Practical Issues In The Design And Implementation Of Research Psychology

[Flocka Bilodeau]

Thereis little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. 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 intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood?

A complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change.

We have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process.

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.

We used a four-step approach, consisting of guiding questions to direct the choice of the most appropriate components of an implementation intervention (Table 1). The four steps represent: identifying the problem (who needs to do what, differently?); assessing the problem (using a theoretical framework, which barriers and enablers need to be addressed?); forming possible solutions (which intervention components could overcome the modifiable barriers and enhance the enablers?); and evaluating the selected intervention (how can behaviour change be measured and understood?).

We selected the target clinical behaviours to be addressed, based on documented evidence-practice gaps. We specified the target behaviours in detail by asking the following questions: What is the clinical behaviour (or series of linked behaviours) that you will try to change? Who performs the behaviour(s)? And when and where do they perform the behaviour(s)?

We chose a theoretical framework that we considered was most likely to inform the pathways of behaviour change. We used qualitative methods, underpinned by this theoretical framework, to identify the barriers and enablers to the pathways of change that were likely to influence the target clinical behaviours.

Informed by our chosen theoretical framework, and empirical evidence about effectiveness of behaviour change techniques, we identified techniques to overcome the barriers and enhance the enablers. We first established the content of the intervention (what will actually be delivered), then we identified possible modes of delivery (how each chosen technique would be delivered) [23]. We based the final selection of behaviour change techniques and mode of delivery on what we considered was locally relevant, likely to be feasible, and could be implemented as a cohesive intervention.

We determined in advance the outcome measures for behaviour change and which mediators of change could be measured to evaluate the proposed pathways of change [24]. We based the selection of outcome measures on the availability of reliable and valid measures that were feasible to use.

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.

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.

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.

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.

Table 3 outlines the constructs we planned to measure in the IMPLEMENT trial, describing outcomes measured to assess the causal pathway (mediating mechanisms of behaviour change), the practitioner outcomes and the patient outcomes.

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