Baseline, directly after education and at 3 and 12 months afterwards | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Model of care, Primary health care, Implementation, Patient-rated outcome, Clinician-rated outcome, Cost-effectiveness