Engagement beyond the research team
As expected, patients would present often at short notice
any time of day or night. PPCI activations averaged three
per 24-hour period. It was not feasible that a researcher
would be on hand to carry out the minimal eligibility
checks and perform randomisation 24/7. This was a
threat to the objective of recruiting a representative
population; overcoming it would require the full
commitment of clinical colleagues. The randomisation
process would have to be accessible, simple and quick.
One of the research nurses devised a bespoke
randomisation database permanently displayed on a
dedicated computer (sealed sequential randomisation
envelopes were also provided, to allow for power or
system failure).
Training was given to allow randomisation by any
member of the clinical team comprising nurses, doctors,
physiologists and radiographers.
HEAT-PPCI had a pragmatic design. Data was
captured by researchers from the routine care and
observations of the clinical teams. Full appreciation
and engagement from both catheter laboratory and
ward nursing teams would be crucial. The research
nurses organised education and training sessions for
staff in each clinical area. This was to encourage
understanding of the trial and to give area-specific
guidance. A series of ‘1 minute presentations’ was
devised to give a quick, bullet-point-style overview of
the main features. Large, professionally produced,
area-specific trial posters were produced to give
targeted guidance. For example, in the catheter
laboratory, posters gave advice about randomisation
and antiplatelet loading, while ward posters specified
optimal timings for blood testing; mugs and pens
displaying the trial logo were distributed; and
newsletters were circulated every couple of months to
share recruitment data, and to explain key trial and
general research concepts.