Translating Research: Patient Decision Support/Coaching

Acute Coronary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416026
• Other study ID #: RO1-HS10531
• Status: Completed
• Phase: N/A
• First received: December 26, 2006
• Last updated: December 26, 2006
• Start date: January 2002
• Est. completion date: October 2004

Study information

• Verified date: December 2006
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. age of 21 years or older,

2. a documented serum Troponin I level of greater than, or equal to the upper limits of normal in each hospital, and

3. a working diagnosis of ACS in the medical record.

Exclusion Criteria:

1. inability to speak English or to complete the enrollment interview, and

2. discharge to a non-home setting.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Behavioral:
• Educational/Counseling/Training

Locations

Country	Name	City	State
United States	Genesys Health System	Flint	Michigan
United States	Hurley Hospital	Flint	Michigan
United States	McLaren Health Systems	Flint	Michigan
United States	Covenant Health System	Saginaw	Michigan
United States	St. Mary's Hospital	Saginaw	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary prevention behaviors (smoking, exercise)
Primary	Physical functioning (Activity Status Index)
Primary	Quality of life (Euroqol EQ5D)
Secondary	Medication use