Using the Medical Research Council framework for randomised controlled trials (RCTs) of complex interventions to identify and develop strategies to promote effective professional practice

Article type
Authors
Watson M, Bond C, Grimshaw J, Johnston M, Walker A
Abstract
Background: The MRC (UK) framework (Figure) to develop RCTs of complex interventions comprises five components: theory, modelling, exploratory trial(s), definitive RCT and long-term implementation. The framework is flexible and does not need to be used sequentially. There is high volume of use of nonprescription medicines (NPMs) worldwide yet their supply is often inappropriate and under-researched. Strategies to promote the evidence based (EB) supply of these drugs are required.

Objectives: The MRC framework was used to inform a programme of research to identify and develop strategies to promote the EB supply of NPMs from community pharmacies in the UK.

Methods: Several pre-clinical and Phase I & II studies were undertaken using quantitative and qualitative methods. An observation study (II) and interviews identified barriers to the EB supply of NPMs. Secondary analysis (I) of data derived from an RCT identified variables associated with the EB supply of NPMs. Social-psychological theories (e.g. Theory of Planned Behaviour, Human Error Theory (HET)) were used to undertake detailed exploration of factors affecting the supply of NPMs from community pharmacies (pre-clinical).

Results: Sub-optimal communication and safety concerns are the main barriers to the EB supply of NPMs. Pharmacy staff are risk averse and this led to the use of HET as a framework to develop strategies to improve the supply of these drugs. Communication between staff and customers is sub-optimal. Only 1 in 4 consultations were compliant with professional pharmacy guidelines. Non-compliance was often attributed to violations i.e. intentional non-compliance with the guidelines. The secondary analyses showed that the likelihood of EB practice increased with: non-product presentations; pharmacist involvement; and increasing information exchange (communication). A Phase II study is underway to develop and deliver a communication skills training package for pharmacy support staff and will evaluate the effect of this intervention on the EB supply of NPMs. If this intervention is effective in the feasibility study it will be assessed in a definitive RCT.

Conclusion: This programme of research demonstrates the complexities associated with the EB supply of NPMs and how the MRC Framework can be used to develop strategies to promote effective professional practice.