Abstract
BACKGROUND: To improve the effectiveness of interventions targeting non-adherence in older adults, a systematic approach to intervention design is required. The content of complex interventions and design decisions are often poorly described in published reports which makes it difficult to explore why they are ineffective. This intervention development study reports on the design of a community pharmacy-based adherence intervention using 11 Behaviour Change Techniques (BCTs) which were identified from previous qualitative research with older patients using the Theoretical Domains Framework. METHODS: Using a group consensus approach, a five-step design process was employed. This focused on decisions regarding: (1) the overall delivery format, (2) formats for delivering each BCT; (3) methods for tailoring BCTs to individual patients; (4) intervention structure; and (5) materials to support intervention delivery. The APEASE (Affordability; Practicability; Effectiveness/cost-effectiveness; Acceptability; Side effects/safety; Equity) criteria guided the selection of BCT delivery formats. RESULTS: Formats for delivering the 11 BCTs were agreed upon, for example, a paper medicines diary was selected to deliver the BCT 'Self-monitoring of behaviour'. To help tailor the intervention, BCTs were categorised into 'Core' and 'Optional' BCTs. For example, 'Feedback on behaviour' and 'Action planning' were selected as 'Core' BCTs (delivered to all patients), whereas 'Prompts and cues' and 'Health consequences' were selected as 'Optional' BCTs. A paper-based adherence assessment tool was designed to guide intervention tailoring by mapping from identified adherence problems to BCTs. The intervention was designed for delivery over three appointments in the pharmacy including an adherence assessment at Appointment 1 and BCT delivery at Appointments 2 and 3. CONCLUSIONS: This paper details key decision-making processes involved in moving from a list of BCTs through to a complex intervention package which aims to improve older patients' medication adherence. A novel approach to tailoring the content of a complex adherence intervention using 'Core' and 'Optional' BCT categories is also presented. The intervention is now ready for testing in a feasibility study with community pharmacists and patients to refine the content. It is hoped that this detailed report of the intervention content/design process will allow others to better interpret the future findings of this work.