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

April 12, 2023 updated by: Ian Kronish, Columbia University

Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn).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

Interventional

Enrollment (Actual)

1501

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Bloomington, Minnesota, United States, 55440
        • Health Partners institute for Research and Education
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
    • North Carolina
      • Henderson, North Carolina, United States, 27536
        • Duke University
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Foundation Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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: Depressive symptom screener
8-item Patient Health Questionnaire, PHQ-8
Other Names:
  • PHQ-8
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6, 12 and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression-free Days
Time Frame: Baseline through 18 months
Depression-free days from baseline through 18 months post-randomization
Baseline through 18 months
Cost of Health Care Utilization
Time Frame: Baseline through 18 months
Total cost of health care utilization from baseline through 18 months post-randomization
Baseline through 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Duke University
HealthPartners Institute
Kaiser Foundation Research Institute

Investigators

  • Principal Investigator: Ian M Kronish, MD, MPH, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAK9253
  • 1R01HL114924 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A deidentified data set and study materials will be provided upon request by other researchers.

IPD Sharing Time Frame

Starting in January 2021

IPD Sharing Access Criteria

Contact the study PI with data requests

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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