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

Abstract

Introduction: Low back pain (LBP) is a major health problem commonly requiring healthcare. In Sweden, there is a call from healthcare practitioners (HCPs) for the development, implementation and evaluation of a best practice primary healthcare model for LBP.

Aims: (1) To improve and understand the mechanisms underlying changes in HCP confidence, attitudes and beliefs for providing best practice coherent primary healthcare for patients with LBP; (2) to improve and understand the mechanisms underlying illness beliefs, self-care enablement, pain, disability and quality of life in patients with LBP; and (3) to evaluate a multifaceted and sustained implementation strategy and the cost-effectiveness of the BetterBack☺ model of care (MOC) for LBP from the perspective of the Swedish primary healthcare context.

Methods: This study is an effectiveness-implementation hybrid type 2 trial testing the hypothesised superiority of the BetterBack☺ MOC compared with current routine care. The trial involves simultaneous testing of MOC effects at the HCP, patient and implementation process levels. This involves a prospective cohort study investigating implementation at the HCP level and a patient-blinded, pragmatic, cluster, randomised controlled trial with longitudinal follow-up at 3, 6 and 12 months post baseline for effectiveness at the patient level. A parallel process and economic analysis from a healthcare sector perspective will also be performed. Patients will be allocated to routine care (control group) or the BetterBack☺ MOC (intervention group) according to a stepped cluster dogleg structure with two assessments in routine care. Experimental conditions will be compared and causal mediation analysis investigated. Qualitative HCP and patient experiences of the BetterBack☺ MOC will also be investigated.

Dissemination: The findings will be published in peer-reviewed journals and presented at national and international conferences. Further national dissemination and implementation in Sweden and associated national quality register data collection are potential future developments of the project.

Date and version identifier: 13 December 2017, protocol version 3.

Trial registration number: NCT03147300; Pre-results.

Keywords: effectiveness; implementation; low back pain; model of care.

Figure 1

Effectiveness-implementation hybrid type 2 trial design with chronological sequence of intervention in each cluster. BCW, Behaviour Change Wheel; BIPQ, Brief Illness Perception Questionnaire; CSM, Common Sense Model of Self-Regulation; DIBQ, Determinants of Implementation Behaviour Questionnaire; EQ-5D, EuroQoL 5-Dimension Questionnaire; HCP, healthcare practitioner; MOC, model of care; NRS LBP, Numeric Rating Scale for lower back-related pain; ODI, Oswestry Disability Index; PABS-PT, Pain Attitudes and Beliefs Scale for physical therapists; PCS, Practitioner Confidence Scale; PEI, Patient Enablement Index; TDF, Theoretical Domains Framework.

Figure 2

Municipal resident population and number of physiotherapy rehabilitation clinics and therapists in the west, central and east organisational clusters in Östergötland healthcare region.

Figure 3

Current routine care clinical pathway for LBP in Östergötland healthcare region. The primary care physiotherapy process outlined by the red square is the focus area for the implementation of the BetterBack☺ model of care for LBP. GP, general practitioner; LBP, low back pain.

Figure 4

Steps involved for healthcare practitioners in delivering the contents of the BetterBack☺ model of care. ICD-10, International Classification of Diseases-10.

Figure 5

The Behavioural Change Wheel and the Theoretical Domains Framework (TDF).

Figure 6

Causal mediation model to analyse indirect mediational effects (a^kb^k) of multiple putative determinants of implementation behaviour measured with the DIBQ directly after the healthcare practitioner education/training workshop (intention stage) or at 3 or 12 months (volition stages) for the effect of baseline PCS or PABS-PT on 3-month or 12-month follow-up measurement of PCS or PABS-PT (c´). DIBQ, Determinants of Implementation Behaviour Questionnaire; PABS-PT, Pain Attitudes and Beliefs Scale for physical therapists; PCS, Practitioner Confidence Scale.

Figure 7

1-1-1 multilevel mediation model with all variables measured at level 1, but all causal paths (direct=c_j´, indirect=a_jb_j and total effects=c_j´+a_jb_j) are allowed to vary between level 2 clusters. BIPQ, Brief Illness Perception Questionnaire; NRS, Numeric Rating Scale; ODI, Oswestry Disability Index; PEI, Patient Enablement Index.