Shared team approach between nurses and doctors for improved risk factor management (STANDFIRM): A cluster RCT in general practice

Background and Aim: The use of evidence-based care plans in general practice improves the control of diabetes and blood pressure, but its efficacy in stroke is unknown. We aimed to determine whether an organized program of care reduced the absolute risk of cardiovascular disease in patients with stroke or TIA when compared to usual care.

Methods: In this prospective, multicenter, randomized controlled trial, we included patients hospitalized with stroke/TIA, and excluded those living >50 km from a recruitment center, recruited to another clinical trial, or discharged to a nursing home. The intervention, clustered by general practice, comprised 1) a care plan, individualized to patient’s risk factors and reviewed by a specialist, that was used to communicate optimal management between patients and their General Practitioner; and 2) homebased nurse-led education and support about risk factor management. Outcome assessors were blinded to treatment group. A sample size of 570, allowing for 20% dropouts, was required to detect a 4.5% difference in 10-year Framingham Cardiovascular Risk Score between groups; this being the primary outcome.

Results: A total of 570 patients were recruited from four hospitals; mean age 69 years (SD 14), 65% male, 77% ischemic stroke, 19% intracerebral hemorrhage and 14% TIA. The primary outcome had <10% missing data. Conclusions: With only half the dropouts expected, STANDFIRM has sufficient power for its primary outcome measure. If effective this readily applicable program, which can be funded through Medicare Benefits, will enable General Practitioners to more effectively manage their patients with stroke or TIA.