Translating Research: Patient Decision Support/Coaching

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT00416026
• Lead Sponsor: Michigan State University

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.

Study Timeline

• Study Start: 2002-01
• Study Completion: 2004-10
• Status Verified: 2006-12
• Study First Submitted: 2006-12-26
• Study First Submitted QC: 2006-12-26
• Last Update Submitted: 2006-12-26
• Study First Posted: 2006-12-27
• Last Update Posted: 2006-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Secondary prevention behaviors (smoking, exercise)
Physical functioning (Activity Status Index)
Quality of life (Euroqol EQ5D)

Secondary Outcome Measures

Name	Time	Method
Medication use

Trial Locations

Locations (5)

Covenant Health System; 🇺🇸 Saginaw, Michigan, United States

Genesys Health System; 🇺🇸 Flint, Michigan, United States

St. Mary's Hospital; 🇺🇸 Saginaw, Michigan, United States

Hurley Hospital; 🇺🇸 Flint, Michigan, United States

McLaren Health Systems; 🇺🇸 Flint, Michigan, United States