Clinical trial NCT00536224: Chest Pain Observation Unit Risk Reduction Trial
Official title: Brief Intervention to Promote Cardiovascular Risk Reduction in Patients Admitted to Chest Pain Observation Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Keywords: Health promotion
Emergency Medical Services
Randomized controlled trial
Chest pain observation unit
Cardiovascular risk factors
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2007-09-27
Enrollment: 140
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking)
timeFrame: 2- and 6-months
measure: Self-reported cardiovascular health behaviors (diet, physical activity, and smoking cessation)
timeFrame: 2- and 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
Study officials:
affiliation: University of Iowa
name: David A Katz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katz DA, Graber M, Birrer E, Lounsbury P, Baldwin A, Hillis SL, Christensen AJ. Health beliefs toward cardiovascular risk reduction in patients admitted to chest pain observation units. Acad Emerg Med. 2009 May;16(5):379-87. doi: 10.1111/j.1553-2712.2009.00383.x. Epub 2009 Mar 16.
citation: Katz DA, Graber M, Lounsbury P, Vander Weg MW, Phillips EK, Clair C, Horwitz PA, Cai X, Christensen AJ. Multiple Risk Factor Counseling to Promote Heart-healthy Lifestyles in the Chest Pain Observation Unit: Pilot Randomized Controlled Trial. Acad Emerg Med. 2017 Aug;24(8):968-982. doi: 10.1111/acem.13231. Epub 2017 Jul 29.