Many resources have been directed toward improving the quality and safety of health care, but major problems persist [1]. Implementation interventions are interventions designed to change clinical practice behaviour and improve the uptake of evidence into practice. To date, implementation interventions have had limited and varied effects [2]. This may be due, in part, to a lack of explicit rationale for the intervention choice and the use of inappropriate methods to design the interventions [3–5].

The design of implementation interventions requires a systematic approach with a strong rationale for design and explicit reporting of the intervention development process [6–8]. One option is to use theory to inform the design of implementation interventions [3, 9]. The UK Medical Research Council’s (MRC) guidance for developing complex interventions informed by theory [10–13] is useful as a general approach to designing an implementation intervention, but it does not provide detailed guidance about how to achieve this.

Multiple theories and frameworks of individual and organisational behaviour change exist, and often these theories have conceptually overlapping constructs [14–16]. Only a few of these theories have been tested in robust research in healthcare settings. There is currently no systematic basis for determining which among the various theories available predicts behaviour or behaviour change most precisely [17], or which is best suited to underpin implementation research [16, 18]. Theories that have been used in previous implementation research include PRECEDE (Predisposing, Reinforcing, and Enabling Constructs in Educational Diagnosis and Evaluation), diffusion of innovations, information overload, and social marketing [5].

This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research. The TDF was developed using an expert consensus process and validation to identify psychological and organisational theory relevant to health practitioner clinical behaviour change [19]. A set of 12 domains covering the main factors influencing practitioner clinical behaviour and behaviour change were identified: knowledge; skills; social/professional role and identity; beliefs about capabilities; beliefs about consequences; motivation and goals; memory, attention and decision processes; environmental context and resources; social influences; emotion; behavioural regulation; and nature of the behaviours. Relative to previously accepted, often implicit, models for developing interventions (for example, need to raise awareness, to provide information, to educate, need for an opinion leader or champion), these 12 domains provide an extensive framework that has greater coverage of potential barriers to change, and thus implies a greater range of potential intervention components.

Although improved health care can be facilitated at different levels of the health system, one important approach is to support individual health professionals to modify their clinical behaviour in response to evidence-based guidance [15]. The focus on this level is because much of health care is delivered in the context of an encounter between a health professional and a patient, making healthcare professional clinical behaviours an important proximal determinant of the quality of care that patients receive.

Development of implementation interventions can draw on theory, evidence, and practical issues in the following ways. Theory can be used to understand the factors that might influence the clinical behaviour change being targeted, to underpin possible techniques that could be used to change clinical behaviour [19], and to clarify how such techniques might work. Evidence can inform which clinical behaviours should be changed, and which potential behaviour change techniques and modes of delivery are likely to be effective. Practical issues then determine which behaviour change techniques are feasible with available resources, and which are likely to be acceptable in the relevant setting and to the targeted health professional group.

This paper outlines a method for developing an implementation intervention, drawing on the guidance from the UK MRC framework [10–12], and building on previously published methods for theory-informed intervention development [20, 21]. We discuss how we used this method for developing an implementation intervention using the example of a recently developed intervention that we tested in the IMPLEMENT cluster randomised trial [22].

The resultant IMPLEMENT intervention was delivered via two facilitated interactive small group workshops that were a combination of didactic lectures and small group discussions and activities. We also produced a DVD to distribute to all general practitioners (GPs) in the intervention group with the primary purpose of providing the material to those who could not attend the workshops. This alternative mode of delivering the same intervention content included film footage from the workshops and electronic resources related to acute low back pain management.

Step 1. Who needs to do what, differently?

The target behaviours for the IMPLEMENT intervention arose from two recommendations from the Australian evidence-based clinical practice guideline for acute low back pain [25]. The first target behaviour was to restrict the ordering of plain film x-rays to situations in which fracture is suspected because plain film x-rays are rarely helpful in the management of acute low back pain and are potentially harmful. The second target behaviour was to advise patients with acute non-specific low back pain to remain active because this reduces pain and disability.

We chose these target behaviours because they had strong supporting evidence, were potentially modifiable at a practitioner level, and were clinical behaviours to be performed by the GP during a clinical interaction early in the course of management of acute low back pain.

Step 2. Using a theoretical framework, which barriers and enablers need to be addressed?

To develop the IMPLEMENT intervention, we used the TDF [19] to identify the barriers and enablers to the target behaviours and to guide the choice of intervention components. Barriers to, and enablers of, the two target behaviours were identified in a qualitative study consisting of focus group interviews with 42 GPs in Victoria, Australia [26]. Each focus group was led by a trained facilitator who investigated the reasons GPs gave for practising, or not, in a manner consistent with the guideline recommendations. Questions were designed to explore the domains from the TDF for each of the two behaviours. Key domains were identified that described the specific barriers and enablers at a theoretical level, which then allowed us to access relevant evidence of likely effective behaviour change techniques.

Step 3. Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers?

For the IMPLEMENT trial, our selection of behaviour change techniques was informed by a matrix that mapped behaviour change techniques to the theoretical domains, based on expert consensus about effectiveness for behaviour change [27]. We used the experience of the research team including clinicians and clinician educators, together with feedback from clinical colleagues on potential intervention approaches, to determine which behaviour change techniques and modes of delivery to select.

We chose the delivery mode of facilitated workshops because interactive education is familiar, acceptable, and feasible for GPs, and there is evidence that interventions delivered using this mode of delivery may change professional practice [28]. Also, this delivery mode could be linked to the requirements for Continuing Professional Development points for GPs in Australia. Finally, the intervention was assessed by the clinical members of the research team who checked that the proposed content was likely to be regarded by participants as relevant and helpful to their practice.

Detailed documentation of the full content of the IMPLEMENT facilitated workshops is available in the Additional file 1.

Step 4. How can behaviour change be measured and understood?

We have illustrated a four-step method for developing an intervention designed to change clinical behaviour based on a theoretical framework. We have demonstrated the use of this method in a case study of designing the IMPLEMENT intervention, an intervention designed to improve the management of low back pain in general practice [22].

Many researchers who assess barriers and enablers for implementation problem assessment do not do this within a theoretical framework and are therefore limited to pragmatic, rather than theoretically informed, solutions [37]. The use of our method when designing implementation interventions allows the use of theory and empirical research, along with the results of mixed methods research, to decide upon intervention components and to build a complex intervention. This will allow for further exploration of the associations between intervention components and intervention effects [38]. We also encourage researchers involved in developing implementation interventions to better document and report their own development process thus generating a body of knowledge about explicit methods for developing these interventions.

We have illustrated a four-step systematic method for developing an intervention designed to change clinician behaviour based on a theoretical framework. We propose a streamlined approach moving directly from identified theoretical domains relevant to the implementation problem to behaviour change techniques. This method is a conceptual aid, rather than a rigid prescription; it may be iteratively adjusted and refined to suit other contexts and settings. The process outlined here can be used by researchers and quality improvement practitioners to guide a comprehensive intervention development process.

By basing implementation interventions on a theoretical approach to behaviour change and linking this to relevant and effective behaviour change techniques, researchers can make explicit, and thus investigate, the hypothesised mechanisms of change. We have argued that using such a method can facilitate the development of theory-informed implementation interventions. Finally, appropriate reporting of the processes used to develop the interventions, and of the components of the intervention, is necessary.