Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack –study protocol

Abstract

BackgroundPatients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of future cardiovascular events. Despite compelling evidence about the efficacy of secondary prevention, a substantial gap exists between risk factor management in real life and that recommended by international guidelines. Moreover, stroke is a leading cause of disability and morbidity which partly emerges from post-stroke complications.Methods/designWe designed a block-randomised (2:1 ratio) open pragmatic trial [NCT02156778] with blinded outcome assessment comparing STROKE-CARD to usual post-stroke-patient care. STROKE-CARD is a multifaceted post-stroke disease management program with the objective of reducing recurrent cardiovascular events and improving quality of life in ischaemic stroke and TIA-patients. It combines intensified multi-domain secondary prevention, systematic detection and treatment of post-stroke complications, and patient self-empowerment. Enrolment of 2160 patients with acute ischaemic stroke or TIA (ABCD2-Score ≥ 3) is planned at two study centres in Austria. The co-primary efficacy endpoints are (i) the composite of major recurrent cardiovascular events (nonfatal stroke, nonfatal myocardial infarction, and vascular death) occurring within 12 months after the index event and (ii) one-year health-related quality-of-life measured with the European Quality of Life-5 Dimensions (EQ-5D-3 L) questionaire. Secondary endpoints include all-cause mortality, functional outcome, and target-level achievement in risk factor management.DiscussionThis trial will provide evidence on whether the pragmatic post-stroke intervention program STROKE-CARD can help prevent cardiovascular events and improve quality-of-life within the setting of a high-quality acute stroke care system. In case of success, STROKE-CARD may be implemented in daily clinical routine and serve as a model for other disease management initiatives.Trial registrationClinicalTrials.gov: NCT02156778. (June 5, 2014, retrospectively registered).Electronic supplementary materialThe online version of this article (10.1186/s12883-018-1185-2) contains supplementary material, which is available to authorized users.

Patterns in hospital readmissions after ischaemic stroke – An observational study from the Swedish stroke register (Riksstroke)

“…Strategies for structured post-stroke checklists and intervention programs are currently being developed. 27,28 In addition, the clinical concept of frailty may be a useful tool to identify and assess high-risk individuals. Frailty is the result of cumulative decline in many physiological systems during a lifetime, leading to increased vulnerability to physiological stressors and consequently, increased risk of death and institutionalisation.…”

STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial

“…We conducted this pragmatic block-randomised controlled open-label trial with blinded outcome assessment at Innsbruck University Hospital and Hospital St. John's of God Vienna. Its design has been described previously [10] . The study was approved by the ethics committees of the two study centres and is registered with ClinicalTrials.gov, number NCT02156778.…”

“…Patients were allocated to STROKE-CARD or standard care in a 2:1 ratio by block-randomisation using prescheduled alternating blocks of 8 and 4 weeks. Allocation was based on the exact date and time of the qualifying event [10] . Standard care involved in-hospital patient counselling and education, dietary advice, smoking cessation support, printed information materials (book: “After a stroke”), and a detailed discharge-from-hospital report (including patient-tailored target levels for risk factor management) to the general practitioner and the patient.…”

“…In addition to standard care, STROKE-CARD care involved an outpatient appointment for patients and care-givers scheduled three months after the index event and lasting two to three hours [10] . This additional appointment was performed by a multidisciplinary team of stroke physicians, nurses, physiotherapists, and occupational and speech therapists.…”

“…Ordinal logistic regression was used to test whether the distribution of mRS categories differed between trial arms; the proportional odds assumption was tested with the Brant test and was met. Due to a markedly skewed distribution, the Mann Whitney U-test (rather than linear regression as initially proposed in the design paper [10] ) was used to test for a difference between trial arms in the 12-month EQ-5D-3L overall health utility score. Finally, we performed pre-specified sensitivity analyses for the CVD outcome (i) adjusting for age, sex, and type of index event, (ii) analysing patients as treated, (iii) analysing only patients that were treated per protocol, and (iv) excluding patients whose index event had been a TIA with an ABCD 2 score of 3.…”