Shake Rattle & Roll – Design and rationale for a pragmatic trial to improve blood pressure control among blacks with persistent hypertension

Abstract

BackgroundIn Kaiser Permanente Northern California (KPNC), members had similar access to care and a very high overall rate of hypertension control. However, blacks had poorer blood pressure (BP) control than whites. The Shake Rattle & Roll (SRR) trial aimed to improve BP control rates in blacks and to reduce disparities in hypertension control. MethodsSRR was a cluster randomized controlled trial conducted at an urban medical center. All 98 adult primary care physicians (PCP) and their panels of hypertensive black patients were randomized, stratified by panel size, to one of three arms: 1) Usual Care (n = 33 PCPs, N = 1129 patients); 2) Enhanced Monitoring arm with an emphasis on improving pharmacotherapy protocol adherence (n = 34 PCPs, N = 349 patients); or 3) Lifestyle arm with a culturally tailored diet and lifestyle coaching intervention focusing on the Dietary Approaches to Stop Hypertension eating plan (n = 31 PCPs, N = 286 patients). The intervention period was for 12-months post-enrollment. Follow-up was planned for one and three years post-intervention completion. Primary outcome measure was the proportion of participants with controlled BP, defined as <140/90 mmHg, at 12-months post-enrollment. Secondary outcome included adverse cardiovascular events. An intention-to-treat analysis was carried out as the primary analysis. ConclusionSRR was a uniquely designed trial that included components from both pragmatic and explanatory methods. The pragmatic aspects allow for a more cost-effective way to conduct a clinical trial and easier implementation of successful interventions into clinical practice. However, there were also challenges of having mixed methodology with regards to trial conduction and analysis.