Background
The gap between
what we know and
what we do, between research evidence and clinical practice, is a consistent feature of healthcare delivery [
1,
2]. Changing healthcare professional behaviour to implement evidence-based guidelines into routine practice is a major challenge within the time and resource constraints of the healthcare system. Implementing guidelines for sensitive topics, such as sexuality, can be particularly difficult with healthcare professionals’ discomfort and fear of causing offence acting as additional barriers to changing patient care [
3]. Obstacles to implementation can arise at multiple levels within the healthcare system: from the individual patient to the wider environment [
4].
Multi-level interventions are interventions targeted at several levels, for example, individual patients, groups, and organisations [
5]. Implementation interventions, to improve the update of evidence into practice, can be understood as multi-level interventions that require patient, provider, system and environmental level change [
6]. The overall goal of implementation interventions is to enhance care at a
patient level to improve patient outcomes. Implementing evidence into practice often requires intervention at the
provider level to support healthcare professionals to modify established patterns of care. Ensuring sustainability requires interventions to be integrated at a
system level and to work within healthcare infrastructures for adoption into routine care. Finally, at an
environmental level, the widespread adoption of new practices requires the development of policy frameworks that embed implementation at a national or international level.
Recent years have seen advancements in behavioural science of particular relevance to the healthcare professional behaviour change at the heart of provider level interventions [
7]. Systematic guidance and lists of behavioural techniques provide tools to develop theory-based behaviour change interventions, detail the mechanisms through which change is expected to occur and describe intervention content using shared terminology [
8,
9]. The current study explores the use of these tools and techniques to develop a multi-level implementation intervention to promote the provision of sexual counselling to cardiac patients.
Sexual counselling is an under-researched aspect of healthcare provision. Sexual dysfunction among patients with cardiovascular disease is common, and return to sexual activity after a cardiac event is challenging [
10,
11]. Sexual problems can have far-reaching and negative consequences on psychological well-being, relationship satisfaction and quality of life [
12,
13]. There is evidence that sexual counselling can reduce sexual problems and improve sexual function [
14]. The World Health Organization has rated the evidence that brief sexuality-related counselling is more effective than usual care in reducing sexual difficulties as strong [
15]. Sexual counselling for cardiac patients aims to assess existing sexual problems, provide information on concerns and support safe return to sexual activity after a cardiac event or procedure [
16]. A consensus document endorsed by the American Heart Association and European Society of Cardiology recommends routine assessment of sexual problems and sexual counselling for all individuals with cardiovascular disease [
17,
18]. Despite consensus guidelines, and evidence of patient need, discussions between patients and providers about sexual activity rarely take place in practice [
19].
Exploring the healthcare context is recommended for the effective implementation of guidelines into practice [
6]. In Ireland, the Cardiac Health and Relationship Management and Sexuality (CHARMS) baseline study surveyed nationally representative samples of patients, general practitioners and cardiac rehabilitation staff about sex and cardiovascular disease [
20]. In line with international evidence, Irish cardiac patients reported high rates of sexual problems; nearly double the rate for age-matched non-cardiac samples [
21]. Patients recognised the need for support, with the majority interested in receiving sexual education and counselling. This need was not being met; two thirds of patients reported that sex had never been addressed by their healthcare provider, and when addressed, satisfaction with the manner of provision was low [
21]. General practitioners reported rarely discussing sexual concerns with cardiac patients [
22], and cardiac rehabilitation staff reported a lack of specific assessment and counselling guidance within their service [
23].
We aimed to develop the CHARMS complex multi-level intervention to address the poor implementation of evidence-based guidelines to provide sexual counselling to cardiac patients in Ireland. The overall aims of the CHARMS intervention were to:
-
Improve sexuality-related outcomes for patients with cardiac disease (patient level)
-
Increase provision of sexual counselling by healthcare providers (provider level)
-
Develop a sustainable pathway for the delivery of sexual counselling within the Irish healthcare system (system level)
As there are very few examples of documented sexual counselling interventions and existing examples are poorly described [
24], we chose to take a systematic approach to intervention development and description. The Behaviour Change Wheel (BCW) is a framework for designing interventions developed by synthesising 19 existing behaviour change frameworks [
8]. Step-by-step guidance on the use of the BCW in the systematic design of interventions has been outlined and linked to the UK Medical Research Council (MRC) guidance for the development of complex interventions [
25,
26]. At the centre of the BCW is the Capability Opportunity Motivation-Behaviour (COM-B) model, a means to understand behaviour in context. Understanding the behaviour of health professionals in context facilitates the development of interventions to target barriers to change that behaviour. Tailoring interventions to overcome context-specific barriers has been shown to improve care delivery and patient outcomes [
27].
