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Table 1 Aspects of our development process informed by intervention development taxonomy

From: Development of an intervention to manage benzodiazepine dependence and high-risk use in the context of escalating drug related deaths in Scotland: an application of the MRC framework

Domains

Actions (numbering relates to the taxonomy of intervention  [21] development approaches

How this was achieved

Planning

2. Establishing a group or set of groups to guide the development process, thinking about engagement of relevant stakeholders such as the public, patients, practitioners, and policy makers

Two bespoke groups were set up to take part in the intervention development process

1. Intervention development group membership of 20 including, academics working in the area of substance use, NHS substance use consultants, clinical psychologists with topic expertise, community psychiatric nurses, GP’s and a person with lived experience

2. (PWLE) Group

A group made of seven members, men and women who were currently using or had previous experience of using benzodiazepines

This group was recruited by our community researcher JD using their contacts in this population. The group was made up of seven members, men and women who were currently using or had previous experience of using street benzodiazepines and opiates

These two groups participated in the intervention development process. The separate groups were established so that members of the PWLE group were represented in the intervention development group but had their own forum where it was felt they would feel more comfortable to talk openly about their experiences and the intervention itself

3. Understand the problems or issues to be addressed

Preparatory work was undertaken to explore the issues in this area including interviews with patients currently using benzodiazepines and a survey with clinicians around benzodiazepines prescribing in Scotland. Combined with DRD statistics [3] this illustrated the issues around the importance of addressing benzodiazepine use and its increasing links to DRD in Scotland. Opiates and benzodiazepines are increasingly seen linked in DRD in Scotland and as such this group was identified as the target group for the planned intervention

5. Identify possible ways of making changes to address the problems. This involves identifying what needs to change, how to bring about this change and what might need to change at individual, interpersonal, organisational, community or societal levels

Changes in benzodiazepine prescribing in the community setting in Scotland was identified as an area which could have contributed to an increase in the use of street benzodiazepines. The reduction in GP benzodiazepine prescribing because of initiatives to reduce GP prescribing through guidance and training, was seen as a driving factor in this increase in street benzodiazepine use. With polydrug use including opiate and benzodiazepine use linked to increases in DRD there needs to be research to understand this better

Individual

• PWLE need an alternative to seeking street benzodiazepines

Interpersonal

• Understanding PWLE’s reasons for using street benzodiazepines, how could these be addressed in an intervention

Organisational

• Consideration around the prescribing of benzodiazepines in those also being prescribed ORT

• Access to psychological services for PWLE who are receiving ORT

7. Consider real-world issues about cost and delivery of any intervention at this early stage to reduce the risk of implementation failure at a later stage

The research team considered who currently provided community support to PWLE as they would be best placed and the least expensive to upskill to deliver the developed intervention. This was designed to allow the intervention to be developed within the existing care and harnessing existing expertise in this area. Community Psychiatric Nurses (CPNs) were identified as being well positioned to be the main mode of intervention delivery

Also considered was the additional cost to services of prescribing diazepam to this group, the additional nursing time required to deliver the psychosocial aspects of the intervention and the possibility of an increased workload for addiction services relating to re-engagement of patients seeking this intervention

8. Consider whether it is worthwhile continuing with the process of developing the intervention

Early discussion with the broad membership of the intervention development and PWLE groups

Designing

9. Generate ideas about solutions and components and features of an intervention

Preparatory work indicated that the intervention should include both prescribing and psychosocial components and would be delivered by existing staff within the current treatment system to manage costs associated with delivering the intervention

10. Re-visit decisions about where to intervene. This can involve consideration of the different levels at which to intervene, and the wider system in which the intervention will operate

We regularly revisited the practicalities of delivering the intervention as originally planned for example the length of consultation time and frequency of consultations and what could practically be covered during a consultation. Consideration was given to the wider context of intervention delivery as well as who would be best able to deliver the intervention successfully without the need for a new care pathway

Creating

13. Make prototypes or mock-ups of the intervention, where relevant

We developed a draft of the intervention which was disseminated to both the intervention development group and the PWLE group for comment. These comments were then used to refine and finalise the intervention

Documenting

17. Document the intervention, describing the intervention so others can use it and offer instructions on how to train practitioners delivering the intervention on how to implement the intervention

The intervention was documented using the template for intervention description and replication (TIDieR) guidelines  [25] ( REF _ REF _Ref1 REF _ REF _ REFAppendix 1. TIDieR for Benzodiazepine Intervention Development Study

Furthermore, feedback through semi-structured interviews with clinical delivery staff as well as patients enabled the identification of mediators and barriers

Planning full evaluation

18. Develop the objectives of the outcomes and process evaluation

This includes determining how outcomes and mediators of change can be measured, developing measures, specifying evaluation design, recruitment and considering feasibility of a full RCT

The starting point for the intervention development in the workshops was an outline logic model which showed existing knowledge and what was needed from the group during the development process

One aspect related to the outcomes which were deemed as important for the feasibility testing of the developed intervention. Some of these had been identified previously and this was supplemented during the development process itself

These outcomes are currently being used in the feasibility testing of the intervention and will be amended as needed for a possible full RCT in the future

Mediators of change identified in the feasibility will be assessed formally as part of a process evaluation in a full trial