Chest Pain Observation Unit Risk Reduction Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Iowa.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Heart Association
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00536224
First received: September 25, 2007
Last updated: March 12, 2009
Last verified: March 2009
  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 Phase
Chest Pain
Behavioral: Enhanced counseling
Behavioral: Minimal counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
  • Self-reported cardiovascular health behaviors (diet, physical activity, and smoking cessation) [ Time Frame: 2- and 6-months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 Behavioral: Minimal counseling
Patients assigned to minimal intervention will receive an AHA brochure ("Controlling your risk factors") with general information on management of cardiovascular risk factors. These patients will be mailed a personalized cardiovascular risk assessment report (based on baseline questionnaire and laboratory data) at the end of 6-month follow-up.
Experimental: 1 Behavioral: Enhanced counseling
The health educator will generate a computerized report for the patient that outlines his/her cardiovascular risk factors, Framingham risk score, the goal for each risk factor based on national guidelines, and recommended actions for achieving each goal. Based on the 5A's framework for behavior change, counseling for specific risk-related behaviors (diet, physical activity, and smoking) will be provided by a cardiovascular rehabilitation health educator in the emergency department and during telephone follow-up (2 sessions over 6 weeks). A full report will 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 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. Both adjusted and unadjusted multivariable analyses will be performed to determine the intervention effect (using an intention-to-treat approach). We will also use mediation analysis to evaluate the extent to which the intervention is mediated by HBM constructs (e.g., perceived susceptibility to cardiovascular adverse events, perceived benefit of risk reduction, perceived barriers, self-efficacy). 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 and older
Genders Eligible for Study:   Both
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
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:
Katz DA, Lounsbury P, Esham L, Graber M, Hillis S, Christensen AJ. Health beliefs toward cardiovascular risk reduction in patients admitted to chest pain observation units. J Gen Intern Med 2007; 22 (Suppl 1): 104.

Responsible Party: David A. Katz/Principal investigator, University of Iowa Carver College of Medicine
ClinicalTrials.gov Identifier: NCT00536224     History of Changes
Other Study ID Numbers: 0750112Z
Study First Received: September 25, 2007
Last Updated: March 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Health promotion
Emergency Medical Services
Randomized controlled trial

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

ClinicalTrials.gov processed this record on April 15, 2014