A Targeted Approach To A Safer Use of Antipsychotics In Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 733
- 试验地点
- 8
- 主要终点
- Percent of Youths With Antipsychotic Orders at 6 Months
研究概览
简要总结
This study tests the effectiveness of an intervention treatment algorithm vs. usual care control in a practical clinical trial. Control arm providers will receive a standard medication alert in the electronic medical record (EMR) when initiating an antipsychotic prescription for an eligible patient. Intervention arm prescribers will receive an interactive medication alert in the EMR when prescribing for eligible patients and the patient and provider will enter the treatment algorithm (provider - medication alert plus clinical review by a child psychiatrist; patient - offer of personalized behavioral health navigation plus bridging therapy when appropriate). The study aims to recruit 800 eligible patients in 4 health systems.
详细描述
SUAY is a practical clinical trial designed to test the effectiveness of an intervention aiming to improve the targeted and safer use of antipsychotic medications by guiding clinician-prescribing behavior of antipsychotics for children aged ≥ 3 and < 18 years and encouraging psychosocial therapy for eligible youth. The intervention includes a medication best practice alert in Epic, consultation with a child and adolescent psychiatrist, and extra support for patients and families to improve behavioral health service access. The trial will be conducted in 4 non-academic health systems. Each health system will randomize prescribers to one of two study arms, intervention and control. During patient encounters, entering an antipsychotic for a potentially eligible patient will cause either the control or intervention medication alert to fire in the electronic medical record. The control arm medication alert will point prescribing clinicians to relevant Choosing Wisely® recommendations. The intervention arm medication alert will inform prescribers that:
- Antipsychotics are not recommended 1st line treatment for non-psychotic disorders;
- A child and adolescent psychiatrist (CAP) will review antipsychotic usage by youth;
- Expedited access to bridging therapy, behavior health navigation, and/or a proactive consultation with a CAP may be ordered.
The intervention medication alert will point prescribing clinicians to both Choosing Wisely® recommendations and to SUAY clinical prescribing guidelines. SUAY guidelines were developed by a national expert consensus panel in a prior phase of the study.
Analytic data will be collected from automated data sources at the health systems. The primary outcomes are percent of children ordered an antipsychotic medication at 6 months of follow up, and total person-months of antipsychotic orders placed for participants during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Waivers of consent have been obtained for providers and for patients/parents/guardians. None are informed of the study design or study activities by arm. The investigator is blind to study arm assignment of providers and patients. Only automated data collection is utilized for this practical trial. Study arm is masked for the programmer/analyst pulling outcomes data from health system records. Study arm will also be masked for study staff verifying study eligibility prior to the official study enrollment. Arm is not masked for study intervention staff (consulting psychiatrists, behavioral health navigators, bridging therapists) since these staff only interact with intervention arm subjects.
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is ≥ 3 and < 18 years of age at the time of the encounter at which the study alert fired (index date);
- •Patient is initiating a new episode of outpatient treatment with an antipsychotic medication. (New episodes are defined by no record of an antipsychotic medication being ordered within the health system as part of an outpatient care plan in the prior 180 days);
- •Study service (BH navigation, bridging therapy, CAP consult) ordered in Epic for the patient; (e.g., provider removed antipsychotic order and still ordered study services);
排除标准
- •Patient has a diagnosed psychotic disorder, mania, autism spectrum disorder, or intellectual disability;
- •Patient was enrolled in the SUAY pilot study;
- •The antipsychotic entered is prochlorperazine (Comazol®);
- •An outpatient antipsychotic order is entered by a temporary provider in the health system (e.g., "doc of the day"). Orders placed by temporary providers do not count towards the 180 day medication free period for defining a new episode of care.
- •The antipsychotic order was placed within an urgent care, emergency department, or inpatient setting (to avoid intervening during a crisis). Orders placed in these settings do not count towards the 180 day medication free period for defining a new episode of care.
- •Primary language is not English
结局指标
主要结局
Percent of Youths With Antipsychotic Orders at 6 Months
时间窗: 180 day period following index date
Measured by medication orders placed within the health system
Days' Supply of Antipsychotics Ordered for Youth
时间窗: 180 day period following index date
Average days' supply of antipsychotic medication (values fell between 1 and 180 days), as measured by the intended days' supply on the medication orders for each participant. Only orders placed within the health system were accounted for.
次要结局
- Change to Psychotropic Medication Treatment Plan(180 day period following index date)
- Percent of Youths Using Antipsychotics at 6 Months(180 day period following index date)
- Days' Supply of Antipsychotic Use by Youth(180 day period following index date)
- Emergency Department/Urgent Care Visit Frequency(180 day period following index date)
- Baseline and Follow-up Safety Assessments - BMI(index date to 180 days post-index date)
- Behavioral Health (BH) Navigation Acceptance(180 day period following index date)
- Use of Usual Care Therapy(180 day period following index date)
- Use of Bridging Therapy(180 day period following index date)
- Use of Usual Care Therapy Following Bridging Therapy(180 day period following index date)
- Baseline and Follow-up Safety Assessments - Safety Lab Tests(index date to 180 days post-index date)