Methodological insights from pre-pilot phases of two complex respiratory interventions (IMP2ART; TANDEM)

Abstract

Introduction: Complex behavioural interventions, often encounter implementation issues in real-world application. Enhancing the MRC framework for developing and evaluating complex interventions, we included a real-world pre-pilot before formal piloting of two complex interventions: IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) which is developing a whole-systems implementation strategy to improve supported asthma self-management in primary care, and Tailored intervention for ANxiety and DEpression Management in COPD (TANDEM), which uses a cognitive behavioural approach to manage anxiety and depression before attendance at pulmonary rehabilitation in COPD. Methods: Following extensive development, feasibility testing and refining, each study tested the multi-level components of their interventions with up to 4 ‘real-world sites’ to optimise design for the trial. Qualitative feedback from key stakeholders was reviewed by the development groups and integrated into the final design. Results: There were many lessons learnt. In IMP2ART we changed delivery of professional education from facilitated use of a team e-learning module to a more open facilitated team session and individual access to the module. In TANDEM, training of respiratory professionals was made less threatening by replacing role-play with actors to an individual video-recorded session. Conclusion: Real-world pre-pilots resulted in significant changes to the delivery of IMP2ART and TANDEM and should be considered before formal piloting of complex interventions. Method: IMP2ART NIHR PGfAR (RP-PG-1016-20008); TANDEM: M+NIHR HTA (13/146/02)