Efficacy of the I-CARE Digital Health Intervention

Официальное название

I-CARE: Efficacy of a Digital Health Intervention to Reduce Suicidal Ideation During Psychiatric Boarding

Обзор

When presenting to an ED with suicide, self-harm or other mental health crises, youth may also experience "boarding", which is defined by the Joint Commission as "the practice of holding patients in the ED or another temporary location after the decision to admit or transfer has been made." A recent national survey of 88 US acute care hospitals conducted by our research team found that 98.9% of hospitals were boarding youth awaiting psychiatric hospitalization, for an average of 2-3 days. However, as illustrated in a systemic review, little research has focused on developing interventions to support youth during this highly vulnerable time. 3 I-CARE is a modular, blended digital health intervention facilitated by individuals who are not mental health clinical staff to teach youth evidence-based psychosocial skills during the boarding period. This study will evaluate I-CARE's efficacy using a patient-level randomized clinical trial (RCT), randomizing youth to receive standard safety supervision or I-CARE in addition to standard safety supervision. If found to the efficacious, I-CARE could be scaled-up in new settings with limited resources and has the potential to significantly improve the quality of care received by youth experiencing boarding.

Подробное описание

Suicide is the second leading cause of death among adolescents; from 2007 to 2017 suicide deaths tripled in youth 10 to 14 years. Emergency departments (EDs) at acute care hospitals increasingly serve as portals of care for youth with suicidal ideation or attempt. When these youth are deemed to require psychiatric hospitalization, the demand for beds often exceeds supply, leading to psychiatric boarding. To address this gap, a multidisciplinary team including pediatricians, psychologists and patient partners developed a modular digital intervention and associated training materials to deliver evidence-based psychosocial skills to youth during boarding. This program, entitled I-CARE (Improving Care, Accelerating Recovery \& Education), consists of 7 web-based animated videos and workbook exercises, facilitated by licensed nursing assistants who provide 1-on-1 safety supervision during boarding. Given that 1-on-1 safety supervision is the current standard of care at most hospitals, I-CARE requires minimal additional resources beyond those already available in these settings. The psychosocial skills included in I-CARE are grounded in cognitive behavioral therapy and were prioritized through a rigorous Delphi process evaluating their importance and feasibility to deliver during psychiatric boarding.

Вмешательства

• Поведенческое Improving Care, Accelerating Recovery & Education (ICARE)
  I-CARE is a brief, digital intervention designed for adolescents who are boarding in a medical hospital awaiting transfer to a psychiatric inpatient unit. It consists of 7 tablet-based animated video modules and workbook exercises, facilitated by individuals who are not mental health professionals. All modules are grounded in evidence-based practices, such as cognitive-behavioral therapy and dialectical behavior therapy.

Первичные конечные точки

• Depression Anxiety Stress Scales Youth Version (DASS-Y ) [Срок оценки: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 60 days (T4), and 90 days (T5) post-discharge]
• 9-item Concise Health Risk Tracking - Self-Report (CHRT-SR9) [Срок оценки: Baseline/hospital admission (T1), hospital discharge/approximately 72 hours after admission (T2), and 30 days (T3), 60 days (T4), and 90 days (T5) postdischarge]
• Harkavy-Asnis Suicide Scale (HASS) [Срок оценки: Time Frame: 30 days (T3), 60 days (T4), and 90 days (T5) postdischarge]

Критерии участия

Критерии включения

• Adolescents of any sex and gender, aged 12-17 years at ED visit or hospital encounter
• Presenting with suicide attempt or ideation, or self-harm
• Medically stable
• English-speaking
• Awaiting transfer for inpatient psychiatric care or disposition.

Критерии исключения

• Cognitive or developmental delays precluding participation (intellectual functioning <12 years of age)
• Behavioral limitations that preclude program participation
• Active psychosis
• Legal parent/caregiver unable to speak English or unavailable to provide consent (e.g. Wards of the State)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 4 центра

• Yale — New Haven
• Dartmouth College — Hanover
• Dartmouth Health — Lebanon
• Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT07150832 · LSRG-1-094-23 · STUDY00033318 · 2000039368 · FWA00000093 · STUDY02002242

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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