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Chest Pain Observation Unit Risk Reduction Trial

Primary Purpose

Chest Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full counseling
Minimal counseling
Sponsored by
David A Katz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chest Pain focused on measuring Health promotion, Emergency Medical Services, Randomized controlled trial, Chest pain observation unit, Cardiovascular risk factors

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Iowa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm Description

Minimal counseling

Full counseling

Outcomes

Primary Outcome Measures

Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking)
Self-reported cardiovascular health behaviors (diet, physical activity, and smoking cessation)

Secondary Outcome Measures

Full Information

First Posted
September 25, 2007
Last Updated
April 24, 2018
Sponsor
David A Katz
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT00536224
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David A Katz
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
Health promotion, Emergency Medical Services, Randomized controlled trial, Chest pain observation unit, Cardiovascular risk factors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
Minimal counseling
Arm Title
1
Arm Type
Experimental
Arm Description
Full counseling
Intervention Type
Behavioral
Intervention Name(s)
Full counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Minimal counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking)
Time Frame
2- and 6-months
Title
Self-reported cardiovascular health behaviors (diet, physical activity, and smoking cessation)
Time Frame
2- and 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Katz, MD, MSc
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19302365
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.
Results Reference
background
PubMed Identifier
28748625
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.
Results Reference
result

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Chest Pain Observation Unit Risk Reduction Trial

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