The COM-B model describes behaviour as an interaction between an individual’s capability, opportunity and motivation to engage in the behaviour. Capability is the individual’s ability to perform a behaviour and includes both physical capability (e.g. skills) and psychological capability (e.g. knowledge). Opportunity describes the factors that lie outside the individual that facilitate or prompt behaviour and includes both physical opportunity (e.g. affordability) and social opportunity (e.g. cultural norms). Motivation describes the brain processes that energise and direct behaviour and includes both automatic motivation (e.g. habits) and reflective motivation (e.g. cost-benefit decision making). The BCW links COM-B components to nine intervention functions (coercion, education, enablement, environmental restructuring, incentivisation, modelling, persuasion, restriction, training), through which an intervention can change behaviour, and seven broad policy categories (communication/marketing, environmental/social planning, fiscal measures, guidelines, legislation, regulation, service provision) describing the decisions authorities can make to support delivery of intervention functions [
28].
The BCW approach links intervention functions to behaviour change techniques (BCTs), the observable, replicable and irreducible active ingredients of an intervention, outlined in the BCT Taxonomy v1 (BCTTv1), a structured list of BCTs [
29]. The agreed labels and definitions included in the BCTTv1 allow intervention content to be clearly described using standard terminology [
9,
29]. Existing studies have used the BCW, the COM-B model and BCT taxonomies to develop and describe implementation interventions in healthcare settings [
26,
30,
31].
This paper describes the methods used to develop the CHARMS intervention to increase the provision of sexual counselling to cardiac rehabilitation patients in Ireland following the BCW approach. By describing the use of the BCW to implement international guidelines in practice, we hope to provide guidance for future implementation intervention designers and to reflect on the usefulness of the BCW in the development of implementation interventions. The main target of behaviour change was at the provider level, to increase the provision of sexual counselling by healthcare professionals. However, as changing provider behaviour requires patient level interaction and system level integration, the multi-level nature of the intervention was considered throughout development.
Discussion
This paper describes the methods used to systematically develop the multi-level CHARMS implementation intervention to increase uptake of sexual counselling delivery guidelines by hospital cardiac rehabilitation staff in Ireland. The paper addresses a clear evidence-practice gap in the delivery of sexual counselling and describes a transparent intervention development process informed by focus group and survey data from cardiac rehabilitation staff and patients. The paper extends behavioural science methodology by using the BCW to develop an intervention in an under-researched and sensitive area of healthcare provision, the delivery of sexual counselling during cardiac rehabilitation. Our use of a systematic approach, identification of mechanisms of action and description of intervention content using standard terminology will allow the CHARMS intervention, whether effective or not, to contribute to the cumulative science of implementation intervention development. The paper also provides a worked example and a reflection on the application of the BCW to implementation intervention development, which may be useful for other researchers.
Guidance for taking a systematic approach to designing interventions is also provided by frameworks other than the BCW. Intervention mapping, for example, outlines an alternative approach to developing theory- and evidence-based health promotion programmes [
35]. One of the strengths we identified in our use of the BCW is the simplicity and coherence of the COM-B model at the core. A systematic review of the extent of use of theory in implementation research found that only 53 of 235 studies (22.5 %) had employed theories [
36]. A traditional issue with theory, particularly when working in a multi-disciplinary team, is the difficulty in selecting the most appropriate theory from a potentially long list of options [
37]. COM-B provides a simplified framework suitable for application to behaviour in any setting.
We found some of the initial steps to define and select the target behaviour to be less fundamental to the development of our intervention. Although we have outlined all of the steps included in BCW guidance in the current study, in reality, international guidelines provided the target behaviour: the delivery of sexual counselling by healthcare professionals to people with cardiovascular disease. The target behaviour may be pre-specified in other implementation interventions designed to support uptake of guidelines into practice or be decided a priori in funding applications to support intervention development.
