Eligibility Checklist s1
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Eligibility Checklist
FORM CODE: ELG Contact ID NUMBER: VERSION:A 0 0 SEQ # 0 1 Occasion 09/14/10
Administrative Information
0a. Completion Date: / / 0b. Staff ID: Month Day Year
Instructions: The Demographic Information and Part 1 of this form are initiated by the medical screener after ACS eligibility is determined by medical record review. Demographics and Part 1 are completed by chart abstraction. Affix the participant ID label above.
DEMOGRAPHIC INFORMATION 1. Age: years (greater than or equal to 35 is eligible)
2. Gender: Male Female
3. Ethnicity: Is patient of Latino, Hispanic, or Spanish origin? No Yes Unknown
4. Which of the following best describe(s) the patient’s race? (check one or more) a. White b. Black or African American c. Asian d. Native Hawaiian or other Pacific Islander e. American Indian or Alaska Native f. Other, specify: ______g. Unknown Part 1 INCLUSION CRITERIA 5. Does the patient have acute coronary syndrome (ACS) within the past 2-6 months? ...... N ...... Y 5a. If YES, choose ONE of the following indications: Unstable angina (ischemic chest pain lasting 20 min with recent onset or an accelerating pattern, or episodes at rest or with minimal effort, and at least one of the following: ischemic electrocardiographic changes (i.e. ST depression and/or T-wave abnormalities), an angiogram indicative of coronary artery disease on current admission, and/or documented history of coronary artery disease) Non-ST elevated myocardial infarction ST elevated myocardial infarction
Bundle branch block/uncertain type myocardial infarction
Eligibility Checklist (ELG) Page 1 of 4 ID #:
6. Is the patient fluent in English or Spanish? ...... N ...... Y
EXCLUSION CRITERIA Does the chart indicate the presence of: 7. Circumstances prohibiting the patient’s ability to complete follow-up assessments?...... N Y 8. A non-cardiac illness likely to be fatal within 1 year?...... N Y EXCLUSION CRITERIA (CONT’D) Does the chart indicate the presence of: 9. Serious cognitive impairment?...... N Y 10. Active suicidal ideation?...... N Y 11. Active alcohol or drug dependence?...... N Y 12. Major psychiatric co-morbidity? [see list of drugs suggestive of this in the QxQ]...... N Y 13. Chronic renal failure [chronic dialysis treatment or eGFR <30 ml/min/1.73 m2] or moderate- to-severe liver disease? ...... N ...... Y http://www.sheffield-kidney-institute.org/resources/gfr-calculator
13a. Serum creatinine: . μmol/L or mg/dL 13b: eGFR (mL/min/1.73 m2): 14. Being enrolled in another trial for the treatment of depression?...... N Y
Part 2 0c. Staff ID: Instructions: Part 2 of this form is initiated by the study coordinator if the chart review leads to a potential participant. The patient presents for the screening visit, consents to be screened, and then completes the screening assessments.
INCLUSION CRITERIA No Yes 15. Is the patient able to complete a baseline assessment within 2-6 months of hospitalization for the index ACS event? ...... N ...... Y 16. Is the patient willing to provide informed consent? ...... N ...... Y
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17. Does the patient have persistent depression? ...... N ...... Y (10 BDI < 15 on two occasions, or BDI 15 on one occasion, 2-6 months post-ACS) BDI value(s): a. b. EXCLUSION CRITERIA 18. Are there circumstances prohibiting the patient’s ability to complete follow-up assessments? ...... N ...... Y 19. Does the patient have serious cognitive impairment? ...... N ...... Y ( 2 incorrect answers on the 6-item MMSE) 20. Does the patient have active suicidal ideation? ...... N ...... Y (Score 2 for BDI item #9 and opinion of psychologist/psychiatrist upon consultation) 21. Does the patient have active alcohol or drug dependence? ...... N ...... Y (Meets criteria on the Psychiatric Disorder and Alcohol & Drug Abuse Screening Tool) 22. Does the patient have current or past history of major psychiatric co-morbidity (psychosis, bipolar disorder, or overt personality disorder)? ...... N ...... Y (Meets criteria on the Psychiatric Disorder and Alcohol & Drug Abuse Screening Tool) 23. Does the patient report having chronic renal failure or moderate-to-severe liver disease? (e.g., GI bleeding, esophageal varices, portal hypertension, encephalopathy) ...... N ...... Y 24. Is the patient enrolled in another trial for the treatment of depression?...... N Y
Eligible responses to all inclusion criteria are YES, and eligible responses to all exclusion criteria are NO
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25. Is the patient eligible for randomization?...... N Y (Written consent for the trial must be obtained prior to randomizing the patient.)
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