A five-step process for designing implementable complex interventions: A worked example using the Tailored intervention for ANxiety and DEpression Management (TANDEM) for patients with chronic obstructive pulmonary disease (COPD)

Abstract

Background Healthcare interventions shown to be effective, are commonly then found to be poorly implemented in clinical practice. It is suggested that insufficient attention is given to the implementation process at the developmental phase of intervention. This study outlines a 5 step process for considering both implementation and effectiveness issues from the outset of intervention development. We use the development of a complex intervention Treatment of anxiety and or depression in patients with chronic obstructive disease (TANDEM) to illustrate this process. Methods Intervention development built upon the Medical Research Council framework for developing complex interventions and the Person Based Approach to development of behavioural interventions. Evidence synthesis, stakeholder engagement, qualitative data collection and pre-piloting were all critical steps in intervention development. Results Contact with experts in the field ensured efficiency of design. Qualitative work suggested guiding principles for the intervention such as introducing mood in relation to breathlessness, and providing flexible tailoring to patients’ needs, whilst implementation principles focused on training selected respiratory professionals and requiring supervision to ensure standards of care. Subsequent steps of intervention development, pre-piloting and intervention refinement led to an intervention that was deemed acceptable and if successful will be ready for implementation. Conclusions By following the 5-step process recommended, both effectiveness and implementation concerns can be addressed in developing health care interventions, with the likelihood that such interventions will have a more rapid translation in to health care benefits, if shown to be effective.