Chest Pain Observation Unit Risk Reduction Trial

Not Applicable

Completed

• Conditions: Chest Pain
• Interventions: Behavioral: Minimal counseling; Behavioral: Full counseling

• Registration Number: NCT00536224
• Lead Sponsor: David A Katz

Brief 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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-25
• Study First Submitted QC: 2007-09-26
• Study First Posted: 2007-09-27
• Primary Completion: 2009-07
• Study Completion: 2017-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Minimal counseling	Minimal counseling
1	Full counseling	Full counseling

Primary Outcome Measures

Name	Time	Method
Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking)	2- and 6-months
Self-reported cardiovascular health behaviors (diet, physical activity, and smoking cessation)	2- and 6-months

Trial Locations

Locations (1)

University of Iowa Hospital; 🇺🇸 Iowa City, Iowa, United States