Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes (CODIACSQoL)
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| ClinicalTrials.gov Identifier: NCT01993017 |
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Recruitment Status :
Completed
First Posted : November 25, 2013
Results First Posted : December 18, 2019
Last Update Posted : November 11, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Coronary Syndrome Depressive Symptoms | Other: Cognitive Behavioral Therapy (CBT) Drug: Antidepressant Medication Other: Standard Care Other: Depressive symptom screener Other: No intervention | Not Applicable |
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screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn).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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1501 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Screening |
| Official Title: | Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes |
| Actual Study Start Date : | November 2013 |
| Actual Primary Completion Date : | July 31, 2018 |
| Actual Study Completion Date : | July 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: AHA Depression Screen & Treat
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.
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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 . Other Name: Problem Solving Therapy (PST) 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 Names:
Other: Depressive symptom screener 8-item Patient Health Questionnaire, PHQ-8
Other Name: PHQ-8 |
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Active Comparator: Depression Screen & Notify Arm Type :
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.
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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. Other: Depressive symptom screener 8-item Patient Health Questionnaire, PHQ-8
Other Name: PHQ-8 |
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Placebo Comparator: No Depression Screen
Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
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Other: No intervention |
- Quality-Adjusted Life Years (QALYs) [ Time Frame: Baseline, 6, 12 and 18 months ]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.
- Depression-free Days [ Time Frame: Baseline through 18 months ]Depression-free days from baseline through 18 months post-randomization
- Cost of Health Care Utilization [ Time Frame: Baseline through 18 months ]Total cost of health care utilization from baseline through 18 months post-randomization
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993017
| United States, Minnesota | |
| Health Partners institute for Research and Education | |
| Bloomington, Minnesota, United States, 55440 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Duke University | |
| Henderson, North Carolina, United States, 27536 | |
| United States, Oregon | |
| Kaiser Foundation Research Institute | |
| Portland, Oregon, United States, 97227 | |
| Principal Investigator: | Ian M Kronish, MD, MPH | Columbia University |
Documents provided by Ian Kronish, Columbia University:
Other Publications:
| Responsible Party: | Ian Kronish, Associate Professor of Medicine, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01993017 |
| Other Study ID Numbers: |
AAAK9253 1R01HL114924 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 25, 2013 Key Record Dates |
| Results First Posted: | December 18, 2019 |
| Last Update Posted: | November 11, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | A deidentified data set and study materials will be provided upon request by other researchers. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Analytic Code |
| Time Frame: | Starting in January 2021 |
| Access Criteria: | Contact the study PI with data requests |
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Acute Coronary Syndrome Depressive Symptoms |
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Acute Coronary Syndrome Syndrome Depression Disease Pathologic Processes Behavioral Symptoms Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Bupropion Sertraline Antidepressive Agents Antidepressive Agents, Second-Generation |
Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Serotonin Uptake Inhibitors Serotonin Agents |