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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 : November 11, 2021
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

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE October 24, 2019
Results First Posted Date  ICMJE December 18, 2019
Last Update Posted Date November 11, 2021
Actual Study Start Date  ICMJE November 2013
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Depression-free days [ Time Frame: Baseline, 6, 12, and 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes
Official Title  ICMJE Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE
  • Acute Coronary Syndrome
  • Depressive Symptoms
Intervention  ICMJE
  • 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: 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
  • Other: No intervention
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Cognitive Behavioral Therapy (CBT)
    • Drug: Antidepressant Medication
    • Other: Depressive symptom screener
  • 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.
    Interventions:
    • Other: Standard Care
    • Other: Depressive symptom screener
  • 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.
    Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2017)
1501
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)
1500
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993017
Other Study ID Numbers  ICMJE AAAK9253
1R01HL114924 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: Starting in January 2021
Access Criteria: Contact the study PI with data requests
Responsible Party Ian Kronish, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Duke University
  • HealthPartners Institute
  • Kaiser Foundation Research Institute
Investigators  ICMJE
Principal Investigator: Ian M Kronish, MD, MPH Columbia University
PRS Account Columbia University
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP