Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00623493
Eligibility Criteria:
* INCLUSION CRITERIA:
Patient must complete triage assessment at the PEDIATRIC ED.
For the medical patients, triage level must be 2, 3, 4 or 5, and the patient must be medically stable. For medical patients in triage level 2, in order to determine if the patient is medically stable, the interviewer will contact the ED clinician (nurse or physician) prior to approaching the patient. Any patient deemed medically unstable will not be included in the study. For the psychiatric patients, leveling is not conducted in the same way. Therefore, triage level will not be considered an exclusion factor.
Triage level in the PEDIATRIC EDs is defined by the Emergency Severity Index (ESI). ESI is a five-level ED triage algorithm that uses acuity and resource needs to stratify patients into five clinically relevant groups from 1 (most urgent) to 5 (least urgent) (Gilboy, 2005).
Age: 10-21 years.
English speaking
A legal guardian must provide informed consent and patient must sign an assent document.
EXCLUSION CRITERIA:
Developmental disability, severe cognitive impairment or communication disorder such that patient will not be able to comprehend the questions or communicate their answers
Triage level of 1 (for medical patients), indicating that the patient is not medically stable
Patient is not present with a legal guardian who can provide informed consent
Patient is non-English speaking (unfortunately, the SIQ is not available at this time in Spanish or any other languages)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
21 Years
Study:
NCT00623493
Study Brief:
Protocol Section:
NCT00623493