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

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ClinicalTrials.gov Identifier: NCT03147300
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Allan Abbott, Linkoeping University

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: Current routine practice Behavioral: Multifaceted implementation of the BetterBack Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: A cluster randomised trial with dog leg design
Masking: Single (Participant)
Masking Description: Participants are blinded to assignment to the control or intervention grouping
Primary Purpose: Health Services Research
Official Title: Implementation of a Best Practice Primary Health Care Model for Low Back Pain in Sweden (BetterBack): A Cluster Randomised Trial
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Östergötland region - Control group Behavioral: Current routine practice
Current routine practice for the primary care management of LBP

Experimental: Östergötland region - Intervention group 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.




Primary Outcome Measures :
  1. 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''

  2. 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.

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. Numeric rating scale (NRS) for lower back related pain intensity during the latest week [ Time Frame: Baseline, 3, 6 and 12 months ]
    Patient rated 11-point scale consisting of integers from 0 through 10; 0 representing ''No pain'' and 10 representing ''Worst imaginable pain''

  2. Oswestry disability index (ODI) version 2.1 [ Time Frame: Baseline, 3, 6 and 12 months ]
    Patient rating of LBP disability analysed as a 0 to100 scale variable where lower scores represent lower levels of low back pain disability.

  3. The European Quality of Life Questionnaire (EQ-5D) [ Time Frame: Baseline, 3, 6 and 12 months ]
    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.

  4. The Brief Illness Perception Questionnaire (BIPQ) [ Time Frame: Baseline, 3, 6 and 12 months ]
    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

  5. Patient Enablement Index (PEI) [ Time Frame: 3, 6 and 12 months ]
    Patient rating of enablement with a score range between 0 and 12 with a higher score intended to reflect higher patient self-care enablement

  6. Patient satisfaction [ Time Frame: 3, 6 and 12 months ]
    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)?''

  7. Patient global rating of change (PGIC) [ Time Frame: 3, 6 and 12 months ]
    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.

  8. Practitioner Confidence Scale (PCS) [ Time Frame: Baseline, directly after commencement of implementation strategy and at 3 and 12 months afterwards ]
    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

  9. Clinician rated health care process measures [ Time Frame: 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) ]
    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.

  10. Pain Attitudes and Beliefs Scale for physical therapists (PABS-PT) [ Time Frame: Baseline, directly after education and at 3 and 12 months afterwards ]
    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)


Other Outcome Measures:
  1. Determinants of implementation behavour questionnaire (DIBQ) [ Time Frame: directly after commencement of implementation strategies and at 3 and 12 months after ]
    Clinician reported determinants of BetterBack implementation designed according to the Theoretical Domains Framework



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147300


Contacts
Contact: Allan Abbott, MSc Physio, PhD +46 (0)13 282495 allan.abbott@liu.se
Contact: Birgitta Öberg, MSc Physio, PhD +46 (0)13 28 28 98 birgitta.oberg@liu.se

Locations
Sweden
Östergötland health care region Recruiting
Linköping, Sweden, 58191
Contact: Allan Abbott, Mphysio, PhD    +46 (0)13 282495    allan.abbott@liu.se   
Sponsors and Collaborators
Linkoeping University
Investigators
Principal Investigator: Allan Abbott, Msc Physio, PhD Linkoeping University
Principal Investigator: Birgitta Abbott, MSc Physio, PhD Linkoeping University
Study Chair: Paul Enthoven, MSc Physio, PhD Linkoeping University
Study Chair: Karin Schröder, MSc Physio Linkoeping University
  Study Documents (Full-Text)

Documents provided by Allan Abbott, Linkoeping University:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allan Abbott, Associate Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT03147300     History of Changes
Other Study ID Numbers: BetterBack
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allan Abbott, Linkoeping University:
Low back pain
Model of care
Primary health care
Implementation
Patient-rated outcome
Clinician-rated outcome
Cost-effectiveness

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms