Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416026
Status:
COMPLETED
Last Update Posted:
2006-12-27
First Post:
2006-12-26
Brief Title:
Translating Research Patient Decision SupportCoaching
Sponsor:
Michigan State University
Organization:
Michigan State University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 162 p 01 during the intervention and were more likely to participate in formal cardiac rehabilitation OR 251 p 02 Smoking cessation was not statistically different OR 131 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
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 162 p 01 during the intervention and were more likely to participate in formal cardiac rehabilitation OR 251 p 02 Smoking cessation was not statistically different OR 131 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None