Rationale, design, and baseline data for a multicenter randomized clinical trial comparing depression screening strategies after acute coronary syndrome: The comparison of depression identification after acute Coronary Syndromes-Quality of Life and Cost Outcomes (CODIACS-QOL) trial

Contemp Clin Trials. 2019 Sep;84:105826. doi: 10.1016/j.cct.2019.105826. Epub 2019 Aug 13.

Abstract

Background: Elevated depressive symptoms among survivors of acute coronary syndromes (ACS) confer recurrent cardiovascular events and mortality, worse quality of life, and higher healthcare costs. While multiple scientific groups advise routine depression screening for ACS survivors, no randomized trials exist to inform this screening recommendation. We aimed to assess the effect of screening for depression on change in quality of life over 18 months among ACS patients.

Methods: The Comparison of Depression Identification after Acute Coronary Syndrome on Quality of Life and Cost Outcomes (CODIACS-QoL) trial is a pragmatic, 3-arm trial that randomized ACS patients to 1) systematic depression screening using the 8-item Patient Health Questionnaire (PHQ-8) and if positive screen (PHQ-8 ≥ 10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N = 499); 2) systematic depression screening and PCP notification only (Screen and Notify, N = 501); and 3) usual care (No Screen, N = 500). Adults hospitalized for ACS in the previous 2-12 months without prior history of depression were eligible for participation. Key outcomes will be quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18 months.

Results: A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years). Only 7% of ACS survivors had elevated depressive symptoms.

Conclusions: Using a novel randomization schema and pragmatic design principles, the CODIACS-QoL trial achieved its enrollment target. Eventual results of this trial will inform future depression screening recommendations in cardiac patients.

Trial registration: ClinicalTrials.gov (NCT01993017).

Keywords: Depression; Protocol; Screening.

Publication types

  • Clinical Trial Protocol
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Acute Coronary Syndrome / complications*
  • Acute Coronary Syndrome / psychology
  • Age Factors
  • Aged
  • Algorithms
  • Antidepressive Agents / therapeutic use
  • Cost-Benefit Analysis
  • Counseling / methods
  • Depression / diagnosis*
  • Depression / etiology*
  • Depression / therapy
  • Female
  • Health Status
  • Humans
  • Male
  • Mass Screening / economics
  • Mass Screening / methods*
  • Mental Health
  • Middle Aged
  • Patient Acceptance of Health Care
  • Primary Health Care / economics
  • Primary Health Care / methods*
  • Quality of Life
  • Referral and Consultation
  • Sex Factors
  • Single-Blind Method
  • Socioeconomic Factors

Substances

  • Antidepressive Agents

Associated data

  • ClinicalTrials.gov/NCT01993017