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

NCT03147300 | Completed

• 1 other identifier: BetterBack
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low back pain; Model of care; Primary health care; Implementation; Patient-rated outcome; Clinician-rated outcome; Cost-effectiveness

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Numeric rating scale (NRS) for lower back related pain intensity during the latest week

  Baseline, 3, 6 and 12 months

• Oswestry disability index (ODI) version 2.1

  Baseline, 3, 6 and 12 months

• The European Quality of Life Questionnaire (EQ-5D)

  Baseline, 3, 6 and 12 months

• The Brief Illness Perception Questionnaire (BIPQ)

  Baseline, 3, 6 and 12 months

• Patient Enablement Index (PEI)

  3, 6 and 12 months

Other Outcomes (1)

• Determinants of implementation behavour questionnaire (DIBQ)

  directly after commencement of implementation strategies and at 3 and 12 months after

Study Arms (2)

Östergötland region - Control group

ACTIVE COMPARATOR

Behavioral: Current routine practice

Östergötland region - Intervention group

EXPERIMENTAL

Behavioral: Multifaceted implementation of the BetterBack

Interventions

Current routine practice BEHAVIORAL

Current routine practice for the primary care management of LBP

Östergötland region - Control group

Multifaceted implementation of the BetterBack 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.

Östergötland region - Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Östergötland health care region

Linköping, 58191, Sweden

Location

Related Publications (2)

• 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.

  PMID: 32430047 DERIVED

• 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.

  PMID: 29691246 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allan Abbott, Msc Physio, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

• Birgitta Abbott, MSc Physio, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

• Paul Enthoven, MSc Physio, PhD

  Linkoeping University

  STUDY CHAIR

• Karin Schröder, MSc Physio

  Linkoeping University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to assignment to the control or intervention grouping
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A cluster randomised trial with dog leg design

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 10, 2017
• Study Start: April 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)