e-Care for Heart Wellness
Condition: CVD
Study type: Interventional
Phase: Phase 3

Summary: 
      The e-Care for Heart Wellness study will look at ways to reduce a person's chances of getting
      heart disease. We are asking about 100 Group Health members whose electronic medical record
      shows they have uncontrolled high blood pressure to be in the study. Having high blood
      pressure increases your future risk of heart attacks and strokes.

      There are many things you can do to help keep your heart healthy. Examples include lowering
      blood pressure and cholesterol, eating healthier, and being more active. Our goal is to test
      whether getting care and supportive emails from a dietician helps people do things like this
      to lower their chances of having a heart attack or a stroke.

      For some people, this study will involve both research and clinical care. About half the
      people in the study will receive care related to heart disease prevention from a dietician.
      It's a standard clinical practice for dieticians to help people reduce their risk of heart
      attacks and strokes. What's different about this study is using emails from a dietician to
      help people take steps to improve their heart health.
    

Detailed description: 
      Overweight and obese adults are more likely to have hypertension and other risk factors for
      cardiovascular disease (CVD). Evidence-based medication and lifestyle strategies exist for
      reducing CVD risk, but little is known about the comparative effectiveness and
      cost-effectiveness of these strategies and how best to integrate them into routine health
      care. We have previously demonstrated that Web-based pharmacist medication management
      intervention can cost-effectively improve HTN control (e-BP: Electronic Communication and
      Home Blood Pressure Monitoring; R01 HL075263, B. Green, PI). Web-based pharmacy care did not
      lead to lifestyle behavior change or weight loss. However patients who lost small amounts of
      weight (2 kg or more) were more likely to have controlled BP (p=.008), regardless of their
      study group assignment. We propose using Health Information Technology systems (HIT) to
      identify asymptomatic patients at moderate risk for CVD and invite them to participate in a
      theory-based behavioral intervention that uses the Chronic Care Model as its planning
      foundation.

      Specific Aims Aim #1: We hypothesize that using electronic databases alone, we can identify
      asymptomatic overweight or obese patients, with uncontrolled BP, and at moderate risk for CVD
      who might benefit from a behavioral intervention.

      Aim #2: We hypothesize that a dietitian-delivered behavioral intervention, that uses a
      patient shared EMR and e-communications, can be integrated into routine healthcare and will
      result in improved control of modifiable CVD risk. To test this hypothesis we will measure:

      Primary outcomes:

        1. The proportion of patients who agree to participate and complete the intervention.

        2. The change in mean systolic and diastolic BP and weight (kg), and a weight loss of 4 kg
           or more, and the change in Framingham risk score.

      Secondary outcomes:

        1. Patient satisfaction with the intervention, its effects on health related quality of
           life (HrQOL) and the cost of delivering the intervention.

      Using this information and the results of the e-BP trial we will plan a full scale,
      multi-site (2-3 health institutions with comprehensive EMR's and different geographic and
      patient populations) multi-factorial randomized trial-to test the comparative effectiveness
      of different strategies to improve control of modifiable CVD risk.
    

Intervention name(s): Dietician electronic support
Intervention type(s): Behavioral
Intervention description(s): Dietitian-delivered behavioral intervention, that uses a patient shared EMR and e-communications, will be integrated into routine healthcare and will result in improved control of modifiable CVD risk.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: CVD; uncontrolled HTN