Jackson George L, Weinberger Morris, Kirshner Miriam A, Stechuchak Karen M, Melnyk Stephanie D, Bosworth Hayden B, Coffman Cynthia J, Neelon Brian, Van Houtven Courtney, Gentry Pamela W, Morris Isis J, Rose Cynthia M, Taylor Jennifer P, May Carrie L, Han Byungjoo, Wainwright Christi, Alkon Aviel, Powell Lesa, Edelman David
Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Medicine, Division of General Internal Medicine, Duke University, Durham, NC 27710, USA.
Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA; Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.
Contemp Clin Trials. 2016 Sep;50:5-15. doi: 10.1016/j.cct.2016.07.009. Epub 2016 Jul 12.
Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.
尽管有有效的治疗方法，但只有一半的高血压患者能实现血压的充分控制。本文描述了一项双臂、为期18个月的随机临床试验的方案和基线受试者特征，该试验针对药物治疗后收缩压（SBP）未得到控制（非糖尿病患者≥140mmHg或糖尿病患者≥130mmHg）的高血压患者进行滴定式疾病管理（TDM）。该试验在与一家退伍军人事务医疗中心相关的四个诊所地点的患者中进行。干预组采用TDM策略，即根据患者在基线、6个月和12个月时的高血压控制情况来确定疾病管理的资源强度。强度水平包括：低强度策略，利用执业护士每两个月为SBP得到控制的患者提供非针对性的行为支持电话；中等强度策略，利用注册护士每月提供针对性的行为支持电话并进行家庭血压监测；高强度策略，利用药剂师每月提供针对性的行为支持电话、家庭血压监测以及药剂师指导的药物管理。对照组患者无论血压控制情况如何，均接受低强度策略。主要结局指标是SBP。共有385名随机分组的退伍军人（192名干预组；193名对照组），他们大多是年龄较大（平均年龄63.5岁）的男性（92.5%）。61.8%为非裔美国人，所有受试者的平均基线SBP为143.6mmHg。该试验将确定与低强度管理策略相比，通过将资源强度与患者血压控制相匹配来进行滴定的疾病管理计划是否能带来更好的结局。
