Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes (CODIACSQoL)
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|ClinicalTrials.gov Identifier: NCT01993017|
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : October 27, 2017
|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screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn).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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
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.
Other: Cognitive Behavioral Therapy (CBT)
Drug: Antidepressant Medication
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.
Other Names:Other: Depressive symptom screener
8-item Patient Health Questionnaire, PHQ-8
Other Name: PHQ-8
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.
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
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.
|Other: No intervention|
- Quality Adjusted Life Years [ Time Frame: Baseline, 6, 12 and 18 months ]Change in QALYs from baseline through 18 months post-randomization will serve as the primary outcome for this trial
- Cost of health care utilization [ Time Frame: 18 months after enrollment ]Total cost of health care utilization from baseline through 18 months post-randomization
- Depression-free days [ Time Frame: Baseline, 6, 12, and 18 months ]Depression-free days from baseline through 18 months post-randomization
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 Researcha and Education|
|Bloomington, Minnesota, United States, 55440|
|United States, New York|
|New York, New York, United States, 10032|
|United States, North Carolina|
|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|