Recruitment

Recruitment Status
Completed
Estimated Enrollment
1500

Inclusion Criterias

Has access to a phone
With a documented acute coronary syndrome (ACS) within the past 2-12 months
Over the age of 21 years
Has access to a phone
With a documented acute coronary syndrome (ACS) within the past 2-12 months
Over the age of 21 years

Exclusion Criterias

Non-English and non-Spanish speaking
Non-English and non-Spanish speaking

Summary

Conditions
  • Acute Coronary Syndrome
  • Depressive Symptoms
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Screening

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

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)...

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screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn).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 AHA's 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.

Inclusion Criterias

Has access to a phone
With a documented acute coronary syndrome (ACS) within the past 2-12 months
Over the age of 21 years
Has access to a phone
With a documented acute coronary syndrome (ACS) within the past 2-12 months
Over the age of 21 years

Exclusion Criterias

Non-English and non-Spanish speaking
Non-English and non-Spanish speaking

Locations

Portland, Oregon, 97227
Henderson, North Carolina, 27536
New York, New York, 10032
Bloomington, Minnesota, 55440
...
Portland, Oregon, 97227
Henderson, North Carolina, 27536
New York, New York, 10032
Bloomington, Minnesota, 55440

Tracking Information

NCT #
NCT01993017
Collaborators
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Duke University
  • HealthPartners Institute
  • Kaiser Foundation Research Institute
Investigators
  • Principal Investigator: Ian M Kronish, MD, MPH Columbia University
  • Ian M Kronish, MD, MPH Columbia University