Effect of Depression Screening After Acute Coronary Syndromes on Quality of Life: The CODIACS-QoL Randomized Clinical Trial.

Importance: Patients with acute coronary syndrome (ACS) and elevated depressive symptoms are at increased risk for recurrent cardiovascular events and mortality, worse quality of life, and higher health care costs. These observational findings prompted multiple scientific panels to advise universal depression screening in survivors of ACS prior to evidence from randomized screening trials. Objective: To determine whether systematically screening for depression in survivors of ACS improves quality of life and depression compared with usual care. Design, Setting, and Participants: A 3-group multisite randomized trial enrolled 1500 patients with ACS from 4 health care systems between November 1, 2013, and March 31, 2017, with follow-up ending July 31, 2018. Patients were eligible if they had been hospitalized for ACS in the previous 2 to 12 months and had no prior history of depression. All analyses were performed on an intention-to-treat basis. Interventions: Patients with ACS were randomly assigned 1:1:1 to receive (1) systematic depression screening using the 8-item Patient Health Questionnaire, with notification of primary care clinicians and provision of centralized, patient-preference, stepped depression care for those with positive screening results (8-item Patient Health Questionnaire score ≥10; screen, notify, and treat, n = 499); (2) systematic depression screening, with notification of primary care clinicians for those with positive screening results (screen and notify, n = 501); and (3) usual care (no screening, n = 500). Main Outcomes and Measures: The primary outcome was change in quality-adjusted life-years. The secondary outcome was depression-free days. Adverse effects and mortality were assessed by patient interview and hospital records. Results: A total of 1500 patients (424 women and 1076 men; mean [SD] age, 65.9 [11.5] years) were randomized in the 18-month trial. Only 71 of 1000 eligible survivors of ACS (7.1%) had elevated 8-item Patient Health Questionnaire scores indicating depressive symptoms at screening. There were no differences in mean (SD) change in quality-adjusted life-years (screen, notify and treat, -0.06 [0.20]; screen and notify, -0.06 [0.20]; no screen, -0.06 [0.18]; P = .98) or cumulative mean (SD) depression-free days (screen, notify and treat, 343.1 [179.0] days; screen and notify, 351.3 [175.0] days; no screen, 339.0 [176.6] days; P = .63). Harms including death, bleeding, or sleep difficulties did not differ among groups. Conclusions and Relevance: In patients with ACS without a history of depression, systematic depression screening with or without providing depression treatment did not alter quality-adjusted life-years, depression-free days, or harms. Trial Registration: ClinicalTrials.gov identifier: NCT01993017.

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.

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).

Cardiac patients' perceptions of neighboring patients' risk: influence on psychological stress in the ED and subsequent posttraumatic stress.

BACKGROUND: As many as 12% of acute coronary syndrome (ACS) patients screen positive for post-traumatic stress disorder (PTSD) symptoms due to their cardiac event, and emergency department (ED) factors such as overcrowding have been associated with risk for PTSD. We tested the association of patients' perceptions of their proximity to a critically ill patient during ED evaluation for ACS with development of posttraumatic stress symptoms (PSS) in the month after hospital discharge. METHODS: Participants were enrolled in the REactions to Acute Care and Hospitalization (REACH) study during evaluation for ACS in an urban ED. Participants reported whether they perceived a patient near them was close to death. They also reported their current fear, concern they may die, perceived control, and feelings of vulnerability on an Emergency Room Perceptions questionnaire. One month later, participants reported on PTSD symptoms specific to the cardiac event and ED hospitalization. RESULTS: Of 763 participants, 12% reported perceiving a nearby patient was likely to die. In a multivariate linear regression model [F(9757) = 19.69, p < .001, R2 adjusted = .18] with adjustment for age, sex, GRACE cardiac risk score, discharge ACS diagnosis, Charlson comorbidity index, objective ED crowding, and depression symptoms at baseline, perception of a nearby patients' likely death was associated with a 2.33 point (95% CI, 0.60-4.61) increase in 1 month PTSD score. A post hoc mediation analysis with personal threat perceptions [F(10,756) = 25.28, p < .001, R2 adjusted = .24] showed increased personal threat perceptions during the ED visit, B = 0.71 points on the PCL per point on the personal threat perception questionnaire, ß = 0.27, p = .001, fully mediated association of participants' perceptions of nearby patients' likely death with 1-month PTSD score (after adjustment for ED threat perceptions,) B = 0.89 (95% CI, -1.33 to 3.12), ß = 0.03, p = .43, accounting for 62% of the adjusted effect and causing the main effect to become statistically nonsignificant. CONCLUSIONS: We found patients who perceived a nearby patient was likely to die had significantly greater PTSD symptoms at 1 month. Awareness of this association may be helpful for designing ED patient management procedures to identify and treat patients with an eye to post-ACS psychological care.