Abstract
BackgroundGuidelines 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.MethodsIntervention 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.ResultsContact 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.ConclusionsThe 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 registrationISRCTN ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.
Highlights
Guidelines call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change
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
The Tailored intervention for ANxiety and DEpression Management (TANDEM) trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety or depression in people living with chronic obstructive pulmonary disease
Summary
Guidelines 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 recognised that effective interventions are commonly not implemented in clinical practice. There is commonly a gap between an intervention being shown to be clinically and cost effective and its implementation into practice [7, 8] Reasons for this will be multifactorial but include organisational factors not being considered sufficiently at the outset or a design which does not lend itself to delivery as intended (fidelity) in clinical practice. This is increasingly leading to multiple research phases where an effectiveness trial is followed by development and evaluation of implementation strategies [9, 10]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
