Chest Pain Observation Unit Risk Reduction Trial
Condition: Chest Pain
MeSH terms: Chest Pain; Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a brief counseling intervention initiated
      in the chest pain observation unit has a significant impact upon the health attitudes
      (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking)
      of emergency department patients.
    

Detailed description: 
      Increasingly, emergency department patients for whom a non-ischemic etiology of acute
      coronary syndrome (ACS) symptoms cannot be identified undergo further evaluation to rule out
      myocardial ischemia and appraisal of cardiovascular risk factors (CRFs) in chest pain
      observation units (CPOUs). CPOU admission may represent a "teachable moment," but there has
      been little research on the effectiveness of brief, practical interventions for
      cardiovascular risk reduction in this population, despite the fact that the vast majority of
      these patients have at least one modifiable CRF and many do not receive regular primary care
      follow-up. The purpose of this study is to determine whether a brief counseling intervention
      initiated in the CPOU has a significant impact upon health attitudes (readiness to change)
      and cardiovascular risk-related behaviors (diet, exercise, and smoking). Based on the Health
      Belief Model (HBM), the intervention is designed to provide patients with tailored
      information on their cardiovascular risk, to negotiate goals for change, and to build
      problem-solving skills. All participants who are admitted to the CPOU for evaluation of ACS
      symptoms will be randomized to brief intervention (face-to-face counseling in the CPOU,
      coupled with telephone counseling at 4 weeks) or to minimal intervention (booklet with
      general information on CRFs) after a negative initial troponin measurement. We will conduct a
      baseline survey and follow-up telephone interviews at 2- and 6-month to assess stage of
      change and CRF-related behaviors. Linear mixed models and logistic regression (with
      generalized estimating equations) will be used to compare continuous and dichotomous
      behavioral outcomes across treatment arms, respectively. The proposed trial will evaluate the
      feasibility and effectiveness of delivering brief interventions for cardiovascular risk
      reduction in the CPOU setting, will provide insight into mechanisms of behavior change in
      these patients, and will guide the development of future case management interventions.
    

Intervention name(s): Full counseling; Minimal counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The health educator generated a computerized report for the patient that outlined his/her Framingham risk score, the goal for each cardiovascular risk factor based on national guidelines, and recommended actions for achieving each goal. Based on the Ask-Advise-Assess-Assist-Arrange follow-up (5A's) framework for behavior change, counseling for specific risk-related behaviors (diet, physical activity, and smoking) was provided by a cardiovascular rehabilitation health educator in the emergency department and during telephone follow-up (2 sessions over 6 weeks). Patients also received a general informational handout on self-management of cardiovascular risk factors (AHA Brochure "Controlling your risk factors"). A full report was also be sent to the patient's primary care physician (if any) at the conclusion of counseling.; Patients assigned to the minimal counseling intervention received brief counseling (<5 minutes) on the benefits of changing lifestyle and a handout with general information on self-management of cardiovascular risk factors.
Patients assigned to minimal intervention also received an AHA brochure ("Controlling your risk factors") with general information on management of cardiovascular risk factors. At the end of 6-month follow-up, patients received a computerized report that outlined their Framingham risk score, the goal for each cardiovascular risk factor based on national guidelines, and recommended actions for achieving each goal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Health promotion; Emergency Medical Services; Randomized controlled trial; Chest pain observation unit; Cardiovascular risk factors