Implementation of a Best Practice Primary Health Care Model for Low Back Pain (BetterBack)
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|ClinicalTrials.gov Identifier: NCT03147300|
Recruitment Status : Active, not recruiting
First Posted : May 10, 2017
Last Update Posted : October 18, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||A cluster randomised trial with dog leg design|
|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|
|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:
- 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.
- 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
- 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.
- 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''
- 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.
- 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.
- 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
- 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
- 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)?''
- 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.
- 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
- 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.
- 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)
- 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
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
|Östergötland health care region|
|Linköping, Sweden, 58191|
|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|