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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
400
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.
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.
New York University Langone Medical Center
New York, New York, United States
Reduction of Non-HDL cholesterol
Time frame: 6 months
Lipids
LDL-C, HDL, triglycerides
Time frame: 6 months
Metabolic risk factors
weight, BMI, HbA1C, abdominal circumference
Time frame: 6 months
Physical Activity
Yale Physical Activity assessment (Part 2)
Time frame: 6 months
Nutrition
Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions
Time frame: 6 months
Medication Adherence
Morisky-4 medication adherence survey
Time frame: 6 months
Optimal medical regimen
assessment of lipid lowering and cardiovascular medication regimen
Time frame: 6 months
Quality of life
Euro Qual 5D survey
Time frame: 6 months
Smoking cessation
Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment
Time frame: 6 months
Cardiovascular risk
cardiovascular risk assessment score (i.e. Framingham)
Time frame: 6 months
Cardiovascular events
cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years
Time frame: 5 years
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