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

Amber C Stuart, Jason J Sico, Catherine M Viscoli, Ashis H Tayal, Silvio E Inzucchi, Gary A Ford, Karen L Furie, Robert Cote, J David Spence, David Tanne, Walter N Kernan, Amber C Stuart, Jason J Sico, Catherine M Viscoli, Ashis H Tayal, Silvio E Inzucchi, Gary A Ford, Karen L Furie, Robert Cote, J David Spence, David Tanne, Walter N Kernan

Abstract

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.

Keywords: ischemic stroke; risk factors; secondary prevention; transient ischemic attack.

Conflict of interest statement

Competing interests: JJS reports personal fees from Acorda Therapeutics. CMV has a consulting agreement with Takeda to examine selected IRIS data. SEI reports personal fees from Merck, Janssen, Novo Nordisk, Sanofi, Intarcia, Lexicon, Poxel, Boehringer Ingelheim, Eli Lilly and AstraZeneca, and other support from Takeda outside the IRIS trial. In addition, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Abbott, Merck and Sanofi have provided continuing medical education (CME) funding to SEI employer, Yale University, for projects in which he has been involved. GAF reports personal fees from Lundbeck, Cerevast, Pfizer, Athersys, AstraZeneca, Boehringer Ingelheim and Daiichi Sankyo.

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