NCT01993017|CompletedResultsDMC
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
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Sponsor study identifier
Secondary identifiers
NIH
interventional
1,501
1 country
4
Study Start
November 2013
Actual (reported)Primary Completion
July 31, 2018
Actual (reported)Study Completion
July 31, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2013
Actual (reported)November 19, 2013
Actual (reported)November 25, 2013
Actual (reported)July 31, 2018
Actual (reported)July 31, 2019
Actual (reported)December 18, 2019
Actual (reported)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
Depression-free Days
Baseline through 18 months
Cost of Health Care Utilization
Baseline through 18 months
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.
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.
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 .
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
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.
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.
Ian M Kronish, MD, MPH
Columbia University
1,501 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2013
First Posted
November 25, 2013
Study Start
November 2013
Actual (reported)Implementation Science Approach to Enhancing Depression Treatment in Collaborative Depression Care Settings ( DepCare )
Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
July 31, 2018
Actual (reported)Study Completion
July 31, 2019
Actual (reported)Last Updated
April 14, 2023
Results First Posted
December 18, 2019
Record last verified: 2023-04
A deidentified data set and study materials will be provided upon request by other researchers.
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Source: ClinicalTrials.gov.
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