Trial record 20 of 130 for:    heart attack OR myocardial infarction OR acute coronary syndrome | Open Studies | NIH, U.S. Fed

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Columbia University
Sponsor:
Collaborators:
Duke University
HealthPartners Institute for Education and Research
Kaiser Foundation Research Institute
Information provided by (Responsible Party):
Karina Davidson, Columbia University
ClinicalTrials.gov Identifier:
NCT01993017
First received: November 19, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 Intervention
Acute Coronary Syndrome
Depressive Symptoms
Other: Cognitive Behavioral Therapy (CBT)
Drug: Antidepressant Medication
Other: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Quality Adjusted Life Years [ Time Frame: Baseline, 6, 12 and 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression-free days [ Time Frame: Baseline, 6, 12, and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: November 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 meet with a study care specialist to discuss treatment options. Treatment will be delivered according to participant preference, and will be "stepped algorithm". Stepped care includes, a) participant preference for either brief, cognitive behavior therapy (CBT), delivered centrally, 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 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 .

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
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. Depending upon the provider's own evaluation of the participant, the participant may defer depression treatment, initiate treatment or may be referred to a mental health specialist.
Other: Standard Care
Participants will receive standard of 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.

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 three different, geographically diverse health maintenance organizations to three different groups: 1) to the AHA depression screen and treat if depression is found algorithm (intervention group) or: 2) to receive no depression screening (strong control group) or: 3) to be screened and a primary care provider notified (minimally enhanced 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.

  Eligibility

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking
  • With a documented acute coronary syndrome (ACS) within the past 2-6 months
  • Over the age of 21 years
  • Has access to a phone or computer

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:

  • Dementia
  • History of bipolar disorder
  • History of psychosis
  • History of major depression
  • History of suicide attempt or self-inflicted injurys
  • Current alcohol or substance abuse
  • Currently receiving depression treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993017

Locations
United States, Minnesota
Health Partners institute for Researcha and Education Not yet recruiting
Bloomington, Minnesota, United States, 55440
Contact: Karen Margolis, MD, MPH    952-967-7301    Karen.L.Margolis@healthpartners.com   
Principal Investigator: Karen Margolis, MD,MPH         
United States, New York
Columbia University Active, not recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke University Not yet recruiting
Henderson, North Carolina, United States, 27536
Contact: Kristine Schmit, MD, MPH    252-492-3152    kristine.schmit@duke.edu   
Principal Investigator: Kristine Schmit, MD,MPH         
United States, Oregon
Kaiser Foundation Research Institute Recruiting
Portland, Oregon, United States, 97227
Contact: Greg Clarke, PhD    503-335-6673    greg.clarke@kpchr.org   
Principal Investigator: Greg Clarke, PhD         
Sponsors and Collaborators
Columbia University
Duke University
HealthPartners Institute for Education and Research
Kaiser Foundation Research Institute
Investigators
Principal Investigator: Karina W Davidson, PhD Columbia University
  More Information

No publications provided

Responsible Party: Karina Davidson, Professor of Behavioral Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01993017     History of Changes
Other Study ID Numbers: AAAK9253, 1R01HL114924
Study First Received: November 19, 2013
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 09, 2014