Skip to main content
Clinical Trials/NCT00416026
NCT00416026CompletedNot Applicable

Translating Research: Patient Decision Support/Coaching

Michigan State University5 sites in 1 country304 target enrollmentStarted: January 1, 2002Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
304
Locations
5
Primary Endpoint
Secondary prevention behaviors (smoking, exercise)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
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.

Outcomes

Primary Outcomes

Secondary prevention behaviors (smoking, exercise)

Physical functioning (Activity Status Index)

Quality of life (Euroqol EQ5D)

Secondary Outcomes

  • Medication use

Investigators

Sponsor Class
Other

Study Sites (5)

Loading locations...

Similar Trials