- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00416026
Translating Research: Patient Decision Support/Coaching
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Michigan
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Flint, Michigan, United States
- Genesys Health System
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Flint, Michigan, United States
- Hurley Hospital
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Flint, Michigan, United States
- McLaren Health Systems
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Saginaw, Michigan, United States
- Covenant Health System
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Saginaw, Michigan, United States
- St. Mary's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Secondary prevention behaviors (smoking, exercise)
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Physical functioning (Activity Status Index)
|
Quality of life (Euroqol EQ5D)
|
Secondary Outcome Measures
Outcome Measure |
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Medication use
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Margaret M Holmes-Rovner, PhD, Michigan State University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HS010531 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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