Prevention Trial to Achieve Cardiovascular Targets

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets

Conditions
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Coronary Artery Disease, Peripheral Arterial Disease, Hyperlipidemia, Hypertension, Diabetes, Prediabetes, Obesity

Intervention / Treatment
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* Behavioral: Prevention Consult
* Behavioral: Consult & Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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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: Life expectancy less than 1-year Inability to walk

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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<br>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 Consult<br>* 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.<br>|
| Active Comparator: Consult & Behavioral Intervention<br>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. | Behavioral: Consult & Behavioral Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Non-HDL cholesterol |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipids | LDL-C, HDL, triglycerides | 6 months | 
| Metabolic risk factors | weight, BMI, HbA1C, abdominal circumference | 6 months | 
| Physical Activity | Yale Physical Activity assessment (Part 2) | 6 months | 
| Nutrition | Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions | 6 months | 
| Medication Adherence | Morisky-4 medication adherence survey | 6 months | 
| Optimal medical regimen | assessment of lipid lowering and cardiovascular medication regimen | 6 months | 
| Quality of life | Euro Qual 5D survey | 6 months | 
| Smoking cessation | Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment | 6 months | 
| Cardiovascular risk | cardiovascular risk assessment score (i.e. Framingham) | 6 months | 
| Cardiovascular events | cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years | 5 years |