The Grief Navigation Trial: A Multi-Site Pragmatic Comparative Effectiveness Trial of Interventions to Support Parents After Their Child's Unexpected or Traumatic Death
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 7
- 主要终点
- Parent Self-efficacy for Finding Resources
研究概览
简要总结
Parents of children who die traumatically or unexpectedly from things like suicide or an overdose suffer from mental and physical health problems and can experience massive disruptions in their family life. For about half of these parents, the first, and sometimes only, interactions they have with the healthcare system when their child dies are with a medical examiner or coroner (hereafter 'ME'). But MEs have little to no training in helping grieving families, and there are no standards guiding medical examiners or coroners on how or even if they should help grieving families. This gap leaves parents to find the help they need on their own. This research will test two different strategies for addressing this gap in the healthcare system.
详细描述
Of approximately 60,000 annual deaths of people < 25 years old, ~45% occur unexpectedly or traumatically (e.g., from homicide, suicide, or unintentional injury) and become a medical examiner or coroner (hereafter 'ME') case. Parents and caregivers (hereafter 'parents') of these children suffer debilitating mental health issues like complicated grief and depression, physical problems and family dysfunction, and struggle to find support. Often, the ME is parents' sole point of contact with the healthcare system. Yet MEs have limited education, guidance, and tools to support bereaved parents. Scalable systems-level interventions are needed, at the point of ME care, to connect bereaved parents to critical supports.
This study will compare two interventions to facilitate care across healthcare settings for bereaved parents:
- CommunityRx-Bereavement (CRx-B), an evidence- and theory-based, low intensity, highly scalable intervention, and
- General bereavement support information (GBSI), a standardized treatment regimen developed from extant literature and current recommended standards for supporting parents after a child's death.
This is a pragmatic, multi-site 1:1 randomized controlled comparative effectiveness study using a type I hybrid design. CRx-B and GBSI will be carried out by Missing Pieces, a community-based organization. To learn about which strategy works better, the study team will ask parents to complete surveys ~6.5 months after their child dies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Randomization will occur after a medical examiner or coroner (ME) case is referred to Missing Pieces. Participants and MEs will be blinded to participants' treatment arm; Missing Pieces and study staff will be aware of intervention assignments. Missing Pieces will randomize all referred ME cases, (except cases referred from Lake County where the intervention has already been adopted into practice) to CRx-B or GBSI using the method of permuted blocks and the uniform random number function in Stata V17. To ensure balance of intervention arms by ME office, randomization will be stratified by ME office.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents or caregivers of ME cases involving a person < 25 years old from one of the following offices: Cook County Medical Examiners, Lake County Coroners, DuPage County Coroner, Will County Coroner, McHenry County Coroner, Kane County Coroner, Peoria County Coroner
- •Parents or caregivers who provide permission to the ME to be referred to Missing Pieces
- •Parent or caregivers who are referred to Missing Pieces by a ME
- •Parents or caregivers able to read and communicate in English or Spanish
排除标准
- •Parents or caregivers unable to read or communicate in English or Spanish
- •Parents or caregivers under the age of 18 years old
研究组 & 干预措施
CommunityRx-Bereavement (CRx-B)
干预措施: CommunityRx-Bereavement (Other)
General Bereavement Support Information (GBSI)
干预措施: General Bereavement Support Information (Other)
结局指标
主要结局
Parent Self-efficacy for Finding Resources
时间窗: ~6.5 months after child's death
Domain-specific item assessing self-efficacy related to support after a child's death, based on Bandura's Self-Efficacy Scale, "How confident are you in your ability to find resources to support you after your child's death?" Responses are on a 5-point Likert scale ranging from "not at all confident" to "completely confident."
Complicated Grief
时间窗: ~6.5 months after child's death
Index of Complicated Grief, 19-item tool that uses a 5-point Likert scale ("never" to "always"). Responses are scored 0 to 4 and totaled (0 to 76) with higher scores indicating more symptoms of grief.
次要结局
未报告次要终点
研究者
Kelly Michelson
Attending Physician
Ann & Robert H Lurie Children's Hospital of Chicago