Implementation of a Best Practice Primary Health Care Model for Low Back Pain in Sweden (BetterBack): A Cluster Randomised Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 467
- Locations
- 1
- Primary Endpoint
- Numeric rating scale (NRS) for lower back related pain intensity during the latest week
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Masking Description
Participants are blinded to assignment to the control or intervention grouping
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Östergötland region - Control group
Intervention: Current routine practice (Behavioral)
Östergötland region - Intervention group
Intervention: Multifaceted implementation of the BetterBack (Behavioral)
Outcomes
Primary Outcomes
Numeric rating scale (NRS) for lower back related pain intensity during the latest week
Time Frame: Change between baseline and 3 months post baseline
Patient rated 11-point scale consisting of integers from 0 through 10; 0 representing ''No pain'' and 10 representing ''Worst imaginable pain''
Oswestry disability index (ODI) version 2.1
Time Frame: Change between baseline and 3 months post baseline
Patient rating of LBP disability analysed as a 0 to100 scale variable where lower scores represent lower levels of low back pain disability.
Incidence of participating patients recieving specialist care
Time Frame: 12 months after baseline
Data on the number of participants accessing specialist care for LBP will be extracted from the Östergötland public health care region registry.
Practitioner Confidence Scale (PCS)
Time Frame: Change between baseline and 3 months post baseline
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
Secondary Outcomes
- Pain Attitudes and Beliefs Scale for physical therapists (PABS-PT)(Baseline, directly after education and at 3 and 12 months afterwards)
- Practitioner Confidence Scale (PCS)(Baseline, directly after commencement of implementation strategy and at 3 and 12 months afterwards)
- Oswestry disability index (ODI) version 2.1(Baseline, 3, 6 and 12 months)
- Patient Enablement Index (PEI)(3, 6 and 12 months)
- Patient global rating of change (PGIC)(3, 6 and 12 months)
- Numeric rating scale (NRS) for lower back related pain intensity during the latest week(Baseline, 3, 6 and 12 months)
- The European Quality of Life Questionnaire (EQ-5D)(Baseline, 3, 6 and 12 months)
- Patient satisfaction(3, 6 and 12 months)
- The Brief Illness Perception Questionnaire (BIPQ)(Baseline, 3, 6 and 12 months)
- Clinician rated health care process measures(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))
Investigators
Allan Abbott
Associate Professor
Linkoeping University