Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes (CODIACSQoL)

Columbia University

Status: Completed

Conditions: Depressive Symptoms; Acute Coronary Syndrome

Treatments: Other: Standard Care; Other: Depressive symptom screener; Other: No intervention; Other: Cognitive Behavioral Therapy (CBT); Drug: Antidepressant Medication

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01993017

AAAK9253

1R01HL114924 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to examine, in a randomized controlled trial, the benefits and costs of the American Heart Association's (AHA) advisory for depression screen and treatment of post-acute coronary syndrome patients.

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screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn).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

Enrollment: 1,501 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Medical Exclusions:

• Terminal illness (life expectancy <1 year as determined by physician/medical record) defined as, but not limited to:
• NYHA class IV, ACC class D CHF requiring inotropes or mechanical assist devices or critical aortic stenosis without plan for correction
• End-stage COPD/emphysema
• Advanced cirrhosis with encephalopathy, varices, severe ascites
• Severe rheumatologic diseases requiring frequent hospitalizations, and multiple cytotoxic agents and/or disease modifying drugs
• Metastatic pancreatic, esophageal, colorectal or stomach cancer
• Metastatic sarcoma, ovarian, melanoma or renal cell cancer
• Metastatic breast cancer with multiple recurrences despite treatment
• Advanced CNS malignancies
• Recurrent hematologic malignancies with multiple recurrences despite treatment
• Persistent AIDS, untreated or treated

Psychiatric Exclusions:

• History of major depression
• Currently receiving depression treatment
• Dementia
• History of bipolar disorder
• History of psychosis
• History of suicide attempt or self-inflicted injuries
• Current alcohol or substance abuse

Other Exclusions:

• Non-English and non-Spanish speaking

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,501 participants in 3 patient groups, including a placebo group

AHA Depression Screen & Treat

Experimental group

Description:

Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, cognitive behavioral therapy (CBT), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.

Treatment:

Drug: Antidepressant Medication

Other: Cognitive Behavioral Therapy (CBT)

Other: Depressive symptom screener

Depression Screen & Notify Arm Type :

Active Comparator group

Description:

Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.

Treatment:

Other: Standard Care

Other: Depressive symptom screener

No Depression Screen

Placebo Comparator group

Description:

Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.

Treatment:

Other: No intervention