Translating Research: Patient Decision Support/Coaching

This study has been completed.
Sponsor:
Information provided by:
Michigan State University
ClinicalTrials.gov Identifier:
NCT00416026
First received: December 26, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  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

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
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
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014