The Missing Pieces Trial: A Comparison of Two Interventions to Support Parents After Their Child's Unexpected or Traumatic Death

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06136260
Collaborator
University of Chicago (Other), Patient-Centered Outcomes Research Institute (Other), Missing Pieces, a program of the HAP Foundation (Other)
2,000
6
2
48
333.3
6.9

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: CommunityRx-Bereavement
  • Other: General Bereavement Support Information
N/A

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 months after their child dies.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.
Primary Purpose:
Health Services Research
Official Title:
The Missing Pieces Trial: A Multi-Site Pragmatic Comparative Effectiveness Trial of Interventions to Support Parents After Their Child's Unexpected or Traumatic Death
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
Jul 1, 2027
Anticipated Study Completion Date :
Feb 1, 2028

Arms and Interventions

Arm Intervention/Treatment
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 call the parent; 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, calls 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 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
  • Outcome Measures

    Primary Outcome Measures

    1. Parent Self-efficacy for Finding Resources [~6 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 in your community that help you manage your grief?" Responses are on a 5-point Likert scale ranging from "not at all confident" to "completely confident."

    2. Complicated Grief [~6 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Parents or legal 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

    • Parents or legal caregivers who provide permission to the ME to be referred to Missing Pieces

    • Parent or legal caregivers who are referred to Missing Pieces by a ME

    • Parents or legal caregivers able to read and communicate in English or Spanish

    Exclusion Criteria:
    • Parents or legal caregivers unable to read or communicate in English or Spanish

    • Parents or legal caregivers under the age of 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cook County Medical Examiner's Office Chicago Illinois United States 60612
    2 Will County Coroner's Office Joliet Illinois United States 60432
    3 Kane County Coroner's Office Saint Charles Illinois United States 60175
    4 Lake County Coroner's Offic Waukegan Illinois United States 60085
    5 DuPage County Coroner's Office Wheaton Illinois United States 60187
    6 McHenry County Coroner's Office Woodstock Illinois United States 60098

    Sponsors and Collaborators

    • Ann & Robert H Lurie Children's Hospital of Chicago
    • University of Chicago
    • Patient-Centered Outcomes Research Institute
    • Missing Pieces, a program of the HAP Foundation

    Investigators

    • Principal Investigator: Kelly Michelson, MD, MPH, Lurie Children's Hospital
    • Principal Investigator: Stacy Lindau, MD, MAPP, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kelly Michelson, Attending Physician, Ann & Robert H Lurie Children's Hospital of Chicago
    ClinicalTrials.gov Identifier:
    NCT06136260
    Other Study ID Numbers:
    • 2023-6458
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kelly Michelson, Attending Physician, Ann & Robert H Lurie Children's Hospital of Chicago

    Study Results

    No Results Posted as of Nov 18, 2023