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

Acute Coronary Syndrome Clinical Trial

— CODIACSQoL  

Official title:

Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993017
• Other study ID #: AAAK9253
• Secondary ID: 1R01HL114924
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: July 31, 2019

Study information

• Verified date: April 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn).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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1501
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Depression
• Depressive Symptoms
• Syndrome

Intervention

Other:
• Cognitive Behavioral Therapy (CBT)
The main intervention is the impact of screening on quality of life and health care costs. CBT is provided only if depressive symptoms are detected and participant prefers this type of treatment. CBT will be centrally telephone-administered by a trained CBT treatment specialist. The treatment specialist will work with local team members throughout a participant's involvement in the study, and will closely follow each participant until he or she has reached a requisite level of improvement .

Drug:
• Antidepressant Medication
The main intervention is the impact of screening on quality of life and health care costs. Antidepressant Medication is provided only if depressive symptoms are detected and patient prefers this type of treatment. Antidepressants should be started at the lowest dose, but should be adjusted upward to be within the therapeutic range within 1 week, with further adjustment higher in the therapeutic range possible at 3-4 weeks. Dosage of the first medication selected will be in the therapeutic range by 3 weeks of the initial step, as tolerated.

Other:
• Standard Care
Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
• Depressive symptom screener
8-item Patient Health Questionnaire, PHQ-8
• No intervention

Locations

Country	Name	City	State
United States	Health Partners institute for Research and Education	Bloomington	Minnesota
United States	Duke University	Henderson	North Carolina
United States	Columbia University Irving Medical Center	New York	New York
United States	Kaiser Foundation Research Institute	Portland	Oregon

Sponsors (5)

Lead Sponsor	Collaborator
Columbia University	Duke University, HealthPartners Institute, Kaiser Foundation Research Institute, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 C — View 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; — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality-Adjusted Life Years (QALYs)	Change in QALYs from baseline through 18 months. QALYs are a generic measure of disease burden, including both the quality and the quantity of life lived. One QALY equates to one year in perfect health. To measure change in QALYs, utility scores [an overall assessment of well-being on a scale from 0 (death) to 1 (perfect health)], were estimated using the Short Form-6 dimension, with scores derived from responses to the 12-Item Short-Form Health Survey, version 2, at baseline and 6, 12, and 18 months. QALYs for the period from baseline to 18 months were then calculated as the area under the curve by linearly interpolating the utility scores at the 4 assessments. Change in QALYs was then obtained by subtracting the baseline QALY from the observed QALY for an 18-month period, where baseline QALY was calculated under the assumption that the baseline utility score remained constant during the 18-month period.	Baseline, 6, 12 and 18 months
Secondary	Depression-free Days	Depression-free days from baseline through 18 months post-randomization	Baseline through 18 months
Secondary	Cost of Health Care Utilization	Total cost of health care utilization from baseline through 18 months post-randomization	Baseline through 18 months