Programme Theory and Logic Model
Clinical trials of complex interventions should articulate a programme
theory for how the complex intervention works, which can be summarised
in a logic model (Figure 1: The OptiBreech Care Logic Model). Refining
the programme theory is an important component of feasibility work.
Our original logic model included ‘funding for team training’ as one of
the key OptiBreech inputs. As our feasibility testing progressed, it was
evident that this was not working as intended. The OptiBreech 1 protocol
recommended that an initial team of 10, including 5 obstetricians and 5
midwives, complete the in-person physiological breech birth training
programme, and funding was set aside to back-fill staff time to attend.
However, the need for social distancing precautions during the COVID-19
pandemic and the effects on staffing levels created a context in which
this was impossible for all but two sites to achieve. To adapt to the
new contextual constraints, the training package was put online. To
supplement this, local hands-on training was organised by at each site
through mandatory training and ad hoc activities, primarily led by the
breech lead midwives.
Rather than dictate how sites should achieve the proficient team
attendance criteria, given the significant uncertainties in the current
clinical and research context, we elected instead to observe our
participant sites’ own strategies, how these varied across sites, and
how they related to our key outcomes. We then used these observations to
refine our programme theory.