跳至主要内容
临床试验/NCT00139490
NCT00139490已完成不适用

Home-Based Blood Pressure Interventions for African Americans

Visiting Nurse Service of New York0 个研究点目标入组 846 人开始时间: 2006年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
846
主要终点
Changes in systolic and diastolic Blood Pressure

研究概览

简要总结

The purpose of this study is to examine the effectiveness and cost effectiveness of two organizational interventions aimed at improving blood pressure (BP) control among a high-risk, African American home care population.

详细描述

BACKGROUND:

Home health care is a non-institutional, "diverse health care setting" that provides services to a high-risk population characterized by multiple chronic conditions and significant needs for both medical and self-care management. Home health agencies discharged approximately 7.6 million patients in 1998, of whom approximately 60 to 65% were female and 12 to 15% black (US DHHS 2000; Haupt 1998). Home health patients are clinically diverse. Individuals with conditions of the circulatory system comprise the single largest share (about 22% in 1996) (Haupt 1998), while heart failure (I-IF), diabetes, chronic obstructive pulmonary disease, and essential hypertension (HTN) are patients' most frequent primary diagnoses (Haupt & Jones 1999). Most home health patients enter care after a hospitalization and more than two-thirds are discharged to the community. Management of HTN has not been a high priority for guideline adoption or quality improvement activities in home health care (Peterson 2004), even though approximately 8% of home care patients are admitted with essential HTN as a first, second, or third diagnosis (Haupt & Jones, 1999). In the words of one clinical nurse specialist, home health nurses tend to see elevated BP readings as "a set of numbers rather than a condition to be managed," despite the fact that their patients may be at high risk of future HTN-related complications by virtue of their comorbidities and history of prior hospitalization.

Teaching patients about their conditions, promoting patient self-management, helping patients adhere to medical regimens established by their physicians, and linking them to community resources are central to the role of the home health nurse (Clemen-Stone et al. 2002). However, with the advent of a home health prospective payment system, nurses are working under heightened pressure to constrain service use and reduce time in the patient's home. This pressure, in turn, may provide a disincentive to focus on high BP management issues, particularly when HTN is a second or third diagnosis and not the primary reason for which a person has been admitted to home care. Thus home health care represents a segment of the health care system where a significant number of high-risk HTN patients are served, where HTN practice likely requires significant improvement, and where nursing personnel are uniquely positioned to mobilize their care management and patient education skills to increase the proportion of treated HTN patients who achieve adequate BP control. The underlying premise of the project is that organizational change to improve BP management and outcomes will not easily occur in home health care without new intervention models, rigorous evaluation of their impact, or efforts by opinion leaders in the clinical and research communities to disseminate information on strategies that are efficacious and cost-effective. Visiting Nurse Service of New York (VNSNY), serving over 70,000 adult patients per year, provides a prominent organizational "laboratory" for testing promising new models of care.

The study is in response to a Request for Applications released in September 2003 on "Interventions to Improve Hypertension Control Rates in African Americans."

DESIGN NARRATIVE:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •African American
  • •Have uncontrolled hypertension, defined as BP greater than 140/90 mm Hg (systolic, diastolic, or both), and 130/80 mm Hg for individuals with diabetes or kidney failure

排除标准

  • •Severe heart failure
  • •Moderate to severe cognitive impairment
  • •Overall "poor" or "guarded" prognosis
  • •Life expectancy of less than 6 months from study entry

研究组 & 干预措施

A

Experimental

The augmented intervention will consist of just-in-time nurse, patient and physician information and feedback during the post-acute period, plus transition to an ongoing Home-Based HTN Support Program within approximately 30 days after the patient's admission to home health care. The augmented intervention adds an HTN Nurse Specialist (advanced practice nurse) and a lay community health worker, who will be responsible for assuring a patient's smooth transition to the Home-Based HTN Support Program and for delivering the main components of that intervention, backed up by the project physician.

干预措施: Health Education Program (Behavioral)

B

Active Comparator

The basic information and referral intervention will deliver key "just-in-time" information to nurses, patients and patients' physicians while the patient is receiving post-acute home care services. The basic intervention relies on care provided by home health nurses during the routine home health stay.

干预措施: Basic Group (Behavioral)

C

Placebo Comparator

Usual Care group

干预措施: Control Group (Behavioral)

结局指标

主要结局

Changes in systolic and diastolic Blood Pressure

时间窗: Measured at 12 months

Documented adherence to nursing-specific practices that reflect and reinforce JNC7 guidelines

时间窗: Measured at 12 months

Change in systolic and diastolic BP

时间窗: Measured at 12 months

Proportion of patients that are below the target home BP levels (135/85 mm Hg for non-diabetic and kidney disease participants; 125/75 mm Hg for diabetic and kidney disease participants

时间窗: Measured at 12 months

次要结局

  • Cost-effectiveness of the program(Measured at 12 months)
  • Medication adherence(Measured at 12 months)
  • Health care utilization(Measured at 12 months)
  • Sodium intake(Measured at 12 months)

研究者

申办方类型
Other

相似试验