Prevention Trial to Achieve Cardiovascular Targets (IMPACT)

• Lipids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  LCL-C, HDL triglycerides
• Metabolic risk factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  weight, BMI, HbA1C, abdominal circumference
• Physical Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Yale Physical Activity assessment (Part 2)
• Nutrition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions
• Medication Adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Morisky-4 medication adherence survey
• Optimal medical regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  assessment of lipid lowering and cardiovascular medication regimen
• Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Euro Qual 5D survey
• Smoking cessation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment
• Cardiovascular risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  cardiovascular risk assessment score (i.e. Framingham)
• Cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years

The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets) is to determine the best management strategy for patients undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will enroll 400 patients post-cardiovascular intervention. The study will compare different cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult, and (3) cardiovascular prevention consult with a behavioral intervention program over a 6-month period. The trial hypothesis is that for patients undergoing a cardiovascular intervention, a prevention consult and behavioral intervention is superior to usual care in reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary endpoints include other lipid values, metabolic risk, smoking cessation, physical activity, nutritional status, medication adherence and quality of life. IMPACT is funded by a grant from the Rainer Arnhold Foundation and is scheduled to begin enrollment in the June of 2012.

SPECIFIC AIMS

Primary aim:

The primary aim is that a targeted Cardiovascular Prevention consult will reduce non-HDL cholesterol compared to usual care at 6 months post-intervention.

Secondary aim:

The secondary aim is that a targeted Cardiovascular Prevention consult plus a behavioral intervention will reduce non-HDL cholesterol compared to usual care at 6 months post-intervention.

• Coronary Artery Disease
• Peripheral Arterial Disease
• Hyperlipidemia
• Hypertension
• Diabetes Mellitus/Prediabetes
• Obesity

• Behavioral: Prevention Consult
  In addition to usual care, patients will receive a prevention consult by a prevention fellow and attending following their intervention. The consult will include guideline based medical recommendations for optimization of the patient's medical regimen targeting dyslipidemia, hypertension and diabetes. In addition, each patient will be educated on the cardiovascular disease process and given detailed lifestyle recommendations on physical activity, improved nutrition, smoking cessation and medication adherence.
• Behavioral: Prevention Consults and Behavioral Intervention
  In addition to usual care and prevention consult (as detailed above), patients will receive a full motivational intervention program by a trained motivational coach and text messages over 6 months.

• No Intervention: Usual Care
  Usual care includes physician assistant and/or nurse based medical and lifestyle recommendations in consultation with cardiac catheterization attending or patient's clinical cardiologist to potentially improve the patient's medical and lifestyle regimen. Relevant educational material is routinely distributed to patients.
• Active Comparator: Prevention Consult
  Intervention: Behavioral: Prevention Consult
• Active Comparator: Prevention Consult and Behavioral Intervention
  Intervention: Behavioral: Prevention Consults and Behavioral Intervention

Inclusion Criteria:

• at least 21 years of age or older
• Subjects scheduled to undergo a percutaneous coronary or peripheral vascular intervention
• Patients must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Subjects with a Non-HDL value of less than 100 mg/dl
• Life expectancy less than 1-year
• Inability to walk