Taking care of volunteers in a stroke trial: a new assisted-management strategy

BACKGROUND AND PURPOSE: Providing participants with evidence-based care for secondary prevention is an ethical and scientific priority for trials in stroke therapy. The optimal strategy, however, is uncertain. We report the performance of a new approach for delivering preventive care to trial participants. METHODS: Participants were enrolled in the Insulin Resistance Intervention after Stroke trial, which examined the insulin sensitiser, pioglitazone versus placebo for prevention of stroke and myocardial infarction after ischaemic stroke or transient ischaemic attack. Preventive care was the responsibility of the participants’ personal healthcare providers, but investigators monitored care and provided feedback annually. We studied achievement of 8 prevention goals at baseline and 3 annual visits, with a focus on 3 priority goals: blood pressure <140/90 mm Hg, low-density lipoprotein (LDL) cholesterol <2.59 mmol/L and antithrombotic therapy. RESULTS: The proportion of participants achieving the priority goals was highest for antithrombotic use (96–99% in each year) and similar for blood pressure (66–72% in each year) and LDL (68–70% in each year). All 3 priority goals were achieved by 47–52% of participants in any given year. However, only 22% of participants achieved all 3 goals in each year. CONCLUSIONS: A strategy of monitoring care and providing feedback was associated with high average yearly achievement of 3 priority secondary prevention goals, but the majority of trial participants did not persist in being at goal over time. TRIAL REGISTRATION NUMBER: NCT00091949.