Trials | |
Developing a complex intervention whilst considering implementation: the TANDEM (Tailored intervention for ANxiety and DEpression Management) intervention for patients with chronic obstructive pulmonary disease (COPD) | |
Hilary Pinnock1  Ratna Sohanpal2  Moira Kelly2  Liz Steed2  Stephanie Taylor2  Karen Heslop-Marshall3  Sarah Saqi-Waseem4  | |
[1] Allergy and Respiratory Research Group, Usher Institute of Population Health Sciences and Informatics;Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London;Newcastle upon Tyne NHS Hospitals Foundation Trust, Chest Clinic, New Victoria Wing RVI Hospital;University College London Hospitals NHS Foundation Trust; | |
关键词: Depression; Anxiety; Cognitive behavioural therapy (CBT); Self-management; Chronic obstructive pulmonary disease (COPD); Implementation; | |
DOI : 10.1186/s13063-021-05203-x | |
来源: DOAJ |
【 摘 要 】
Abstract Background Guidelines now call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change. This was the primary aim of this study but we also recognised that effective interventions are commonly not implemented in clinical practice. It is suggested that insufficient attention is given to the implementation process at the development phase of interventions. This study outlines the 5 step iterative process we adopted for considering both implementation and effectiveness issues from the outset of intervention development. We use the development of a complex intervention Tailored intervention for ANxiety and DEpression Management (TANDEM) in patients with chronic obstructive pulmonary disease to illustrate this process. Methods Intervention development built upon the Medical Research Council framework for developing complex interventions and the person-based approach for development of behavioural interventions. Building an expert team, specifying theory, qualitative data collection and pre-piloting were all critical steps in our intervention development and are described here. Results Contact with experts in the field, and explicitly building on previous work, 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 The TANDEM study was developed efficiently by building on previous work and considering implementation issues from the outset, with the aim that if shown to be effective it will have more rapid translation in to the health care system with accelerated patient benefits. Trial registration ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.
【 授权许可】
Unknown