Ignite Creation Date:
2024-05-06 @ 2:14 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01993017
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2013-11-19
Brief Title:
Comparison of Depression Identification After Acute Coronary Syndrome Quality of Life and Cost Outcomes
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Depression Screening RCT in ACS Patients Quality of Life and Cost Outcomes
Status:
COMPLETED
Status Verified Date:
2023-04
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:
CODIACSQoL
Brief Summary:
The purpose of this study is to examine in a randomized controlled trial the benefits and costs of the American Heart Associations AHA advisory for depression screen and treatment of post-acute coronary syndrome patients
Detailed Description:
Patients with an acute coronary syndrome ACS and comorbid depression have a 2-fold higher risk for recurrent ACS and mortality worse quality of life and higher costs of care than nondepressed ACS patients The strength of these observational findings prompted the American Heart Association AHA to advise that routine depression screening for ACS patients and referral for depression diagnosis and treatment as indicated occur Unfortunately there are no randomized controlled trials RCT to inform this potentially expensive screening recommendation Additionally screening guidelinesadvisories in the absence of RCT evidence have recently been extensively criticized and withdrawn This poses a serious dilemma for clinicians health care systems and for health care policy leaders A RCT is urgently needed to provide evidence for these different constituents about the costs and benefits of the AHA depression screen and treat algorithm
Two critical gaps in knowledge must be filled to determine if public health would be improved by the AHA strategy for depression screening in post-ACS patients 1 Does this strategy improve quality-adjusted life years for patients with a recent ACS 2 Is the cost of providing depression screening and any type of depression treatment within the acceptable and typical amounts reimbursed for health care services Our specific aim is to determine the quality-adjusted life year benefits and health care costs of following the AHAs advisory for depression screening and then referral for further diagnosis and treatment in post-ACS patients if depression is found To accomplish this aim we will randomize patients from four different geographically diverse health care systems to three different groups 1 to the AHA depression screen and treat if depression is found algorithm screen and treat intervention group or 2 to be screened and a primary care provider notified screen and notify intervention group or 3 to receive no depression screening control group Health-related quality of life depressive symptoms and costs will be obtained from all patients so that the benefits and the costs of these three different depression screening strategies can be compared
Two critical gaps in knowledge must be filled to determine if public health would be improved by the AHA strategy for depression screening in post-ACS patients 1 Does this strategy improve quality-adjusted life years for patients with a recent ACS 2 Is the cost of providing depression screening and any type of depression treatment within the acceptable and typical amounts reimbursed for health care services Our specific aim is to determine the quality-adjusted life year benefits and health care costs of following the AHAs advisory for depression screening and then referral for further diagnosis and treatment in post-ACS patients if depression is found To accomplish this aim we will randomize patients from four different geographically diverse health care systems to three different groups 1 to the AHA depression screen and treat if depression is found algorithm screen and treat intervention group or 2 to be screened and a primary care provider notified screen and notify intervention group or 3 to receive no depression screening control group Health-related quality of life depressive symptoms and costs will be obtained from all patients so that the benefits and the costs of these three different depression screening strategies can be compared
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL114924 | NIH | None | httpsreporternihgovquickSearch1R01HL114924 |