Clinical trial NCT01993017: Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes
Official title: Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Depressive Symptoms
Keywords: Acute Coronary Syndrome
Depressive Symptoms
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Duke University
name: HealthPartners Institute
name: Kaiser Foundation Research Institute
First posted: 2013-11-25
Enrollment: 1501
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

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screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn).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

Eligibility criteria: 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

Primary outcomes:
measure: Quality-Adjusted Life Years (QALYs)
timeFrame: Baseline, 6, 12 and 18 months
Secondary outcomes:
measure: Depression-free Days
timeFrame: Baseline through 18 months
measure: Cost of Health Care Utilization
timeFrame: Baseline through 18 months
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Health Partners institute for Research and Education
state: Minnesota
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Henderson
country: United States
facility: Duke University
state: North Carolina
city: Portland
country: United States
facility: Kaiser Foundation Research Institute
state: Oregon
Study officials:
affiliation: Columbia University
name: Ian M Kronish, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moise N, Davidson KW, Cheung YKK, Clarke GN, Dolor RJ, Duer-Hefele J, Ladapo JA, Margolis KL, St Onge T, Parsons F, Retuerto J, Schmit KM, Thanataveerat A, Kronish IM. Rationale, design, and baseline data for a multicenter randomized clinical trial comparing depression screening strategies after acute coronary syndrome: The comparison of depression identification after acute Coronary Syndromes-Quality of Life and Cost Outcomes (CODIACS-QOL) trial. Contemp Clin Trials. 2019 Sep;84:105826. doi: 10.1016/j.cct.2019.105826. Epub 2019 Aug 13.
citation: Kronish IM, Moise N, Cheung YK, Clarke GN, Dolor RJ, Duer-Hefele J, Margolis KL, St Onge T, Parsons F, Retuerto J, Thanataveerat A, Davidson KW. Effect of Depression Screening After Acute Coronary Syndromes on Quality of Life: The CODIACS-QoL Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):45-53. doi: 10.1001/jamainternmed.2019.4518.
citation: Ladapo JA, Davidson KW, Moise N, Chen A, Clarke GN, Dolor RJ, Margolis KL, Thanataveerat A, Kronish IM. Economic outcomes of depression screening after acute coronary syndromes: The CODIACS-QoL randomized clinical trial. Gen Hosp Psychiatry. 2021 Jul-Aug;71:47-54. doi: 10.1016/j.genhosppsych.2021.04.001. Epub 2021 Apr 3.