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:
NCT05064293
Eligibility Criteria:
Inclusions
* Patient is ≥ 4 and less than 7 months from the mental health emancipation age in the respective State on the date of randomization. That age is 13 years of age in WA and 12 years of age in CA. Therefore, we will include these subjects:
1. Participants 4 to 12 years, 150 days of age paneled to PC providers at KPWA clinics in the Seattle area;
2. Participants 4 to 11 years, 150 days of age paneled to PC providers at KPNC clinics in the East Bay sub-region.
* Treated in the internal delivery system and enrolled in a Kaiser Permanente insurance plan for at least 3 months prior to the PC note or MH diagnosis (index event);
* "Mental Health treatment naïve" per KP electronic records, defined as:
1. No previous ICD-9 or ICD-10 diagnosis for any MH condition;
2. No previous orders for MH prescription medication(s)
3. \>1 prior MH specialty visits..
* AND at least one of the following at the index encounter per KP records:
1. ICD-10 diagnosis code for a mental health condition (and no psychotherapy or pharmacotherapy ordered or initiated to treat the diagnosed condition as of the randomization date);
2. Documentation of mental health symptoms or complaints in the free text of a progress note or secure message in primary care or pediatrics (with no diagnosis made, and with no pharmacotherapy).
Exclusions
* Past ICD-10 diagnosis for a mental health condition associated with any encounter type or prescription order, internal or external to the system);
* Past mental health prescription medication ordered (including patient reported medication use, inpatient administration, past order for proposed off-label purpose, etc.);
* Documentation of mental health issues in the encounter note describes someone other than the child (e.g., a sibling or parent's issue)
* Note is from specialty, emergency or urgent care (i.e., not primary care or pediatrics).
* Subject is flagged as "interpreter needed" in Epic.
o Subject having a sibling from the same index encounter for mental health complaint
* Describe how individuals will be screened for eligibility.
We will identify potential participants automatically using diagnostic information and Natural Language Processing (NLP) of signed clinical notes from electronic health records (EHRs).
All potentially eligible subjects will be automatically added to an Epic reporting workbench (patient list) once per week. Study staff will confirm the eligibility of each listed patient via chart review. All participants confirmed eligible will be randomly assigned to a study arm (intervention, usual care control). Outcomes data will be collected using the standardized instruments and from the electronic records of all randomized participants for study analysis.
The MH navigator will review the medical record for each patient automatically identified for the study. This review will occur prior to any arm assignment. Those found to have exclusions will be marked ineligible. Participants deemed eligible will then be randomly assigned to one of two study arms.
Eligibility review will occur no later than 10 days following the index event.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT05064293
Study Brief:
Protocol Section:
NCT05064293