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Clinical Trials/NCT00536224
NCT00536224CompletedNot Applicable

Brief Intervention to Promote Cardiovascular Risk Reduction in Patients Admitted to Chest Pain Observation Units

David A Katz1 site in 1 country140 target enrollmentStarted: September 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
140
Locations
1
Primary Endpoint
Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

1

Experimental

Full counseling

Intervention: Full counseling (Behavioral)

2

Active Comparator

Minimal counseling

Intervention: Minimal counseling (Behavioral)

Outcomes

Primary Outcomes

Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking)

Time Frame: 2- and 6-months

Self-reported cardiovascular health behaviors (diet, physical activity, and smoking cessation)

Time Frame: 2- and 6-months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
David A Katz
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

David A Katz

Associate Professor of Medicine

University of Iowa

Study Sites (1)

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