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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993017
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
HealthPartners Institute
Kaiser Foundation Research Institute
Information provided by (Responsible Party):
Ian Kronish, Columbia University

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.

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

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screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn).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

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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
Study Start Date : November 2013
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

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:
  • Sertraline
  • Bupropion

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Depression-free Days [ Time Frame: Baseline through 18 months ]
    Depression-free days from baseline through 18 months post-randomization

  2. Cost of Health Care Utilization [ Time Frame: Baseline through 18 months ]

    Total cost of health care utilization from baseline through 18 months post-randomization

    *Note: There is a delay in reporting this outcome due to time required to compile and analyze electronic health record data from 4 health care systems.




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
HealthPartners Institute
Kaiser Foundation Research Institute
Investigators
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Principal Investigator: Ian M Kronish, MD, MPH Columbia University
  Study Documents (Full-Text)

Documents provided by Ian Kronish, Columbia University:
Study Protocol  [PDF] January 1, 2019
Statistical Analysis Plan  [PDF] January 1, 2019

Publications of Results:
Other Publications:
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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: December 18, 2019
Last Verified: December 2019
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
Keywords provided by Ian Kronish, Columbia University:
Acute Coronary Syndrome
Depressive Symptoms
Additional relevant MeSH terms:
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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