Ignite Creation Date:
2024-05-06 @ 7:50 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02611050
Status:
TERMINATED
Last Update Posted:
2018-06-27
First Post:
2015-11-09
Brief Title:
Treatment Decisions for Multi-vessel CAD
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Treatment Decisions for Multi-vessel Coronary Artery Disease Patients
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment was not feasible
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multi-center randomized trial to evaluate the Multi-vessel Coronary Artery Disease Option Grid patient decision aid compared to usual care in patient reported decisional conflict knowledge and shared decision making
Detailed Description:
Multi-vessel coronary artery disease can be treated through percutaneous coronary intervention coronary artery bypass grafting or medical therapy Treatments have risk benefit tradeoffs making patient preference integral to the treatment decision The Multi-vessel Coronary Artery Disease Option Grid patient decision aid was developed to improve the decision making process for patients and clinicians
Objectives
1 Evaluate The Multi-vessel Coronary Artery Disease Option Grid impact on patient treatment decisional conflict knowledge and shared decision making
The randomized controlled trial will compare validated and standardized measures of patient decisional conflict shared decision making and condition specific treatment knowledge between Option Grid and usual care patients The investigators hypothesize Option Grid patients will have improvements in patient decisional conflict shared decision making and knowledge compared to usual care patients Baseline feasibility enrollment at each site prior to randomization will be used to identify current treatment patterns and prepare intervention delivery and fidelity Registry data will be used to identify patient treatment received and compared between Option Grid and usual care arms
2 Examine the physician and patient process of and factors influencing Multi-vessel Coronary Artery Disease Option Grid use
Semi-structured interviews and process evaluations will be used to describe Option Grid use and experience and identify factors that are associated with beneficial Option Grid use
Objectives
1 Evaluate The Multi-vessel Coronary Artery Disease Option Grid impact on patient treatment decisional conflict knowledge and shared decision making
The randomized controlled trial will compare validated and standardized measures of patient decisional conflict shared decision making and condition specific treatment knowledge between Option Grid and usual care patients The investigators hypothesize Option Grid patients will have improvements in patient decisional conflict shared decision making and knowledge compared to usual care patients Baseline feasibility enrollment at each site prior to randomization will be used to identify current treatment patterns and prepare intervention delivery and fidelity Registry data will be used to identify patient treatment received and compared between Option Grid and usual care arms
2 Examine the physician and patient process of and factors influencing Multi-vessel Coronary Artery Disease Option Grid use
Semi-structured interviews and process evaluations will be used to describe Option Grid use and experience and identify factors that are associated with beneficial Option Grid use
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