Chest Pain Observation Unit Risk Reduction Trial

David A Katz

Status

Completed

Conditions

Chest Pain

Treatments

Behavioral: Minimal counseling

Behavioral: Full counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT00536224

200702770

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

30 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

At least one modifiable cardiovascular risk factor (smoking, hyperlipidemia, hypertension, diabetes mellitus, obesity)

Exclusion criteria

Patients who "rule-in" for myocardial ischemia at initial testing
Terminally ill (expected to survive less than 3 months)
Unavailable for 6-month follow-up
Cannot be contacted by telephone
Institutionalized persons (prisoners, nursing home residents)
Unable to provide informed consent (impaired mental status, unable to speak English)