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

NCT ID: NCT03147300

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 467 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2019-03-31

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Östergötland region - Control group

Group Type: ACTIVE_COMPARATOR

Current routine practice

Intervention Type: BEHAVIORAL

Current routine practice for the primary care management of LBP

Östergötland region - Intervention group

Group Type: EXPERIMENTAL

Multifaceted implementation of the BetterBack

Intervention Type: BEHAVIORAL

The multifaceted intervention is composed of the following:

1. Forming an implementation forum including head of departments/managers of the rehabilitation units and the clinical researchers.

2. Forming a support team comprised of experience clinicians as local supervisors and faculty researchers as knowledge facilitators.

3. Developing the Betterback model of care through a collaboration of the implementation forum, support team and international experts.

4. 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.

Interventions

Current routine practice

Current routine practice for the primary care management of LBP

Intervention Type: BEHAVIORAL

Multifaceted implementation of the BetterBack

The multifaceted intervention is composed of the following:

1. Forming an implementation forum including head of departments/managers of the rehabilitation units and the clinical researchers.

2. Forming a support team comprised of experience clinicians as local supervisors and faculty researchers as knowledge facilitators.

3. Developing the Betterback model of care through a collaboration of the implementation forum, support team and international experts.

4. 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Registered physiotherapists practicing in the allocated clinics and regularly working with patients with LBP

Patient sample

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Allan Abbott

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allan Abbott, Msc Physio, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Birgitta Abbott, MSc Physio, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Paul Enthoven, MSc Physio, PhD

Role: STUDY_CHAIR

Linkoeping University

Karin Schröder, MSc Physio

Role: STUDY_CHAIR

Linkoeping University

Locations

Östergötland health care region

Linköping, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 32430047 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29691246 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BetterBack

Identifier Type: -

Identifier Source: org_study_id