跳至主要内容
临床试验/NCT03704272
NCT03704272撤回不适用

Supervisory Neglect, Non-Accidental Trauma, Brief Intervention, and Treatment Referral (SunBrite)

Phoenix Children's Hospital0 个研究点目标入组 221 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
221
主要终点
Return visits to emergency department for any ICD-10 code

研究概览

简要总结

The Supervisory Neglect, Non-Accidental Trauma, Brief Intervention, and Treatment Referral (SunBrite) protocol is a family-empowered, risk mitigation strategy that targets families with young children who present to the ED with intracranial trauma. Based on the widely utilized screening, brief intervention, and referral to treatment (SBIRT) protocol, SunBrite has 3 core components: screening, brief motivational interview, and referral for treatment. PCH will: 1) engage community partnerships to support SunBrite development; 2) utilize participatory action research approach for design, implementation, process evaluation, and dissemination of the pilot program; and 3) evaluate intervention implementation and pilot outcomes. Over a 2-year period, this study will encompass a pilot intervention and implementation assessment and a randomized trial to evaluate outcomes. Implementation of SunBrite will yield rigorous scientific evidence for a sustainable, evidenced-based, widely-needed non-accidental (NAT) screening and intervention for families with young children.

详细描述

SunBrite is a novel, evidence-based intervention for non-accidental trauma (NAT) that has not, as yet, been implemented in any health care setting. Current programs targeting NAT vary widely, and there is insufficient research to conclude that these efforts have reduced re-admission rates(12,13). EDs primarily screen for risk factors associated with child abuse, focusing on their role in reporting and developing forensic evidence for investigations but not on risk reduction. While such efforts as embedding child protection teams in trauma programs are a starting point, much more needs to be done to develop a standard of care and empirically demonstrate efforts that reduce the risk of subsequent injury.

The overlap between non-accidental trauma (NAT) and inadequate caregiver supervision provides an opportunity to identify and intervene during earlier health care visits for children at risk for severe or fatal injury. Because head injuries account for over 80% of all suspected non-accidental injuries and over 90% of fatalities in the pediatric population, this intervention specifically targets all children ages 0-2 years who present in the Phoenix Children's Hospital (PCH) ED with a diagnosed head injury of any kind not resulting from a motor vehicle collision (MVC). These injuries include, but ae not limited to, abrasions, contusions, hematoma, ischemia, fractures, swelling or bruising. In this way, SunBrite expands the scope of detection for NAT to include injuries resulting from supervisory neglect.

PCH will implement the SunBrite pilot protocol in collaboration with key community partners who will be extensively involved in project design, implementation, and evaluation. In preparation for study recruitment, PCH and its partners will formalize the SunBrite process, create a curriculum, draft training tools to support the fidelity of SunBrite, finalize study materials (e.g., worksheets, data collection forms, interview scripts, consent documentation, and logic model), and conduct professional training. Once development is complete, pediatric patient families will be enrolled into the pilot program.

SunBrite study will utilize a simple, randomized, prospective study design, with 221 eligible pilot study participants randomized upon triage to one of two study arms: the control arm (73 families) or the treatment arm (148 families). Families in the control group will receive treatment as usual (TAU), which includes reporting to child welfare agencies when appropriate. In the treatment group, the patient/family will receive the SunBrite protocol, whose components include a screening, a brief intervention based in motivational interviewing (MI) techniques, and referral to treatment. All abuse and neglect, no matter the study arm, will be reported in accordance with hospital policy, federal and state laws.

All self-identified primary caregivers (legal guardians or parents) of children ages 0-2 who present in the PCH ED with a diagnosed intracranial injury will be automatically screened for eligibility. Caregivers will be initially screened by ED clinicians (e.g., physicians, nurse-practitioners) for eligibility based on age, injury (head), and method of injury (MOI) (non-MVC) using a standard clinical interview currently in place. All caregivers who screen positive based on these three criteria will then be deemed eligible for SunBrite. A trauma social worker will be notified by the ED that they have an eligible patient for consult. The social worker will meet the family and briefly describe the study and their eligibility. If they are willing to participate, the social worker will then obtain informed consent. All patient families will be fully consented in person in English or Spanish.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Control

No Intervention

Families in the control group will receive treatment as usual, which includes reporting to child welfare agencies when appropriate.

Treatment

Experimental

SunBrite

干预措施: SunBrite (Behavioral)

结局指标

主要结局

Return visits to emergency department for any ICD-10 code

时间窗: 12 months post enrollment

Measured by the number of admissions to the ED as recorded in the patient's medical chart.

次要结局

  • Complications from traumatic head injury(12 months post enrollment)
  • All illnesses and conditions of participant, including those unrelated to traumatic head injury(12 months post enrollment)
  • Cost savings(12 months post enrollment)
  • Frequency of re-hospitalization(12 months post enrollment)
  • Hospital lengths of stay(12 months post enrollment)

研究者

申办方类型
Other
责任方
Sponsor

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