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

The Missing Pieces Trial: A Multi-Site Pragmatic Comparative Effectiveness Trial of Interventions to Support Parents After Their Child's Unexpected or Traumatic Death

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.

Study Overview

• Status: Recruiting
• Conditions: Bereavement
• Intervention / Treatment: Other: CommunityRx-Bereavement; Other: General Bereavement Support Information

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.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Michelson, MD, MPH; Phone Number: 312-227-4800; Email: kmichelson@luriechildrens.org
• Study Contact Backup: Name: Carolyn Sutter, PhD; Phone Number: 312-227-7059; Email: csutter@luriechildrens.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Cook County Medical Examiner's Office
    • Joliet, Illinois, United States, 60432
      • Recruiting
      • Will County Coroner's Office
    • Saint Charles, Illinois, United States, 60175
      • Recruiting
      • Kane County Coroner's Office
    • Waukegan, Illinois, United States, 60085
      • Recruiting
      • Lake County Coroner's Office
    • Wheaton, Illinois, United States, 60187
      • Recruiting
      • DuPage County Coroner's Office
    • Woodstock, Illinois, United States, 60098
      • Recruiting
      • McHenry County Coroner's Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Self-efficacy for Finding Resources	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."	~6.5 months after child's death
Complicated Grief	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.	~6.5 months after child's death

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: Patient-Centered Outcomes Research Institute; University of Chicago; Missing Pieces, a program of the HAP Foundation
• Investigators: Principal Investigator: Stacy Lindau, MD, MAPP, University of Chicago; Principal Investigator: Kelly Michelson, MD, MPH, Lurie Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: November 11, 2023
• First Submitted That Met QC Criteria: November 11, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; caregivers; self-efficacy; grief; community resources; coroners and medical examiners
• Other Study ID Numbers: 2023-6458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A full data package with the combined data will be created for the purpose of data sharing. During the study period (including data collection and analysis) access to the data will be restricted to the study team. Any secondary analysis of the dataset during the study period will need to be assessed and approved by the dual PIs, Dr. Michelson and Dr. Lindau with input from the steering committee at their discretion. This data package will be uploaded to a HIPAA-compliant, secure file sharing platform hosted by Lurie Children's Hospital and maintained by Lurie Children's Hospital for at least 7 years per PCORI requirements. Lurie Children's Hospital will be responsible for responding to Data Sharing related inquiries.
• IPD Sharing Time Frame: After the study period for at least 7 years

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No