Study design
pyrexia
HYPERGLYCAEMIA, HYPERTENSION, RECRUITMENT, INTRACEREBRAL HAEMORRHAGE
INTERACT3 was an international, multicentre, prospective, stepped wedge, cluster randomised, blinded, outcome assessed, controlled trial undertaken at hospitals located in nine LMICs (Brazil, China, India, Mexico, Nigeria, Pakistan, Peru, Sri Lanka, and Viet Nam), and one high-income country (Chile). The trial had a hybrid discovery–implementation design, in which clusters of patients were prospectively followed up to establish their outcome as their hospitals were randomly allocated to switch from control usual care to the intervention implementation at different timepoints. The experimental approach was done to mirror the natural process of rolling out a new quality improvement policy, that of implementing a goal-directed intensive care bundle protocol involving the rapid correction of any abnormal physiological variables (hypertension, hyperglycaemia, and pyrexia) and altered coagulation profile in patients with acute intracerebral haemorrhage. The trial followed the Consolidated Standards of Reporting Trials Extension reporting guideline for stepped wedge cluster randomised trials.The study was approved by the ethics committees at participating hospitals and appropriate regulatory authorities. A mixed consent process was applied, whereby a cluster guardian (an appropriate senior delegate [eg, chief executive officer]) provided consent for patients with acute intracerebral haemorrhage to receive the intervention as part of routine care. Participants (or an approved surrogate) provided written informed consent for the collection of sociodemographic, medical, and clinical information, and for them to be contacted to assess their outcome at 6 months. Two amendments were made to the original protocol dated July 12, 2017, to document additional sources of funding, extend the time for each intervention period to 4 months for sites in Asia to maximise the recruitment of patients, allow a transition time of 7–10 days before the sites entered the implementation period, for stratification variables to be incorporated into the randomisation programme, and to extend the study timelines (April 8, 2018); and additionally to expand the number of hospitals, further extend the study timelines, embed a process evaluation and economic evaluation within the trial, clarify the inclusion criteria for the diagnosis of intracerebral haemorrhage, include a form to document consent in patients who withdrew from the study, and clarify the patient recruitment targets within the study periods for the required sample size (Aug 12, 2019).