Discovering Healthcare Innovations to Address Disparities in Stroke (DIADS)
The goal of this pragmatic study is to improve hypertension (HTN) control rate in blacks and to reduce racial disparity in HTN control. To accomplish this, the investigators propose to perform a cluster randomized controlled trial at the primary care provider (PCP) level and including 191 PCPs within KPNC East Bay Service Area with more than 45,000 patients in the HTN registry of which approximately 15,000 are black. The investigators will randomize all PCP patient panels to a three-arm trial to receiving either 1) usual care; or 2) culturally tailored diet and lifestyle coaching; or 3) an intensified BP management protocol with pharmacotherapy. The "Shake, Rattle and Roll" trial is named for: 1) "shake" the salt habit; 2) "rattle" the intensity of current BP management; and 3) design the interventions with the goal of being able to adapt and "roll" them out to community clinics outside of a managed care system. Primary research question: whether a primary prevention intervention of either diet and lifestyle coaching or an intensive pharmacotherapy protocol is more effective than usual care in improving rates of HTN control in blacks and thereby reducing disparities between black and white. Primary aim: By implementing either intervention, the investigators will reduce the disparity in hypertension control rates between blacks and whites by 4% at 1 year post-study enrollment. Hypothesis: Among blacks with HTN, a diet/lifestyle coaching intervention or an intensified BP management protocol will result in an increase in HTN control rate compared to usual care. Primary outcome: the proportion of patients with sustained BP control at 1 year post-study enrollment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Discovering Healthcare Innovations to Address Disparities in Stroke|
- Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
No Intervention: Usual Care
No Intervention: Medication enhancement
Pharmacist will optimize current Kaiser medication protocol for treatment of hypertension.
Experimental: Diet and Lifestyle Arm
Patients will receive up to 16 wellness coaching sessions focusing on DASH doest and lifestyle changes - Behavioral Intervention
Behavioral: Diet and Lifestyle
Patients will receive up to 16 phone based coaching sessions
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01892592
|United States, California|
|Kaiser Permanene Oakland Medical Center|
|Oakland, California, United States, 94611|