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Translating Research: Patient Decision Support/Coaching

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00416026
First Posted: December 27, 2006
Last Update Posted: December 27, 2006
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.
Information provided by:
Michigan State University
  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: None (Open Label)
Primary Purpose: Prevention

Further study details as provided by Michigan State University:

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

Secondary Outcome Measures:
  • Medication use

Estimated Enrollment: 304
Study Start Date: January 2002
Estimated Study Completion Date: October 2004
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00416026


Locations
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
Investigators
Principal Investigator: Margaret M Holmes-Rovner, PhD Michigan State University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00416026     History of Changes
Other Study ID Numbers: R01HS010531 ( U.S. AHRQ Grant/Contract )
First Submitted: December 26, 2006
First Posted: December 27, 2006
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