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Chest Pain Observation Unit Risk Reduction Trial

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
David A Katz, University of Iowa
ClinicalTrials.gov Identifier:
NCT00536224
First received: September 25, 2007
Last updated: March 3, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Chest Pain
Behavioral: Full counseling
Behavioral: Minimal counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Official Title: Brief Intervention to Promote Cardiovascular Risk Reduction in Patients Admitted to Chest Pain Observation Units

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • 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 ]

Enrollment: 140
Study Start Date: September 2007
Study Completion Date: January 2017
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Minimal counseling
Behavioral: Minimal 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.

Experimental: 1
Full counseling
Behavioral: Full counseling
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.

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.
  Eligibility

Ages Eligible for Study:   30 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00536224

Locations
United States, Iowa
University of Iowa Hospital
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
American Heart Association
Investigators
Principal Investigator: David A Katz, MD, MSc University of Iowa
  More Information

Publications:
Responsible Party: David A Katz, Associate Professor of Medicine, University of Iowa
ClinicalTrials.gov Identifier: NCT00536224     History of Changes
Other Study ID Numbers: 0750112Z
Study First Received: September 25, 2007
Last Updated: March 3, 2017

Keywords provided by University of Iowa:
Health promotion
Emergency Medical Services
Randomized controlled trial
Chest pain observation unit
Cardiovascular risk factors

Additional relevant MeSH terms:
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 28, 2017