Clinical trial NCT03147300: Implementation of a Best Practice Primary Health Care Model for Low Back Pain
Official title: Implementation of a Best Practice Primary Health Care Model for Low Back Pain in Sweden (BetterBack): A Cluster Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Model of care
Primary health care
Implementation
Patient-rated outcome
Clinician-rated outcome
Cost-effectiveness
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2017-05-10
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A cluster randomised trial with dog leg design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Numeric rating scale (NRS) for lower back related pain intensity during the latest week
timeFrame: Change between baseline and 3 months post baseline
measure: Oswestry disability index (ODI) version 2.1
timeFrame: Change between baseline and 3 months post baseline
measure: Practitioner Confidence Scale (PCS)
timeFrame: Change between baseline and 3 months post baseline
measure: Incidence of participating patients recieving specialist care
timeFrame: 12 months after baseline
Secondary outcomes:
measure: Numeric rating scale (NRS) for lower back related pain intensity during the latest week
timeFrame: Baseline, 3, 6 and 12 months
measure: Oswestry disability index (ODI) version 2.1
timeFrame: Baseline, 3, 6 and 12 months
measure: The European Quality of Life Questionnaire (EQ-5D)
timeFrame: Baseline, 3, 6 and 12 months
measure: The Brief Illness Perception Questionnaire (BIPQ)
timeFrame: Baseline, 3, 6 and 12 months
measure: Patient Enablement Index (PEI)
timeFrame: 3, 6 and 12 months
measure: Patient satisfaction
timeFrame: 3, 6 and 12 months
measure: Patient global rating of change (PGIC)
timeFrame: 3, 6 and 12 months
measure: Practitioner Confidence Scale (PCS)
timeFrame: Baseline, directly after commencement of implementation strategy and at 3 and 12 months afterwards
measure: Clinician rated health care process measures
timeFrame: 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)
measure: Pain Attitudes and Beliefs Scale for physical therapists (PABS-PT)
timeFrame: Baseline, directly after education and at 3 and 12 months afterwards
Other outcomes:
measure: Determinants of implementation behavour questionnaire (DIBQ)
timeFrame: directly after commencement of implementation strategies and at 3 and 12 months after
Locations:
city: Linköping
country: Sweden
facility: Östergötland health care region
Study officials:
affiliation: Linkoeping University
name: Allan Abbott, Msc Physio, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Linkoeping University
name: Birgitta Abbott, MSc Physio, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Linkoeping University
name: Paul Enthoven, MSc Physio, PhD
role: STUDY_CHAIR
affiliation: Linkoeping University
name: Karin Schröder, MSc Physio
role: STUDY_CHAIR
References:
citation: Schroder K, Oberg B, Enthoven P, Kongsted A, Abbott A. Confidence, attitudes, beliefs and determinants of implementation behaviours among physiotherapists towards clinical management of low back pain before and after implementation of the BetterBack model of care. BMC Health Serv Res. 2020 May 19;20(1):443. doi: 10.1186/s12913-020-05197-3.
citation: Abbott A, Schroder K, Enthoven P, Nilsen P, Oberg B. Effectiveness of implementing a best practice primary healthcare model for low back pain (BetterBack) compared with current routine care in the Swedish context: an internal pilot study informed protocol for an effectiveness-implementation hybrid type 2 trial. BMJ Open. 2018 Apr 24;8(4):e019906. doi: 10.1136/bmjopen-2017-019906.