Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Östergötland region - Control group | Active Comparator |
| |
| Östergötland region - Intervention group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Current routine practice | Behavioral | Current routine practice for the primary care management of LBP |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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'' | Baseline, 3, 6 and 12 months |
| Oswestry disability index (ODI) version 2.1 |
| Measure | Description | Time Frame |
|---|---|---|
| Determinants of implementation behavour questionnaire (DIBQ) | Clinician reported determinants of BetterBack implementation designed according to the Theoretical Domains Framework | directly after commencement of implementation strategies and at 3 and 12 months after |
Health care practictioner sample
Inclusion Criteria:
Patient sample
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Östergötland health care region | Linköping | 58191 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32430047 | Derived | 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. | |
| 29691246 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2017 | Sep 30, 2017 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
A cluster randomised trial with dog leg design
Not provided
Not provided
Participants are blinded to assignment to the control or intervention grouping
| Multifaceted implementation of the BetterBack | Behavioral | The multifaceted intervention is composed of the following:
|
|
Patient rating of LBP disability analysed as a 0 to100 scale variable where lower scores represent lower levels of low back pain disability. |
| Baseline, 3, 6 and 12 months |
| The European Quality of Life Questionnaire (EQ-5D) | 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. | Baseline, 3, 6 and 12 months |
| The Brief Illness Perception Questionnaire (BIPQ) | 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 | Baseline, 3, 6 and 12 months |
| Patient Enablement Index (PEI) | Patient rating of enablement with a score range between 0 and 12 with a higher score intended to reflect higher patient self-care enablement | 3, 6 and 12 months |
| Patient satisfaction | 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)?'' | 3, 6 and 12 months |
| Patient global rating of change (PGIC) | 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. | 3, 6 and 12 months |
| 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 | Baseline, directly after commencement of implementation strategy and at 3 and 12 months afterwards |
| Clinician rated health care process measures | 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. | 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) |
| Pain Attitudes and Beliefs Scale for physical therapists (PABS-PT) | 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) | Baseline, directly after education and at 3 and 12 months afterwards |
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |