Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes
CODIACSQoL
Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes
2 other identifiers
interventional
1,501
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedResults Posted
Study results publicly available
December 18, 2019
CompletedApril 14, 2023
April 1, 2023
4.7 years
November 19, 2013
October 24, 2019
April 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Depression-free Days
Baseline through 18 months
Cost of Health Care Utilization
Baseline through 18 months
Study Arms (3)
AHA Depression Screen & Treat
EXPERIMENTALParticipants 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.
Depression Screen & Notify Arm Type :
ACTIVE COMPARATORParticipants 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.
No Depression Screen
PLACEBO COMPARATORParticipants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
Interventions
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 .
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.
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.
8-item Patient Health Questionnaire, PHQ-8
Eligibility Criteria
You may qualify if:
- With a documented acute coronary syndrome (ACS) within the past 2-12 months
- Over the age of 21 years
- Has access to a phone
You may not qualify if:
- 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
- History of major depression
- Currently receiving depression treatment
- Dementia
- History of bipolar disorder
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Duke Universitycollaborator
- HealthPartners Institutecollaborator
- Kaiser Foundation Research Institutecollaborator
Study Sites (4)
Health Partners institute for Research and Education
Bloomington, Minnesota, 55440, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Duke University
Henderson, North Carolina, 27536, United States
Kaiser Foundation Research Institute
Portland, Oregon, 97227, United States
Related Publications (3)
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.
PMID: 31419605BACKGROUNDKronish 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.
PMID: 31633746RESULTLadapo 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.
PMID: 33933921RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ian Kronish, MD, MPH, Principal Investigator
- Organization
- Center for Behavioral Cardiovascular Health
Study Officials
- PRINCIPAL INVESTIGATOR
Ian M Kronish, MD, MPH
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
November 19, 2013
First Posted
November 25, 2013
Study Start
November 1, 2013
Primary Completion
July 31, 2018
Study Completion
July 31, 2019
Last Updated
April 14, 2023
Results First Posted
December 18, 2019
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Starting in January 2021
- Access Criteria
- Contact the study PI with data requests
A deidentified data set and study materials will be provided upon request by other researchers.