Home-Based Program to Treat High Blood Pressure in African Americans
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

      The study will enroll African American patients with uncontrolled hypertension who are
      entering the home care program of the VNSNY. It will employ a randomized design, whereby all
      VNSNY nurses who are providing direct care to the eligible study population (an estimated 300
      nurses serving an estimated 1000 African American patients with uncontrolled hypertension)
      will be randomly assigned to a control group or one of two intervention groups upon
      identification of the first eligible hypertensive patient to whom they provide care during
      the study period. Throughout the study, each nurse will continue to administer the same
      intervention, either usual care, basic intervention, or an augmented intervention, so that
      randomization will be by nurse, rather than by patient. A nurse's initial random assignment
      to a specific group (usual care, basic treatment, or augmented treatment) will determine the
      status for all new patients allocated to that particular nurse's care for the duration of the
      study.

      The two interventions to be tested include the following: 1) a "basic" intervention
      delivering key evidence-based information to nurses, physicians, and patients while the
      patient is receiving traditional post-acute home health care; and 2) an "augmented"
      intervention transitioning patients to a Home-Based HTN Support Program that extends the
      information, monitoring, and feedback available to patients and primary care physicians for a
      12-month period beyond an index home care admission. The interventions will be assessed
      relative to usual care and to each other. The analysis will estimate the impact of the basic
      and augmented interventions on nursing practices and processes of care, patient hypertension
      management (e.g., medication adherence), BP outcomes, and overall costs. Behaviors and
      outcomes will be measured at fixed points in time. Measures will be derived from a
      combination of primary and secondary data, including patient records, patient assessment
      instruments, patient interviews, home BP monitors, urine tests, and administrative files.
      Multivariate regression analyses will be conducted to determine intervention effects on study
      outcomes, adjusting for selected nurse and patient characteristics. Nurse level
      risk-adjustment will include demographics and other measures that might influence practice or
      processes of care, such as experience and education. Patient-level risk adjustment will
      include demographics, social support, and other characteristics that might influence
      behavior, service use, BP, or other health outcomes. Estimates of treatment-control group
      differences (for both treatments) generated by these models will be tested to determine the
      extent to which observed differences at the nurse and patient levels are attributable to the
      alternative intervention strategies.
    

Intervention name(s): Health Education Program; Basic Group; Control Group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; Usual Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blood Pressure, High