Translating Research: Patient Decision Support/Coaching

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00416026
Recruitment Status : Completed
First Posted : December 27, 2006
Last Update Posted : December 27, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Behavioral: Educational/Counseling/Training Not Applicable

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 : Interventional  (Clinical Trial)
Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2002
Study Completion Date : October 2004

Primary Outcome Measures :
  1. Secondary prevention behaviors (smoking, exercise)
  2. Physical functioning (Activity Status Index)
  3. Quality of life (Euroqol EQ5D)

Secondary Outcome Measures :
  1. Medication use

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00416026

United States, Michigan
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, United States
Sponsors and Collaborators
Michigan State University
Principal Investigator: Margaret M Holmes-Rovner, PhD Michigan State University

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00416026     History of Changes
Other Study ID Numbers: R01HS010531 ( U.S. AHRQ Grant/Contract )
First Posted: December 27, 2006    Key Record Dates
Last Update Posted: December 27, 2006
Last Verified: December 2006

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
Vascular Diseases