Translating Research: Patient Decision Support/Coaching
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Coronary Syndrome |
Behavioral: Educational/Counseling/Training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
- Secondary prevention behaviors (smoking, exercise)
- Physical functioning (Activity Status Index)
- Quality of life (Euroqol EQ5D)
- Medication use
| Estimated Enrollment: | 304 |
| Study Start Date: | January 2002 |
| Estimated Study Completion Date: | October 2004 |
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Michigan | |
| Hurley Hospital | |
| Flint, Michigan, United States | |
| McLaren Health Systems | |
| Flint, Michigan, United States | |
| Genesys Health System | |
| Flint, Michigan, United States | |
| St. Mary's Hospital | |
| Saginaw, Michigan, United States | |
| Covenant Health System | |
| Saginaw, Michigan, United States | |
| Principal Investigator: | Margaret M Holmes-Rovner, PhD | Michigan State University |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00416026 History of Changes |
| Other Study ID Numbers: | RO1-HS10531 |
| Study First Received: | December 26, 2006 |
| Last Updated: | December 26, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Michigan State University:
|
Quality improvement Patient-centered care Acute coronary syndrome Telephone counseling |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013