We identified some potential ambiguities in the use of the COM-B model to identify what needs to change to alter behaviour, as exploratory data could potentially be coded in different ways. For example, barriers identified by staff around patient lack of readiness could be coded as social opportunity if seen as a reflection of the reality of Irish social and cultural norms. However, studies with patients contradict staff perceptions, as patients report a desire for sexual issues to be raised by their healthcare professional [
32]. Accordingly, perceived lack of patient readiness may be best understood as a staff member’s personal evaluations of the situation, rather than reality, and be coded as reflective motivation within the COM-B model. Multiple perspectives are an inherent characteristic of multi-level implementation interventions, and more examples of how approaches such as the BCW can be applied across patient, provider, system and environmental levels of change would be helpful in navigating the complexities of real-world implementation.
Further guidance on the translation of BCTs into intervention content would also be helpful. Although this is covered to some extent in BCW guidance under mode of delivery in phase 3 [
28], a more explicit thorough approach to the specification of proposed intervention delivery should be encouraged. We found the TIDieR checklist [
33] to be a useful tool to help specify details of proposed intervention delivery including by who, how and where the intervention would be delivered,and recommend its use as an additional phase in the BCW approach.
The BCW includes seven broad policy categories that can be used to leverage behaviour change. In line with other published examples, we found the selection of policy level categories less well defined and practical than the other BCW steps [
26,
30]. This recurring difficulty in identifying policy categories may reflect an issue with how policy is currently represented as part of the BCW approach. The identification of policy categories is currently described as step 6 of the BCW process, between the identification of intervention functions and the identification of BCTs. In practice, we found the identification of intervention functions to flow logically to the selection of BCTs, without the identification of policy categories. For implementation interventions, the policy level may be better represented as a broader over-arching aspect of the process, more in line with the consideration of the environmental level of implementation than a discreet step in intervention development to change healthcare professional behaviour.
We used the COM-B model to understand why sexual counselling is not currently being carried out, rather than the more detailed Theoretical Domains Framework [
40] which has previously been used in the development of theory-informed implementation interventions using the BCW approach [
31]. One previous study compared the use of both COM-B and the Theoretical Domains Framework and concluded that similar associations between identified barriers, intervention functions and BCTs were found using both methods [
26]. We found that the COM-B provided a sufficient framework for developing our intervention but that at times referring to the more detailed constructs included in the Theoretical Domains Framework, which have been linked to the COM-B components, was useful in clarifying uncertainty when moving through the BCW process.
Use of the COM-B model, and linking COM-B components to intervention functions and specific BCTs, allowed us to explicitly outline the proposed mechanisms of action of the CHARMS intervention. Investigating these hypothesised mechanisms of action, and whether included BCTs are effective, requires a rigorous evaluation of the intervention. A detailed evaluation, including an economic evaluation and assessment of intervention feasibility and fidelity, is planned for the CHARMS intervention. Provider and patient level outcomes and staff capability, opportunity and motivation for providing sexual counselling in cardiac rehabilitation pre- and post-intervention will be measured. Further detail on the planned intervention evaluation is provided in the protocol for the CHARMS implementation intervention pilot study [
39].
Although the benefits of systematic intervention development are generally accepted [
41], the question as to whether using the BCW and other systematic approaches increases the effectiveness of interventions has not yet been addressed. With the recent publication of a number of examples of interventions developed using the BCW approach [
26,
30,
38], the time may now be ripe to explore the acceptability, feasibility and effectiveness of interventions developed using the BCW relative to other interventions.
The environmental level of implementation was not addressed in the current study. If, in a future randomised controlled trial, we demonstrate that the CHARMS intervention is effective, the widespread implementation of the CHARMS intervention would require further development at an environmental level. The Irish Association of Cardiac Rehabilitation (IACR) is a multi-disciplinary group supported by the Irish Heart Foundation, a national heart disease and stroke charity. The IACR aims to increase awareness and understanding of cardiac rehabilitation in Ireland, improve the standard of professional education, promote an evidence-based approach to client care and facilitate communication and support between cardiac rehabilitation multi-disciplinary professionals. If the CHARMS intervention is shown to be effective and feasible, the research team will work with the IACR to establish how best to incorporate the intervention at an environmental level into national cardiovascular rehabilitation policy and training frameworks.