Integrating clinician support with intervention design as part of a programme testing stratified care for musculoskeletal pain in general practice

The STarT Back model of stratified care for low back pain (LBP) (stratifying care according to each patient’s risk of persistent disabling pain) has been adopted widely, following a proof-of-principle randomised trial in community physiotherapy clinics [1] and an implementation study in general practice [2]. A further programme of work, STarT MSK (Subgrouping for Targeted Treatment in MuSculosKetal conditions), has been developed to test stratified care for a broader range of patients with musculoskeletal (MSK) pain in general practice. Conducting a proof-of-principle trial in general practice is challenging but has the advantage that the intervention is simultaneously “road tested” in the target clinical setting, with elements designed in an “implementation-ready” manner, enabling rapid translation into clinical practice.

General practice is a complex environment and, currently in the UK (before and since the COVID-19 pandemic), is under unprecedented pressure. In part, this is due to a shortage of general practitioners (GPs) and an ageing population, with high levels of multi-morbidity, where management is not simply a sum of the parts [3]. Changing healthcare practice in such circumstances is challenging [4‐6]. Important considerations are clinicians’ preference for established frameworks, whether they consider the intervention meaningful and relevant [7] and perceived threats to clinical autonomy [8]. Failure to address such concerns in clinical trials that are focused on innovation can result in poor recruitment to trials, compounding poor or misleading data, and a risk that the intervention will not be adopted [9].

In clinical practice, clinical decision support systems are most effective when combined with education for the professionals using them [10] and the perceived usefulness of the interventions is a decisive factor in their acceptance by clinicians [11]. In the research domain, there is a risk of focusing exclusively on research design and delivery, with clinician education and support an afterthought. In this research programme, it was clear from the start that a thorough design process would be needed for the stratified care intervention for MSK pain to be used effectively and without disrupting the consultation, and that the simultaneous design of a fully integrated clinician support package would be required. The multi-disciplinary research team brought expertise from general practice, physiotherapy, clinical research, epidemiology, social sciences, health informatics and medical education.

The aim of this paper is to detail the steps in developing and integrating a clinician support package to support GP engagement in delivering the STarT MSK intervention. We draw together findings from other parts of the programme – which have previously been published in this journal – and outline how these findings were ‘translated’ into an educational paradigm to inform the iterative development of clinician support from the initial stages of the 6-year programme through to the stage of being ready to test within a full RCT. We argue that developing adequate clinician support is a crucial aspect of broader intervention development, which is often overlooked during broader clinical intervention development, and we provide practical recommendations that can serve as a guide for the development of future primary care interventions.

This paper has detailed the iterative development throughout the course of a large-scale programme, of clinician support to deliver a complex intervention in the context of an RCT, and as such, can be a valuable practical resource for researchers developing future primary care interventions. There is a wealth of literature on the development of theory-informed interventions that aim to change clinician behaviour, with varying results (see, for instance: [24‐27]). Much of this literature focuses on development of behaviour change interventions themselves, and on evaluating clinicians’ and patients’ uptake and engagement [28‐30]; and this research has highlighted some similar challenges to those identified here, including the practical and time issues involved in engaging clinicians, and the challenge of achieving clinician ‘buy in’. There has been a lack of focus in the literature, however, on specifically developing the clinician support to enable successful delivery of interventions in RCTs, as reported here, which we argue is a crucial element of intervention development that is often overlooked.

Additionally, whilst other studies have commonly drawn on behaviour change theory such as the TDF and COM-B models to inform clinical intervention development, only very few have combined this with adult learning theory. Porcheret et al. [31] developed an intervention to be delivered by GPs to enhance self-management support for people with osteoarthritis (OA) in primary care, using the TDF to identify relevant behaviour change domains, and adopted adult learning theory to decide on the style of delivery of the intervention. However, the focus was on how the OA intervention could best be delivered in consultations to support patients’ learning, rather than the learning of GPs. Likewise, Gallagher and Bell [32] discuss the use of adult learning as part of an occupational therapy intervention for bladder and bowel management after spinal cord injury, but again the use of adult learning is focused on the learning by the patient, rather than in supporting the learning of the clinicians themselves to deliver the intervention, as we did in the current programme. This paper is therefore novel in its focus on clinician support as a key element of intervention design.

This paper has described and demonstrated the importance of designing clinician support in an evidence based, theory informed manner, in this case combining the qualitative findings using the Theoretical Domains Framework (TDF), with adult learning principles [19, 20]. Effective clinician support enables active engagement and intervention fidelity within the trial, enabling the delivery of a robust and reliable proof-of-principle trial. We have argued that developing adequate clinician support should be viewed as an important aspect of broader intervention development, which is considered from the onset of intervention design, and not only as an add-on. We intend for the practical recommendations we have provided to serve as useful a guide for the development of future primary care interventions.