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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • Parents or caregivers unable to read or communicate in English or Spanish - Parents or caregivers under the age of 18 years old

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
Single (Participant)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CommunityRx-Bereavement (CRx-B)
  • Other: CommunityRx-Bereavement
    The medical examiner or coroner will refer parents to an organization called Missing Pieces. Missing Pieces does not deliver healthcare services to grieving families; rather, Missing Pieces helps families find grief services in their community. For CRx-B, a Grief Navigator from Missing Pieces will text and/or call the parent after receiving the referral; share information about grief and support resources; learn what resources the parent needs for themselves and their family; send the parent a personalized list of grief and social support community resources called a HealtheRx via text, email, or mail; and plan future text message communications with bidirectional functionality and, if requested, subsequent calls or texts from the Grief Navigator to occur at least 3, 6, and 12 months after the child's death.
    Other names:
    • CRx-B
Active Comparator
General Bereavement Support Information (GBSI)
  • Other: General Bereavement Support Information
    The medical examiner or coroner will refer parents to an organization called Missing Pieces. Missing Pieces does not deliver healthcare services to grieving families; rather, Missing Pieces helps families find grief services in their community. For GBSI, Missing Pieces sends parents a unidirectional text message providing a link to a webpage with a general list of grief resources (e.g., support groups) and information about grief and bereavement within two weeks of the child's death and again 3, 6, and 12 months after the child's death.
    Other names:
    • GBSI

Recruiting Locations

Cook County Medical Examiner's Office
Chicago, Illinois 60612

Will County Coroner's Office
Joliet, Illinois 60432

Peoria County Coroner's Office
Peoria, Illinois 61603

Kane County Coroner's Office
Saint Charles, Illinois 60175

Lake County Coroner's Office
Waukegan, Illinois 60085

DuPage County Coroner's Office
Wheaton, Illinois 60187

McHenry County Coroner's Office
Woodstock, Illinois 60098

More Details

Status
Recruiting
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago

Study Contact

Kelly Michelson, MD, MPH
312-227-4800
kmichelson@luriechildrens.org

Detailed Description

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: 1. CommunityRx-Bereavement (CRx-B), an evidence- and theory-based, low intensity, highly scalable intervention, and 2. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.