Translating Research: Patient Decision Support/Coaching
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational/Counseling/Training
Sponsored by
About this trial
This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Quality improvement, Patient-centered care, Acute coronary syndrome, Telephone counseling
Eligibility Criteria
Inclusion Criteria:
- age of 21 years or older,
- a documented serum Troponin I level of greater than, or equal to the upper limits of normal in each hospital, and
- a working diagnosis of ACS in the medical record.
Exclusion Criteria:
- inability to speak English or to complete the enrollment interview, and
- discharge to a non-home setting.
Sites / Locations
- Genesys Health System
- Hurley Hospital
- McLaren Health Systems
- Covenant Health System
- St. Mary's Hospital
Outcomes
Primary Outcome Measures
Secondary prevention behaviors (smoking, exercise)
Physical functioning (Activity Status Index)
Quality of life (Euroqol EQ5D)
Secondary Outcome Measures
Medication use
Full Information
NCT ID
NCT00416026
First Posted
December 26, 2006
Last Updated
December 26, 2006
Sponsor
Michigan State University
1. Study Identification
Unique Protocol Identification Number
NCT00416026
Brief Title
Translating Research: Patient Decision Support/Coaching
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Michigan State University
4. Oversight
5. Study Description
Brief Summary
The purpose of the study was to test a telephone counseling intervention for patients after leaving the hospital for a heart attack to use medication, exercise, healthy eating and smoking cessation to prevent further heart attacks.
Detailed Description
BACKGROUND: Efficacy of brief individual telephone coaching for secondary prevention behavior has been shown. However, the independent contribution of personal counseling to system-level intervention is untested. We tested a multiple-risk factor brief counseling intervention in acute coronary syndrome (ACS) following hospital-based quality improvement (QI) program.
METHODS: Patient-level randomized trial of hospital quality improvement (QI-only) versus quality improvement plus brief telephone coaching in the first three months post-hospitalization (QI-plus) for patients hospitalized for ACS. Data collection: medical record review, state vital records, and post-hospital surveys (baseline, 3 and 8 months post hospitalization). Main outcomes: secondary prevention behaviors, physical functioning, and quality of life.
RESULTS: QI-plus patients reported statistically significant independent improvements in physical activity (OR = 1.62; p = .01) during the intervention, and were more likely to participate in formal cardiac rehabilitation (OR = 2.51; p = .02). Smoking cessation was not statistically different (OR = 1.31; p = .68); functional status and quality of life were not different at 8 months. Medication use was high in QI and QI-plus groups, and improved over prior cohorts in the same hospitals.
CONCLUSION: QI improved physician and patient adherence to guidelines and improved medical therapy in-hospital continued in the outpatient setting. Brief telephone coaching was modestly effective in accomplishing short-term, but not long-term life-style behavior change. Patient life-style behavior change appears to require sustained intervention. QI-based improvement in medication use improves survival and appears to be the most efficient route to improved outcomes for all patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Quality improvement, Patient-centered care, Acute coronary syndrome, Telephone counseling
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Educational/Counseling/Training
Primary Outcome Measure Information:
Title
Secondary prevention behaviors (smoking, exercise)
Title
Physical functioning (Activity Status Index)
Title
Quality of life (Euroqol EQ5D)
Secondary Outcome Measure Information:
Title
Medication use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age of 21 years or older,
a documented serum Troponin I level of greater than, or equal to the upper limits of normal in each hospital, and
a working diagnosis of ACS in the medical record.
Exclusion Criteria:
inability to speak English or to complete the enrollment interview, and
discharge to a non-home setting.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret M Holmes-Rovner, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesys Health System
City
Flint
State/Province
Michigan
Country
United States
Facility Name
Hurley Hospital
City
Flint
State/Province
Michigan
Country
United States
Facility Name
McLaren Health Systems
City
Flint
State/Province
Michigan
Country
United States
Facility Name
Covenant Health System
City
Saginaw
State/Province
Michigan
Country
United States
Facility Name
St. Mary's Hospital
City
Saginaw
State/Province
Michigan
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17026412
Citation
Yang Z, Olomu A, Corser W, Rovner DR, Holmes-Rovner M. Outpatient medication use and health outcomes in post-acute coronary syndrome patients. Am J Manag Care. 2006 Oct;12(10):581-7.
Results Reference
result
PubMed Identifier
17062154
Citation
Stommel M, Olomu A, Holmes-Rovner M, Corser W, Gardiner JC. Changes in practice patterns affecting in-hospital and post-discharge survival among ACS patients. BMC Health Serv Res. 2006 Oct 24;6:140. doi: 10.1186/1472-6963-6-140.
Results Reference
result
PubMed Identifier
16738453
Citation
Dunn SL, Corser W, Stommel M, Holmes-Rovner M. Hopelessness and depression in the early recovery period after hospitalization for acute coronary syndrome. J Cardiopulm Rehabil. 2006 May-Jun;26(3):152-9. doi: 10.1097/00008483-200605000-00007.
Results Reference
result
PubMed Identifier
16787129
Citation
Holtrop JS, Corser W, Jones G, Brooks G, Holmes-Rovner M, Stommel M. Health behavior goals of cardiac patients after hospitalization. Am J Health Behav. 2006 Jul-Aug;30(4):387-99. doi: 10.5555/ajhb.2006.30.4.387.
Results Reference
result
PubMed Identifier
23151237
Citation
Olomu AB, Corser WD, Stommel M, Xie Y, Holmes-Rovner M. Do self-report and medical record comorbidity data predict longitudinal functional capacity and quality of life health outcomes similarly? BMC Health Serv Res. 2012 Nov 14;12:398. doi: 10.1186/1472-6963-12-398.
Results Reference
derived
PubMed Identifier
18416841
Citation
Corser W, Sikorskii A, Olomu A, Stommel M, Proden C, Holmes-Rovner M. "Concordance between comorbidity data from patient self-report interviews and medical record documentation". BMC Health Serv Res. 2008 Apr 16;8:85. doi: 10.1186/1472-6963-8-85.
Results Reference
derived
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Translating Research: Patient Decision Support/Coaching
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